Catequentinib - Advenchen Laboratories/Jiangsu Chia Tai Tianqing Pharmaceutical
Alternative Names: AL-3818; ALTN; Anlotinib; Anlotinib hydrochloride; Anrotinib; FOCUS VLatest Information Update: 07 Mar 2024
At a glance
- Originator Advenchen Laboratories; Jiangsu Chia-Tai Tianqing Pharmaceutical
- Developer Advenchen Laboratories; Akeso Biopharma; Chia Tai Tianqing Pharmaceutical Group; Henan Cancer Hospital; Peking University People's Hospital; Tianquan Pharmaceutical
- Class Amines; Antineoplastics; Cyclopropanes; Ethers; Fluorinated hydrocarbons; Indoles; Quinolines; Small molecules
- Mechanism of Action Fibroblast growth factor receptor antagonists; Platelet-derived growth factor beta receptor antagonists; Proto oncogene protein c-kit inhibitors; Vascular endothelial growth factor receptor 3 antagonists; Vascular endothelial growth factor receptor-1 antagonists; Vascular endothelial growth factor receptor-2 antagonists
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Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity Yes
Highest Development Phases
- Marketed Non-small cell lung cancer
- Phase III Alveolar soft part sarcoma; Colorectal cancer; Gastric cancer; Leiomyosarcoma; Liver cancer; Nasopharyngeal cancer; Soft tissue sarcoma; Synovial sarcoma; Thyroid cancer
- Phase II Bone cancer; Cancer; Cervical cancer; Cholangiocarcinoma; Ewing's sarcoma; Fallopian tube cancer; Gastrointestinal cancer; Gastrointestinal stromal tumours; Glioblastoma; Head and neck cancer; Neuroendocrine tumours; Ovarian cancer; Pancreatic cancer; Peritoneal cancer; Renal cell carcinoma; Small cell lung cancer; Squamous cell cancer; Triple negative breast cancer; Urogenital cancer
- Phase I/II Acral lentiginous melanoma; Endometrial cancer
- No development reported Solid tumours
Most Recent Events
- 18 Jan 2024 Efficacy and adverse events data from the phase II ALTER-G-001 trial in Gastrointestinal cancer presented at Gastrointestinal Cancers Symposium (ASCO-GCS-2024)
- 20 Oct 2023 Efficacy and safety data from the phase II trial in cervical cancer presented at the 48th European Society for Medical Oncology Congress (ESMO-2023)
- 20 Oct 2023 Updated efficacy and safety data from the phase II neoALTALL trial in Triple-negative-breast-cancer presented at the 48th European Society for Medical Oncology Congress (ESMO-2023)
Development Overview
Introduction
Catequentinib (formerly anlotinib) is an orally bioavailable kinase inhibitor of receptor tyrosine, being jointly developed by Advenchen Laboratories and Jiangsu Chia-Tai Tianqing Pharmaceutical (a subsidiary of Sino Biopharmaceutical), for the treatment of advanced cancers. The antiangiogenic small molecule targets multiple receptor tyrosine kinases including, VEGFR1, VEGFR2, VEGFR3, FGFR1/2/3, PDGFRa/β, c-Kit and MET. Sino Biopharmaceutical classifies catequentinib under chemical drug level 1.1. The product is available in China, as a third line treatment of patients with non-small cell lung cancer. Clinical development for the treatment of triple negative breast cancer, alveolar soft part sarcoma, cervical cancer, colorectal cancer, cholangiocarcinoma, endometrial cancer, Ewing's sarcoma, fallopian tube cancer, gastric cancer, gastrointestinal stromal tumours, hepatocellular carcinoma (liver cancer), leiomyosarcoma, nasopharyngeal carcinoma, neuroendocrine tumours, pancreatic cancer, squamous cell cancer, ovarian cancer, peritoneal cancer, glioblastoma, renal cell carcinoma, small cell lung cancer, non-small cell lung cancer, soft tissue sarcoma, synovial sarcoma, solid tumours, acral lentiginous melanoma, thyroid cancer, gastrointestinal cancer and urogenital cancer is underway in several countries.
As at August 2023, no recent reports of development had been identified for phase-I development in Non-small-cell-lung-cancer (Combination therapy, First-line therapy, Late-stage disease, Locally recurrent) in China (PO), phase-I development in Solid-tumours (Combination therapy, Late-stage disease, Metastatic disease) in China (PO, Capsule), phase-I development in Triple-negative-breast-cancer (Combination therapy, Metastatic disease, Second-line therapy or greater) in China (PO, Capsule).
Company Agreements
In June 2019, Chia Tia Tianqing Pharmaceutical Group and Akeso Biopharma announced the formation of Joint venture to research and commercialize Penpulimab together. Under the terms of agreement Chia Tai Tianqing will act as Akeso’s clinical development and commercialization partner for AK105 in China. This joint venture will provide Akeso with access to Chia Tai Tianqing’s strong commercial capabilities. Akeso has an exclusive right to develop combination therapies using Chia Tai Tianqing’s anlotinib; Chia Tai Tianqing will obtain the exclusive sales and pricing rights for penpulimab (AK105). Akeso provides all rights, title and interest in penpulimab (AK105) in exchange for 50% interest in the joint venture; Chia Tai Tianqing invests approximately Rmb344.7 mn in cash in exchange for 50% interest in the joint venture. [1]
Advenchen Laboratories entered into a research and development agreement Jiangsu Chia-Tai Tianqing Pharmaceutical to co-develop anlotinib for the treatment of cancer (Advenchen Laboratories website, September 2015).
Key Development Milestones
Non-small cell lung cancer
In May 2018, Chia-Tai Tianqing Pharmaceutical received approval for catequentinib capsules from the China Food and Drug Administration, as the third line treatment of patients with advanced non-small cell lung cancer. The company subsequently launched the product under the brandname FOCUS V® in China [2] .
In May 2020, Chia Tai Tianqing Pharmaceutical initiated a phase III trial to evaluate the efficacy and safety of TQB 2450 [See Adis Insight Drug profile 800053691]with or without catequentinib compared with placebo as consolidation treatment in subjects with locally advanced/unresectable (stage III) non-small cell lung cancer that has not progressed after prior concurrent/sequential chemoradiotherapy (NCT04325763; TQB2450-III-05). Primary objective of the trial is progression free survival (PFS) evaluated by independent review committee (IRC). A randomized, double-blind and imitation, placebo parallel control, multicenter phase III trial is designed to enroll 315 patients in China [3] .
In August 2019, Chia Tai Tianqing Pharmaceutical initiated a phase III trial to evaluate efficacy and safety of catequentinib combined with chemotherapy versus placebo combined with chemotherapy as first-line treatment in patients with advanced non-small cell lung cancer (ALTN-03-III-01; NCT04439890). The open label, randomised trial is enrolling 369 patients in China [4]
In January 2017, Jiangsu Chia-tai Tianqing completed the phase II/III ALTER0303 trial that indicated overall survival at 24 months, after treatment with catequentinib, thus meeting the defined endpoint in patients with advanced non-small cell lung cancer (NSCLC), compared with placebo (ALTN-03-IIB; NCT02388919). Eligible IIIB/IV NSCLC patients harbouring EGFR or ALK mutations, who progressed after at least two lines of prior therapies, were randomised 2:1 to receive catequentinib or placebo (12 mg, once-daily) till progression or intolerable toxicity. The double-blind, multi-center trial was initiated in February 2015 and enrolled 439 patients in China. In June 2017, data from the phase III portion of the trial were presented at the 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO-2017) [5] [6] [7] .
In June 2022, Chia Tai Tianqing Pharmaceutical initiated the phase II ALTER-E005 clinical trial to assess the efficacy and safety of anlotinib hydrochloride capsules combined with APL 502 [see AdisInsight drug profile 800053691] injection in esophageal squamous cell carcinoma patients as postoperative adjuvant therapy (NCT05252078; 2021ky222). The open-label trial intends to enrol approximately 30 patients in China [8] .
In May 2022, Chia Tai Tianqing Pharmaceutical initiated a phase II trial to assess the effiacy and safety of penpulimab and anlotinib plus chemo-less therapy as fist-line therapy for persistent, recurrent, or metastatic cervical cancer(ChiCTR2200062897; K2022-078-01; ALTN-AK105-II-06). The trial intends to enroll 30 patients in China [9] . In October 2023, data from the trial was presented at 48th European Society for Medical Oncology Congress (ESMO-2023) [10] .
Before September 2021, Hunan Cancer Hospital in collaboration with Chia-tai Tianqing Pharmaceutical completed a phase II trial which evaluated the catequentinib plus docetaxel versus docetaxel for the treatment of EGFR negative advanced non-small-cell lung cancer after disease progression on platinum-based therapy (NCT03624309; ALTER-L018). The open-label trial met its primary end point. It was initiated in October 2018 and enrolled 84 patients in China [11] .
In November 2020, Chia Tai Tianqing Pharmaceutical initiated a phase II trial of anlotinib hydrochloride combined with docetaxel in EGFR mutations advanced non small cell lung cancer patients who have progressed after targeted therapy and chemotherapy (NCT04619563; SDZLEC2020-052-02). The open label, exploratory trial intends to enrol approximately 42 patients in China [12] .
In November 2021, Chia Tai Tianqing Pharmaceutical completed the phase II ALTER-L029 trial that evaluated the efficacy and safety of catequentinib following concurrent chemoradiation in patients with stage III unresectable non-small cell lung cancer (2018YJZ47; NCT03743129). The open label trial was initiated in April 2019 and enrolled 90 patients in China [13] .
In December 2013, Jiangsu Chia-tai Tianqing Pharmaceutical initiated a phase II trial, which is evaluating the pharmacodynamics of catequentinib in patients with advanced non-small cell lung cancer (ALTN-03-II 1.2-2; NCT02029209). The randomised, double-blind, placebo-controlled trial will enrol approximately 110 patients who have previously failed two lines of chemotherapy in China [14] .
Jiangsu Chia-tai Tianqing Pharmaceutical initiated the randomised, double-blind, placebo-controlled phase II ALTER0302 trial in August 2013, to assess the efficacy and safety of catequentinib in patients with advanced, heavily pretreated non-small cell lung cancer (ALTN-03-II; NCT01924195). The trial enrolled 117 patients in China, and was completed in October 2015 [15] .
Akeso initiated a Ib/II trial to evaluate cadonilimab (AK 104) [See Adis Insight Drug profile 800038084] plus catequentinib (anlotinib) in patients with non-small cell lung cancer (NSCLC), before April 2021 (AK104-208; NCT04646330). The single arm, two cohorts, randomised study intends to enrol approximately 120 participants in China. In September 2021, the company presented efficacy and safety data from the trial at the 46th European Society for Medical Oncology Congress (ESMO-2021) [16] [17] .
Prior to January 2021, Chia Tai Tianqing Pharmaceutical initiated a phase I/II trial of anlotinib in combination with TQB 2450 [see AdisInsight RDI 800053691] in EGFR+ advanced non-small scale lung cancer patients, who failed prior EGFR TKI therapies (ChiCTR1900026273; ALTER-L038). The trial intends to enroll approximately 63 patients in China [18] . In June 2021, initial efficacy and safety data from the trial presented at the 57th Annual Meeting of the American Society of Clinical Oncology (ASCO-2021) [19] .
In December 2018, Chia Tai Tianqing Pharmaceutical Group and Sichtrial to uan Cancer Hospital and Research Institute initiated a phase I/II to investigate the safety and efficacy of catequentinib in combination with platinum and pemetrexed in T790M mutation negative, metastatic non-squamous non-small cell lung cancer (NSCLC) after the failure of EGFR-tyrosine kinase inhibitors (TKIs) (NCT03706287; ALTER-L022). The primary objective of study is to determine progression free survival, dose limiting toxicities and maximum tolerated dose. The open-label trial intends to enrol approximately 62 patients in China [20] .
In May 2023, Chia Tai Tianqing Pharmaceutical completed a phase I trial of APL 502 combined with catequentinib in non-small cell lung cancer. In June 2019, Chia Tai Tianqing Pharmaceutical initiated a phase I trial to evaluate the safety and efficacy of APL 502 injection combined with catequentinib in patients with advanced non-small cell lung cancer (TQB2450Ib01; NCT03910127). The randomised, double-blind trial enrolled approximately 90 patients in China [21] .
In March 2019, Chia Tai Tianqing Pharmaceutical initiated a phase I trial to evaluate efficacy and safety of anlotinib combined with pemetrexed and carboplatin followed by maintenance therapy with anlotinib plus pemetrexed as the first-line treatment in patients with advanced non-squamous non-small scale lung cancer (NCT03790228; ALTER L012). The open-label trial intends to enroll approximately 43 patients in China [22] . In June 2021, initial safety and efficacy results from the trial were presented at the 57th Annual Meeting of the American Society of Clinical Oncology (ASCO-2021). In June 2022, results from tis trial were presented at the 58th Annual Meeting of the American Society of Clinical Oncology [23] [24] .
catequentinib has also demonstrated anti-tumour efficacy in human HT29 colon cancer, Bel-7402 liver cancer xenografts and human A549 non-small cell lung cancer xenografts.
Breast cancer
In January 2021, Chia Tai Tianqing Pharmaceutical initiated the phase II neoALTALL trial to evaluate the efficacy and safety of anlotinib combined with taxanes and lobaplatin in the neoadjuvant treatment of triple-negative breast cancer (ChiCTR2100043027; SWH-B006). The trial completed enrollment of 45 patients in China, prior to December 2022. In December 2022, Efficacy and safety data from the trial were presented at the the 45th Annual San Antonio Breast Cancer Symposium. In October 2023, updated data were presented at the 48th European Society for Medical Oncology Congress (ESMO-2023) [25] [26] [27] .
In May 2019, Chia Tai Tianqing Pharmaceutical initiated a phase I trial to evaluate the efficacy and safety of TQB 2450 [see Adis profile 800053691] in combination with anlotinib treatment for patients with triple receptor negative breast cancer treated after failure of standard therapy (TQB2450Ib07; NCT03855358). The open label trial intends to enrol approximately 30 patients in China [28] . In June 2021, data were presented at the 57th Annual Meeting of the American Society of Clinical Oncology (ASCO-2021) [29] . In June 2022, data from the trial were presented at the 58th Annual Meeting of the American Society of Clinical Oncology (ASCO-2022) [30] .
Gastrointestinal cancer
In December 2021, Chia Tai Tianqing Pharmaceutical initiated a phase II ALTER-G-001 clinical trial to evaluate the efficacy and safety of catequentinib combined with chemotherapy as first-line and maintenance therapy for gastrointestinal tumours with unresectable liver metastases (NCT05262335; 2021223; ChiCTR2100050872). The open-label, non-randomised trial intends to enrol approximately 101 participants in China [31] . In June 2023, data from the trial was presented at the 59th Annual Meeting of the American Society of Clinical Oncology (ASCO-2023) and 25th World Congress on Gastrointestinal Cancer (WCGC-2023) [32] [33] . In January 2024, data from the trial were presented at Gastrointestinal Cancers Symposium (ASCO-GCS-2024) [34] [35] .
Gastrointestinal stromal tumours (GIST)
In October 2018, Chia-Tai Tianqing Pharmaceutical initiated a phase II trial exploring catequentinib in the treatment of GIST patients, who failed prior imatinib therapy (NCT04106024; 2018YJZ42). The open label trial is enrolling approximately 60 patients in the US [36] .
Glioblastoma
In September 2021, Nanjing University Medical School in collaboration with Chia Tai Tianqing Pharmaceutical initiated phase II trial to investigate the safety and efficacy of penpulimab [See ADIS Insight Drug Profile 800050249] with anlotinib (catequentinib) and radiotherapy adjuvant therapy in MGMT unmethylated newly diagnosed glioblastoma (NCT05033587; 2021-252-02). The open-label single-arm, exploratory, two-stage design trial intends to enroll approximately 28 participants in China [37] .
Pancreatic cancer
In June 2022, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School in collaboration with Chia Tai Tianqing Pharmaceutical Group initiated a phase II trial to assess the efficacy and safety of penpulimab (see AdisInsight drug profile 800050259) and catequentinib (anlotinib) in combination with nab-paclitaxel plus gemcitabine as first-line Therapy in patients with advanced metastatic pancreatic cancer ( 2022-351-02; NCT05493995). The open-label trial intends to enroll approximately 66 patients in China [38] .
Sarcoma
In June 2017, the US FDA granted orphan drug designation (ODD) to catequentinib for the treatment of soft tissue sarcoma [39] .
In February 2022, Chia Tai Tianqing Pharmaceutical initiated a phase III trial to evaluate the efficacy and safety of anotinib hydrochloride capsule combined with epirubicin hydrochloride versus placebo combined with epirubicin hydrochloride in first-line treatment of advanced soft tissue sarcoma (NCT05121350; ALTN8546-04; ALTN-III04). The double-blind, multicentre, parallel, prospective, randomised trial intends to recruit around 256 patients in China [40] .
In August 2017, Advenchen Laboratories initiated the phase III APROMISS trial to evaluate the safety and efficacy of catequentinib in patients with metastatic or advanced alveolar soft part sarcoma, leiomyosarcoma and synovial sarcoma (AL3818-US-004; NCT03016819). The open-label, crossover, randomised trial will enrol approximately 219 patients in the US and Italy [41] . As of June 2021, enrolment of patients for synovial sarcoma has been completed in the trial. In June 2021, efficacy and safety data from the trial in synovial sarcoma were presented at the 57th Annual Meeting of the American Society of Clinical Oncology (ASCO-2021) [42] . In November 2022, Advenchen Laboratories initiated a expanded access trial an Open Label post-trial Access (PTA) of Catequentinib (AL3818, Anlotinib) Hydrochloride mono or in combination therapies in patients who have completed an advenchen sponsored oncology study with AL3818 for Sarcoma (A Compassionate Use Trial) (NCT05612191; AL3818-PTA) [43] .
Jiangsu Chia-tai Tianqing initiated the phase II/III ALTER0203 trial to evaluate catequentinib in patients of soft tissue sarcoma (ALTN-02-IIB; NCT02449343). The randomised, double-blind and placebo-controlled trial intends to enrolled 233 patients in China. Progression free survival will be evaluated as a primary endpoint in the study. In September 2019, efficacy and safety data were presented at the 44th European Society for Medical Oncology Congress (ESMO-2019) [44] [45] [46] . In May 2020, the company presented efficacy data from the trial at the 56th Annual Meeting of the American Society of Clinical Oncology (ASCO-2020) [47] .
In April 2020, Chia Tai Tianqing Pharmaceutical initiated a phase II trial to evaluate safety and efficacy of catequentinib for the treatment of recurrent high grade glioma (NCT04822805; H2CH2020M504). The Open-label, single arm study intends to enrol 27 patients in China [48] . In September 2021, the company presented the interim safety and efficacy data at 46th European Society for Medical Oncology Congress [49] .
In January 2018, Peking University People's Hospital initiated a phase II study to explore the activity of catequentinib combined with irinotecan [see Adis Insight drug profile800000748] in patients with relapsed and metastatic Ewing Sarcoma (PKUPH-EWS-02; NCT03416517). The primary outcome measure of the study is to measure objective response rate at 12 weeks. The open-label study intends to enrol approximately 22 patients in China [50] . In September 2022, results from the trial were presented at the 47th European Society for Medical Oncology Congress (ESMO-2022) [51]
In June 2018, Jiangsu Chia-tai Tianqing Pharmaceutical completed the phase II ALTN/STS trial that assessed the safety and efficacy of catequentinib as second-line therapy in patients with advanced soft tissue sarcoma (ALTN-02-II; NCT01878448). The primary endpoint was tumour size which was assessed every 42 days up to 48 months. The open-label trial was initiated in April 2013 and enrolled 166 patients in China [52] .
In June 2019, Chia Tai Tianqing Pharmaceutical initiated a phase Ib trial to evaluate the safety and efficacy of catequentinib in combination with APL 502 injection (see AdisInsight drug profile 800053691) in patients with advanced mutation positive non-small cell lung cancer (TQB2450-Ib-11; NCT03983928). The open-label, non-randomised trial intends to enrol approximately 30 patients in China [53] .
Squamous cell cancer (Oesophagus)
As of June 2023, Chia Tai Tianqing Pharmaceutical in collaboration with Henan Cancer Hospital initiated a phase II trial to evaluate efficacy and safety of Paclitaxel+Cisplatin+TQB 2450 [see ADIS Insight profile 800053691] injection combined with or without anlotinib in the first-line treatment of advanced esophageal squamous cell carcinoma (NCT05013697; TQB2450-II-13). The open-label, non-randomized trial intends to enroll approximately 48 participants in China [54] . In June 2023, efficacy and adverse events data from the trial presented at the 59th Annual Meeting of the American Society of Clinical Oncology (ASCO-2023) [55] .
As of January 2023, Chia Tai Tianqing Pharmaceutical in collaboration with The First Affiliated Hospital of Zhengzhou University initiated a phase II trial to evaluate the safety and efficacy of APL 502 [see ADIS insight profile 800053691] in combination with catequentinib in patients with squamous cell cancer (NCT05038813; ALTER-E-003). The open-label phase II study intends to enrol 46 patients in China [56] . In June 2023, preliminary data from the trial presented at the 59th Annual Meeting of the American Society of Clinical Oncology (ASCO-2023) [57] .
Chia-tai Tianqing Pharmaceutical, in July 2018, completed the phase II ALTER1102 that investigated the efficacy and safety of catequentinib with placebo in patients with oesophageal squamous cell carcinoma (ALTN-11-II; NCT02649361). The primary end point of the trial was to determine progress free survival (PFS) from randomisation each 42 days up to 24 months. The randomised, double-blind trial was initiated in January 2016 and recruited 164 participants in China [58] .
In October 2019, Henan Cancer Hospital and Chia-tai Tianqing Pharmaceutical initiated a phase II trial evaluating catequentinib in the first-line treatment for patients with advanced oesophageal squamous cell carcinoma in combination with paclitaxel, cisplatin (2019315; NCT04063683). The open label trial intends to enrol approximately 47 patients in China [59] . In June 2021, data from the trial were presented at the 57th Annual Meeting of the American Society of Clinical Oncology (ASCO-2021) [60] .
Thyroid cancer
In December 2019, Jiangsu Chia-tai Tianqing Pharmaceutical completed the phase II/III ALTER01032 trial that compared the efficacy and safety of catequentinib with placebo in patients with 131I-refractory differentiated thyroid cancer (ALTN01IIDTC; NCT02586337). The randomised, double-blind, trial was initiated in July 2015 and enrolled 113 patients in China [61] . In May 2019, enrolment in the trial was completed. In September 2020, efficacy and safety results from the trial were presented at the 45th European Society for Medical Oncology Congress (ESMO-2020) [62] .
In May 2019, the phase II/III ALTER01031 trial met its primary endpoint of progression-free survival. In September 2018, Jiangsu Chia-tai Tianqing Pharmaceutical completed the phase II/III ALTER01031 trial that compared the efficacy and safety of catequentinib with placebo in patients with medullary thyroid carcinoma (ALTN-01-IIMTC; NCT02586350). Progression free survival was evaluated as a primary endpoint in the study. The randomised, double-blind, parallel trial, initiated in July 2015, recruited 91 patients in China. In June 2019, efficacy and safety results from the trial were presented at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO-2019) [63] [64] . In May 2020, the company presented updated results from this trial at the 56th Annual Meeting of the American Society of Clinical Oncology (ASCO-2020) [65] [66] .
In September 2021, Chia Tai Tianqing Pharmaceutical initiated a phase II trial to evaluate the efficacy and safety of catequentinib (anlotinib hydrochloride) or penpulimab in combination with RAI (Sodium Iodide I 131) in patients with local advanced or metastatic differentiated thyroid cancer. (ALTER-T002; NCT04952493). A randomised, open-label, trial intends to enroll approximately 42 patients in China [67] .
In April 2013, Jiangsu Chia-tai Tianqing Pharmaceutical initiated the phase II ALTN/MTC trial to assess the safety and efficacy of catequentinib oral capsule in patients with advanced medullary thyroid carcinoma (ALTN-01-IIA; NCT01874873). The open-label trial enrolled 58 patients in China. The trial was completed in December 2016 [68] .
In June 2015, Jiangsu Chia-tai Tianging Pharmaceutical initiated the phase II/III ALTER0503 trial to compare the efficacy and safety of catequentinib versus placebo in patients with advanced gastric cancer (ALTN-05-II; NCT02461407). The randomised, double-blind trial is designed to enrol approximately 378 patients in China [69] .
Acral lentiginous melanoma
Chia Tai Tianqing Pharmaceutical, in June 2019, initiated a phase I/II trial to evaluate the safety and efficacy of APL 502 injection combined with catequentinib in patients with advanced acral lentiginous melanoma (TQB2450Ib09; NCT03991975). The open label trial intends to enrol approximately 42 patients in China [70] . In June 2022, efficacy and safety data from the trial was presented at the 58th Annual Meeting of the American Society of Clinical Oncology (ASCO-2022) [71] .
Other solid tumours
The US FDA granted orphan drug designation for catequentinib in the treatment of ovarian cancer in 2015 (NCT04106024).
In May 2023, Chia Tai Tianqing Pharmaceutical Group initiated a phase III trial to evaluate the efficacy of anlotinib hydrochloride capsules combined with penpulimab injection (test group) versus placebo (control group) for adjuvant therapy after radical surgery or ablation in HCC patients with high risk of recurrence by assessing recurrence-free survival (RFS) (NCT05862337; ALTN-AK105-III-06). This randomised, double-blind, placebo-controlled trial intends to enrol 480 patients in China [72] .
In May 2021, Chia Tai Tianqing Pharmaceutical initiated a phase III trial to evaluate the efficacy and safety of anlotinib hydrochloride and chemotherapy as a first line treatment in patients with RAS/BRAF wild type, unresectable metastatic colorectal cancer (ALTN8546;-02; ALTN-Ⅲ-02; NCT04854668). The randomised, open label trial will enrol approximately 698 participants in China [73] .
In September 2018, Jiangsu Chia-tai Tianqing Pharmaceutical initiated a phase III trial to compare catequentinib plus gemcitabine/cisplatin with placebo plus gemcitabine/cisplatin in previous untreated patients with recurrent/metastatic nasopharyngeal carcinoma, in order to verify the efficacy and security of catequentinib in metastatic nasopharyngeal carcinoma patients (NCT03601975; ALTN17III). The randomised trial is enrolling approximately 336 patients in China [74] .
In March 2019, Jiangsu Chia-tai Tianging Pharmaceutical completed the phase II/III ALTER0703 study that evaluated the safety and efficacy of catequentinib in patients with metastatic colorectal cancer, who progressed during or within 3 months following standard chemotherapies (ALTN-07-IIB; NCT02332499). The primary endpoint was the overall survival, assessed up to 24 months. The placebo controlled study, initiated in December 2014, enrolled 419 patients in China [75] .
In October 2021, Chia Tai Tianqing Pharmaceutical initiated a randomised phase II trial to compare the efficacy and safety of AK105 [See AdisInsigt drug profile 800050249] plus anlotinib and capecitabine/oxaliplatin (capeOx) , anlotinib plus CapeOx, bevacizumab Plus capeOx for the treatment of metastatic colorectal cancer (NCT05068206; ALTN-AK105-II-04). The open-label, multi-center trial intends to enroll approximately 120 patients in China.
In May 2020, Chia Tai Tianqing Pharmaceutical initiated a phase II trial to evaluate the combination of catequentinib and penpulimabin [see Adis Insight drug profile800050249] in patients with advanced head, neck and chest cancer (ALTN-AK105-II-01; NCT04203719). The open-label, single-arm, multi-cohort, multicenter study will enrol approximately 140 patients in China [76] . In June 2021, Chia Tai Tianqing Pharmaceutical presented the efficacy and safety data from the trial at the 57th Annual Meeting of the American Society of Clinical Oncology (ASCO-2021) [77] . In September 2022, updated efficacy and safety data from the trial at the 47th European Society for Medical Oncology Congress (ESMO-2022) [78] [79] . In June 2023, the company presented results from the cohort 2 of the study at the 59th Annual Meeting of the American Society of Clinical Oncology (ASCO-2023) [80] .
In June 2020, Chia Tai Tianqing Pharmaceutical initiated the phase II trial of catequentinib in combination with a penpulimabin [see Adis Insight drug profile800050249] for patients with cholangiocarcinoma, colorectal cancer, gastric cancer, urogenital cancer, neuroendocrine tumours (NCT04207463). Primary endpoint of the study is percentage of subjects achieving overall response rate (ORR). The open- label, single-arm study is designed to enroll 150 patients in China [81] . In September 2022, efficacy and safety data from the trial were presented at the 47th Annual Congress of the European Society for Medical Oncology (ESMO-2022) [82] .
Chia Tai Tianqing Pharmaceutical in March 2020, initiated a phase II trial of catequentinib in combination with niraparib [see Adis Insight drug profile800028881] in patients with platinum-resistant recurrent ovarian cancer, fallopian tube cancer, and primary peritoneal cancer. The open-label, single arm, non-randomised trial will recruit approximately 40 patients in China [83] .
In April 2020, Chia Tai Tianqing Pharmaceutical Group initiated a phase II ALTER-H-004 trial to evaluate the effects and safety of catequentinib hydrochloride combined with transcatheter arterial chemoembolization (TACE) in hepatocellular carcinoma (liver cancer) patients at high risk of post surgery recurrence (KYLLSL-2019-185; NCT04213118). The open label trial is enrolling approximately 48 patients in China [84] . The primary endpoint is defined as disease free survival (DFS). As of April 2020, two patients were enrolled in the study [85] . In June 2022, initial results from the trial were presented at the 58th Annual Meeting of the American Society of Clinical Oncology (ASCO-2022) [86] . In June 2023, updated results from this trial was presented at 59th Annual Meeting of the American Society of Clinical Oncology (ASCO-2023) [87]
In August 2023, Chia Tai Tianqing Pharmaceutical Group initiated a phase Ib trial to evaluate the safety and efficacy of TQB 2618 injection [see AdisInsight drug profile [800061155]] combined with penpulimab injection [see AdisInsight drug profile [800050249]] and anlotinib hydrochloride capsules for first-line treatment in patients with advanced hepatocellular carcinoma (NCT05975645; TQB2618-AK105-Ib-04). The open label, single-arm, multi-center trial intends to enroll 40 participants in China [ [88] ].
In November 2018, Akeso Biopharma initiated a phase II trial to evaluate the efficacy and safety of penpulimab [see Adis Insight drug profile800050249] plus anlotinib hydrochloride in the first-line treatment of patients with unresectable hepatocellular carcinoma (NCT04172571; AK105-203). The open-label trial is enrolling approximately 31 patients in China [89] . As of Jan 2020, 31 patients received combined therapy. In May 2020, the company presented results from this trial at the 56th Annual Meeting of the American Society of Clinical Oncology (ASCO-2020) [90] .
In March 2019, Chia Tai Tianqing Pharmaceutical initiated a phase II trial of catequentinib in patients with platinum-resistant or refractory high grade serous adenocarcinoma of ovarian, fallopian tube and peritoneum (1903198-19; OVA-2019-1; ChiCTR2000029654). The trial will recruit approximately 41 patients in China. In June 2021, safety and efficacy data from the trial were presented at the 57th Annual Meeting of the American Society of Clinical Oncology (ASCO-2021) [91] [92] [93] . In September 2021, results from the trial were presented at the 46th European Society for Medical Oncology Congress (ESMO-2021) [94] .
In January 2018, Chia-tai Tianqing Pharmaceutical initiated a phase II trial to evaluate the efficacy and safety of catequentinib, for the treatment of patients with gastroenteropancreatic neuroendocrine tumour G3 (ALTN-13-II; NCT03457844). The single group, open Label, multi-center study is intended to enrol approximately 60 patients in China [95] .
In January 2018, Chia-tai Tianqing Pharmaceutical initiated a phase II trial to evaluate the safety and efficacy of catequentinib hydrochloride capsule in patients with primary malignant bone tumors with recurrence and distant metastases (NCT03527888; ALTN-15-II). The open label trial intends to enrol approximately 40 patients in China. In May 2020, results from the trial were presented at 56th Annual Meeting of the American Society of Clinical Oncology(ASCO-2020). Results showed promising activity of catequentinib in patients with relapsed or metastatic primary malignant bone tumor and an acceptable toxicity [96] [97] .
Small cell lung cancer
In December 2020, Chia-tai Tianqing Pharmaceutical initiated a phase II trial to investigate the effectiveness and safety of anlotinib in combination with penpulimab [see AdisInsight drug profile 800050249] in patients with sensitive relapsed small-cell lung cancer (NCT05001971; ALTER-L041). The open label trial intends to enroll 73 patients in China [98] . In June 2023, efficacy and adverse events data were presented at the 59th Annual Meeting of the American Society of Clinical Oncology (ASCO-2023) [99] .
In May 2019, Jiangsu Chia-tai Tianqing Pharmaceutical completed the phase II ALTER1202 trial which evaluated the efficacy and safety, of catequentinib, in patients with advanced small cell lung cancer (ALTN-12-II; NCT03059797). The randomised, double-blind, placebo-controlled trial initiated in March 2017, enrolled 120 patients in China. In the trial no new adverse events were observed. In September 2019, efficacy results from the trial were presented at the 44th European Society for Medical Oncology Congress (ESMO-2019) [100] [101] . In September 2020, efficacy and adverse event results from the trial were presented at the 45th European Society for Medical Oncology Congress (ESMO-2020) [102] .
Prior to June 2021, Tianquan Pharmaceutical completed a phase II trial in patients with small-cell lung cancer (ChiCTR2000035043). Earlier in January 2019, Tianquan Pharmaceutical initiated the phase II trial to assess anlotinib combined with etoposide plus cisplatin/carboplatin as first-line therapy in patients with extensive-stage small cell lung cancer (SCLC). The trial enrolled 20 patients in China [103] [104] .
In September 2016, Jiangsu Chia-tai Tianqing Pharmaceutical initiated the phase II ALTER0802 trial to assess the efficacy and safety of catequentinib, as compared with placebo, in patients with hepatocellular carcinoma (ALTN-08-II; NCT02809534). The single-group, open-label trial will enrol approximately 60 patients in China. In September 2019, results from the study were presented at the 44th European Society for Medical Oncology Congress (ESMO-2019) [105] [106] .
In December 2013, Jiangsu Chia-tai Tianqing Pharmaceutical initiated a phase II clinical trial of catequentinib in patients with advanced renal cell carcinoma that have failed or are intolerant to TKIs therapy (ALTN-06-IIB; NCT02072044). The open-label trial is enrolled 60 patients in China [107] .
Also, in December 2013, Jiangsu Chia-tai Tianqing Pharmaceutical initiated a randomised, open-label phase II trial to assess the efficacy and safety of catequentinib, compared to sunitinib, in patients with advanced renal cell carcinoma (ALTN-06-IIA; NCT02072031). The trial is enrolling previously untreated patients, as well as patients that have failed or are resistant to chemotherapy/cytokine therapy. Approximately 180 patients will be enrolled in China [108] .
In August 2015, Chia Tai Tianqing Pharmaceutical Group Co. initiated a phase II trial to evaluate the efficacy and safety of catequentinib in patients with advanced malignancy (NCT04216082; ALTN-00-II). The open-label trial was initiated in August 2013, and enrolled 93 patients in China [109] .
In February 2020, Chia Tai Tianqing Pharmaceutical initiated a phase I/II trial of TQB 2450 [see Adis Insight drug profile 800053691] combined with catequentinib in patients with relapsed or refractory epithelial ovarian, fallopian tube, or primary peritoneal cancer (NCT04236362; TQB2450-Ib-10). The open-label trial is designed to enrol approximately 30 participants in China [110] . In June 2021, efficacy and safety results were presented at the 57th Annual Meeting of the American Society of Clinical Oncology (ASCO-2021) [111]
In June 2019, Advenchen Laboratories terminated a two-part phase Ib/IIa trial that intended to investigate the safety, pharmacokinetics and efficacy of catequentinib in female patients with recurrent or metastatic endometrial, ovarian or cervical cancer (AL3818-US-001; NCT02558348). The open-label trial was initiated in November 2015 and enrolled 12 patients in the US [112] . Advenchen Laboratories in June 2017, presented safety and pharmacokinetics data of one patient with ovarian and two patients with endometrium cancer at the 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO-2017) [113] .
Advenchen Laboratories, in December 2015, initiated the phase Ib/IIa AL3818 trial to evaluate the safety and efficacy of adding oral catequentinib to standard platinum-based chemotherapy such as carboplatin plus paclitaxel, concurrently and continued as a maintenance therapy for up to 12 months, in female patients with recurrent or metastatic endometrial, ovarian, fallopian, primary peritoneal or cervical carcinoma (AL3818-US-002; NCT02584478). The primary endpoint of phase Ib part of the study will be to determine the recommended phase II dose through the evaluation of DLT events and phase IIa part will evaluate the objective response rates. The open-label, single-group trial will recruit 48 patients in the US [114] .
In June 2019, Chia Tai Tianqing Pharmaceutical Group initiated a phase I trial to evaluate TQB 2450 [see AdisInsight drug profile800053691] combined with anlotinib in patients with advanced solid tumors (TQB2450-Ib-04; NCT03897283). The open-label trial intends to enrol approximately 22 patients in China [115] .
In August 2018, Jiangsu Chia-tai Tianqing Pharmaceutical initiated a phase I trial to assess the pharmacokinetics of catequentinib in patients with advanced solid tumours with high fat diet (ALTN-I-05; NCT02825563). The open-label, randomised trial initiated in June 2016, enrolled 22 patients in China [116] .
Jiangsu Chia-tai Tianqing Pharmaceutical initiated a phase I trial to assess the tolerance, pharmacokinetics and pharmacodynamics of catequentinib in patients with advanced solid tumours (ALTN-I-07; NCT02752516). The open-label, single-group trial enrolled 16 patients in China [117] .
In August 2017, Jiangsu Chia-tai Tianqing Pharmaceutical completed a phase I pharmacokinetics study which investigated the absorption, metabolism and excretion of [14C]-catequentinib in advanced cancer patients (ALTN-I-R; NCT02622932). The open-label trial that was initiated in December 2015 enrolled six patients in China [118] .
Jiangsu Chia-tai Tianqing Pharmaceutical initiated an open-label, interventional phase I clinical trial in May 2011, to assess the pharmacokinetics and tolerability, and to determine the maximum tolerated dose, dose-limiting toxicity and dosage regimen for phase II trials of catequentinib (ALTN; ALTN-I-01; NCT01833923). The trial enrolled 35 patients with advanced cancer in China, and was completed in October 2015 [119] .
Drug Properties & Chemical Synopsis
- Route of administration PO
- Formulation Capsule, unspecified
- Class Amines, Antineoplastics, Cyclopropanes, Ethers, Fluorinated hydrocarbons, Indoles, Quinolines, Small molecules
- Target Fibroblast growth factor receptor; Platelet-derived growth factor beta receptor; Proto oncogene protein c-kit; Vascular endothelial growth factor receptor 3; Vascular endothelial growth factor receptor-1; Vascular endothelial growth factor receptor-2
- Mechanism of Action Fibroblast growth factor receptor antagonists; Platelet-derived growth factor beta receptor antagonists; Proto oncogene protein c-kit inhibitors; Vascular endothelial growth factor receptor 3 antagonists; Vascular endothelial growth factor receptor-1 antagonists; Vascular endothelial growth factor receptor-2 antagonists
-
WHO ATC code
L01X-E (Protein kinase inhibitors)
-
EPhMRA code
L1H (Protein Kinase Inhibitor Antineoplastics)
L1X (All Other Antineoplastics)
- Chemical name 1-[[4-[(4-fluoro-2-methyl-1H-indol-5-yl)oxy]-6-methoxyquinolin-7-yl]oxymethyl]cyclopropan-1-amine
- Molecular formula C23 H22 F N3O3
- SMILES C1(CC1)(N)COC1=C(C=C2C(=CC=NC2=C1)OC1=C(C2C=C(NC=2C=C1)C)F)OC
- Chemical Structure
- CAS Registry Number 1058156-90-3
Biomarkers Sourced From Trials
Indication | Biomarker Function | Biomarker Name | Number of Trials |
---|---|---|---|
adenocarcinoma |
Outcome Measure |
Fibroblast Growth Factor (FGF2) CD95 (APO-1/Fas) |
|
adenocarcinoma |
Brief Title |
PD-L1/CD274 Epidermal growth factor receptor (EGFR) BRAF |
|
adenocarcinoma |
Arm Group Description |
PD-L1/CD274 |
|
adenocarcinoma |
Detailed Description |
HER2/ERBB2 Epidermal growth factor receptor (EGFR) C-Kit |
|
adenocarcinoma |
Eligibility Criteria |
tumor necrosis factor receptor superfamily, member 4 tumor necrosis factor receptor superfamily member 9 SERPINA2 ROS1 ring finger protein 2 RAS RAD51 PD-L2 PD-L1/CD274 PD-1/CD279 partner and localizer of BRCA2 PARP-1 Oxalacetic acid N-acylethanolamine acid amidase Microsatellite Instable (MSI) methylmalonic aciduria (cobalamin deficiency) cblB type membrane associated guanylate kinase, WW and PDZ domain containing 1 Luteinizing hormone (LH) Hydrocortisone HER2/ERBB2 FANCA Epidermal growth factor receptor (EGFR) cytotoxic T-lymphocyte-associated protein 4 Creatinine collagen, type XI, alpha 2 CHK2 BRCA2 BRCA1 interacting protein C-terminal helicase 1 BRCA1 BRAF BAP1 ATR Ataxia telangiectasia mutated anthrax toxin receptor 1 Anaplastic lymphoma receptor tyrosine kinase (ALP) ALT |
|
adenocarcinoma |
Official Title |
RET PD-L1/CD274 Epidermal growth factor receptor (EGFR) BRAF |
|
adenocarcinoma |
Brief Summary |
RAS Epidermal growth factor receptor (EGFR) C-Kit BRAF |
|
adenosquamous carcinoma |
Eligibility Criteria |
tumor necrosis factor receptor superfamily, member 4 tumor necrosis factor receptor superfamily member 9 PD-L1/CD274 PARP-1 cytotoxic T-lymphocyte-associated protein 4 collagen, type XI, alpha 2 |
|
adenosquamous carcinoma |
Official Title |
RET |
|
advanced breast cancer |
Outcome Measure |
PD-L1/CD274 |
|
advanced breast cancer |
Brief Title |
HER2/ERBB2 Fibroblast growth factor receptor 2 (FGFR2) Fibroblast growth factor receptor 1 (FGFR1) |
|
advanced breast cancer |
Detailed Description |
HER2/ERBB2 Fibroblast growth factor receptor 2 (FGFR2) Fibroblast growth factor receptor 1 (FGFR1) |
|
advanced breast cancer |
Eligibility Criteria |
SERPINA2 ring finger protein 2 RAD51 Progesterone partner and localizer of BRCA2 N-acylethanolamine acid amidase methylmalonic aciduria (cobalamin deficiency) cblB type membrane associated guanylate kinase, WW and PDZ domain containing 1 L-Aspartic acid HER2/ERBB2 Fibroblast growth factor receptor 2 (FGFR2) Fibroblast growth factor receptor 1 (FGFR1) FANCA Estrogen receptor alpha (ER alpha) cytokine inducible SH2-containing protein CHK2 BRCA2 BRCA1 interacting protein C-terminal helicase 1 BRCA1 Bilirubin BAP1 ATR Ataxia telangiectasia mutated anthrax toxin receptor 1 ALT |
|
advanced breast cancer |
Official Title |
HER2/ERBB2 Fibroblast growth factor receptor 2 (FGFR2) Fibroblast growth factor receptor 1 (FGFR1) |
|
advanced breast cancer |
Brief Summary |
PD-L1/CD274 HER2/ERBB2 Fibroblast growth factor receptor 2 (FGFR2) Fibroblast growth factor receptor 1 (FGFR1) |
|
alveolar soft part sarcoma |
Brief Summary |
FLT4 |
|
alveolar soft part sarcoma |
Eligibility Criteria |
p63 Alkaline phosphatase (ALPL) |
|
anaplastic astrocytoma |
Detailed Description |
Fibroblast growth factor receptor 1 (FGFR1) |
|
biliary cancer |
Eligibility Criteria |
Oxalacetic acid N-acylethanolamine acid amidase Creatinine ALT |
|
bladder cancer |
Eligibility Criteria |
HER2/ERBB2 |
|
brain metastases |
Brief Title |
Epidermal growth factor receptor (EGFR) |
|
brain metastases |
Detailed Description |
Fibroblast growth factor receptor 1 (FGFR1) |
|
brain metastases |
Eligibility Criteria |
ROS1 Mannitol Epidermal growth factor receptor (EGFR) Anaplastic lymphoma receptor tyrosine kinase (ALP) |
|
brain metastases |
Official Title |
Epidermal growth factor receptor (EGFR) |
|
brain metastases |
Brief Summary |
Epidermal growth factor receptor (EGFR) |
|
cancer |
Brief Summary |
FLT4 |
|
carcinoma |
Outcome Measure |
Fibroblast Growth Factor (FGF2) Alpha-fetoprotein (AFP) |
|
carcinoma |
Brief Title |
BRAF |
|
carcinoma |
Detailed Description |
RAS BRAF |
|
carcinoma |
Eligibility Criteria |
Thyroxine (T4) Thyroid stimulating hormone beta (TSH) RAS PGR PD-L2 PD-1/CD279 PARP-1 Luteinizing hormone (LH) HER2/ERBB2 FSH Estrogen receptor alpha (ER alpha) cytotoxic T-lymphocyte-associated protein 4 collagen, type XI, alpha 2 BRAF Adenosine diphosphate ribose |
|
carcinoma |
Official Title |
RET BRAF |
|
carcinoma |
Brief Summary |
RAS BRAF |
|
cervical cancer |
Eligibility Criteria |
tumor necrosis factor receptor superfamily, member 4 tumor necrosis factor receptor superfamily member 9 PD-L2 PD-L1/CD274 PD-1/CD279 PARP-1 cytotoxic T-lymphocyte-associated protein 4 collagen, type XI, alpha 2 |
|
cervical cancer |
Official Title |
RET |
|
cervical cancer |
Outcome Measure |
Fibroblast Growth Factor (FGF2) |
|
cholangiocarcinoma |
Detailed Description |
HER2/ERBB2 |
|
cholangiocarcinoma |
Eligibility Criteria |
SERPINA2 ring finger protein 2 RAD51 partner and localizer of BRCA2 Oxalacetic acid N-acylethanolamine acid amidase methylmalonic aciduria (cobalamin deficiency) cblB type membrane associated guanylate kinase, WW and PDZ domain containing 1 HER2/ERBB2 FANCA Creatinine CHK2 BRCA2 BRCA1 interacting protein C-terminal helicase 1 BRCA1 BAP1 ATR Ataxia telangiectasia mutated anthrax toxin receptor 1 ALT |
|
cholangiocarcinoma |
Official Title |
PD-L1/CD274 |
|
chondrosarcoma |
Brief Summary |
IDH2 IDH1 |
|
chondrosarcoma |
Detailed Description |
IDH2 IDH1 |
|
chondrosarcoma |
Eligibility Criteria |
Thyroid stimulating hormone beta (TSH) CYP3A4 |
|
Chordoma |
Brief Title |
Chordoma |
|
Chordoma |
Official Title |
Chordoma |
|
clear cell sarcoma |
Brief Summary |
FLT4 |
|
colon cancer |
Brief Title |
BRAF |
|
colon cancer |
Detailed Description |
RAS BRAF |
|
colon cancer |
Eligibility Criteria |
RAS BRAF |
|
colon cancer |
Official Title |
BRAF |
|
colon cancer |
Brief Summary |
RAS BRAF |
|
colorectal cancer |
Outcome Measure |
Interleukin-6 (IL-6) |
|
colorectal cancer |
Brief Title |
BRAF |
|
colorectal cancer |
Detailed Description |
RAS BRAF |
|
colorectal cancer |
Eligibility Criteria |
RAS PD-L1/CD274 PD-1/CD279 Microsatellite Instable (MSI) Hydrocortisone HER2/ERBB2 cytotoxic T-lymphocyte-associated protein 4 BRAF |
|
colorectal cancer |
Official Title |
PD-L1/CD274 BRAF |
|
colorectal cancer |
Brief Summary |
RAS BRAF |
|
diffuse large B cell lymphoma |
Arm Group Description |
RET |
|
early breast cancer |
Eligibility Criteria |
PGR HER2/ERBB2 Estrogen receptor alpha (ER alpha) |
|
endometrial cancer |
Eligibility Criteria |
PD-L2 PD-1/CD279 PARP-1 Microsatellite Instable (MSI) mannose receptor, C type 1 cytotoxic T-lymphocyte-associated protein 4 collagen, type XI, alpha 2 |
|
endometrial cancer |
Official Title |
RET |
|
endometrial cancer |
Outcome Measure |
Fibroblast Growth Factor (FGF2) |
|
Ewing's sarcoma |
Eligibility Criteria |
CALCA |
|
Extranodal NK-T-cell lymphoma |
Eligibility Criteria |
Fibrinogen |
|
fallopian tube cancer |
Eligibility Criteria |
Thyroxine (T4) Thyroid stimulating hormone beta (TSH) Prothrombin (PT) PD-L2 PD-1/CD279 PARP-1 Estrogen receptor alpha (ER alpha) cytotoxic T-lymphocyte-associated protein 4 collagen, type XI, alpha 2 CA125 ovarian cancer antigen (MUC16) |
|
fallopian tube cancer |
Official Title |
RET |
|
fallopian tube cancer |
Outcome Measure |
Fibroblast Growth Factor (FGF2) |
|
gallbladder cancer |
Eligibility Criteria |
Oxalacetic acid N-acylethanolamine acid amidase Creatinine ALT |
|
gallbladder cancer |
Official Title |
PD-L1/CD274 |
|
gastric cancer |
Brief Title |
PD-L1/CD274 |
|
gastric cancer |
Arm Group Description |
PD-L1/CD274 |
|
gastric cancer |
Detailed Description |
HER2/ERBB2 |
|
gastric cancer |
Eligibility Criteria |
SERPINA2 ring finger protein 2 RAD51 PD-L1/CD274 partner and localizer of BRCA2 Microsatellite Instable (MSI) methylmalonic aciduria (cobalamin deficiency) cblB type membrane associated guanylate kinase, WW and PDZ domain containing 1 Hydrocortisone HER2/ERBB2 FANCA CHK2 BRCA2 BRCA1 interacting protein C-terminal helicase 1 BRCA1 BAP1 ATR Ataxia telangiectasia mutated anthrax toxin receptor 1 |
|
gastric cancer |
Official Title |
PD-L1/CD274 |
|
gastrointestinal cancer |
Eligibility Criteria |
PD-L1/CD274 Nuclear protein Ki67 Microsatellite Instable (MSI) Hydrocortisone HER2/ERBB2 |
|
gastrointestinal cancer |
Official Title |
PD-L1/CD274 |
|
gastrointestinal stromal tumours |
Brief Summary |
PDGFRA |
|
glioblastoma |
Brief Title |
MGMT |
|
glioblastoma |
Arm Group Description |
MGMT |
|
glioblastoma |
Detailed Description |
VEGFR PDGFRB PDGFRA MGMT Fibroblast growth factor receptor 1 (FGFR1) |
|
glioblastoma |
Eligibility Criteria |
VEGFR PDGFRB PDGFRA MGMT IDH1 Fibroblast growth factor receptor 1 (FGFR1) |
|
glioblastoma |
Official Title |
MGMT |
|
glioblastoma |
Brief Summary |
VEGFR PDGFRB PDGFRA MGMT Fibroblast growth factor receptor 1 (FGFR1) |
|
glioma |
Detailed Description |
Fibroblast growth factor receptor 1 (FGFR1) |
|
gynaecological cancer |
Eligibility Criteria |
PD-L2 PD-1/CD279 Microsatellite Instable (MSI) mannose receptor, C type 1 cytotoxic T-lymphocyte-associated protein 4 |
|
hER2 negative breast cancer |
Brief Title |
HER2/ERBB2 |
|
hER2 negative breast cancer |
Detailed Description |
HER2/ERBB2 |
|
hER2 negative breast cancer |
Eligibility Criteria |
SERPINA2 ring finger protein 2 RAD51 partner and localizer of BRCA2 N-acylethanolamine acid amidase methylmalonic aciduria (cobalamin deficiency) cblB type membrane associated guanylate kinase, WW and PDZ domain containing 1 L-Aspartic acid HER2/ERBB2 FANCA cytokine inducible SH2-containing protein CHK2 BRCA2 BRCA1 interacting protein C-terminal helicase 1 BRCA1 Bilirubin BAP1 ATR Ataxia telangiectasia mutated anthrax toxin receptor 1 ALT |
|
hER2 negative breast cancer |
Official Title |
HER2/ERBB2 |
|
hER2 negative breast cancer |
Brief Summary |
HER2/ERBB2 |
|
leiomyosarcoma |
Brief Summary |
FLT4 |
|
leiomyosarcoma |
Eligibility Criteria |
p63 Alkaline phosphatase (ALPL) |
|
liposarcoma |
Brief Summary |
FLT4 |
|
liver cancer |
Arm Group Label |
ADAM metallopeptidase domain 17 |
|
liver cancer |
Outcome Measure |
Alpha-fetoprotein (AFP) |
|
liver cancer |
Brief Title |
ADAM metallopeptidase domain 17 |
|
liver cancer |
Arm Group Description |
ADAM metallopeptidase domain 17 |
|
liver cancer |
Eligibility Criteria |
Thyroid stimulating hormone beta (TSH) Prothrombin (PT) Oxalacetic acid N-acylethanolamine acid amidase Fibrinogen Creatinine ALT Alpha-fetoprotein (AFP) ADAM metallopeptidase domain 17 |
|
liver cancer |
Official Title |
ADAM metallopeptidase domain 17 |
|
liver metastases |
Brief Title |
BRAF |
|
liver metastases |
Detailed Description |
RAS BRAF |
|
liver metastases |
Eligibility Criteria |
RAS Epidermal growth factor receptor (EGFR) BRAF Anaplastic lymphoma receptor tyrosine kinase (ALP) |
|
liver metastases |
Official Title |
BRAF |
|
liver metastases |
Brief Summary |
RAS BRAF |
|
male breast cancer |
Detailed Description |
HER2/ERBB2 |
|
male breast cancer |
Eligibility Criteria |
SERPINA2 ring finger protein 2 RAD51 Progesterone partner and localizer of BRCA2 methylmalonic aciduria (cobalamin deficiency) cblB type membrane associated guanylate kinase, WW and PDZ domain containing 1 HER2/ERBB2 FANCA CHK2 BRCA2 BRCA1 interacting protein C-terminal helicase 1 BRCA1 BAP1 ATR Ataxia telangiectasia mutated anthrax toxin receptor 1 |
|
malignant fibrous histiocytoma |
Brief Summary |
FLT4 |
|
malignant fibrous histiocytoma |
Outcome Measure |
T-cell surface antigen CD4 T-cell receptor T3 delta chain (CD3d) T-cell receptor CD3-epsilon (CD3e) T-Cell differentiation antigen CD8 PD-L2 PD-L1/CD274 PD-1/CD279 Nuclear protein Ki67 LAG-3 (CD223) HAVCR2 (TIM-3) cytotoxic T-lymphocyte-associated protein 4 CD3 gamma chain (CD3G) |
|
malignant melanoma |
Official Title |
PD-L1/CD274 PD-1/CD279 |
|
myxoid liposarcoma |
Eligibility Criteria |
Alkaline phosphatase (ALPL) |
|
nasopharyngeal cancer |
Eligibility Criteria |
Thyroxine (T4) Thyroid stimulating hormone beta (TSH) |
|
neuroblastoma |
Brief Summary |
N-Myc |
|
neuroendocrine tumours |
Eligibility Criteria |
Nuclear protein Ki67 HER2/ERBB2 |
|
neurofibrosarcoma |
Eligibility Criteria |
Alkaline phosphatase (ALPL) |
|
non-small cell lung cancer |
Arm Group Label |
Epidermal growth factor receptor (EGFR) |
|
non-small cell lung cancer |
Outcome Measure |
Tumor Mutational Burden PD-L1/CD274 Epidermal growth factor receptor (EGFR) |
|
non-small cell lung cancer |
Brief Title |
ROS1 PD-L1/CD274 KRAS Epidermal growth factor receptor (EGFR) |
|
non-small cell lung cancer |
Arm Group Description |
Epidermal growth factor receptor (EGFR) COL18A1 Alkaline phosphatase (ALPL) |
|
non-small cell lung cancer |
Detailed Description |
ROS1 Fibroblast growth factor receptor 1 (FGFR1) Epidermal growth factor receptor (EGFR) C-Kit Anaplastic lymphoma receptor tyrosine kinase (ALP) |
|
non-small cell lung cancer |
Eligibility Criteria |
Thyroid stimulating hormone beta (TSH) T-cell surface antigen CD4 ROS1 pregnancy specific beta-1-glycoprotein 2 PD-L1/CD274 PD-1/CD279 Mannitol Luteinizing hormone (LH) KRAS FSH Epidermal growth factor receptor (EGFR) Cytokeratin 18 CEA carcinoembryonic antigen related cell adhesion molecule 3 BRAF Anaplastic lymphoma receptor tyrosine kinase (ALP) |
|
non-small cell lung cancer |
Official Title |
ROS1 PD-L1/CD274 KRAS Epidermal growth factor receptor (EGFR) cytotoxic T-lymphocyte-associated protein 4 |
|
non-small cell lung cancer |
Brief Summary |
VEGFR Tumor Mutational Burden ROS1 PLK3 PDGFRB PDGFRA PD-L1/CD274 Fibroblast growth factor receptor 4 (FGFR4) Fibroblast growth factor receptor 3 (FGFR3) Fibroblast growth factor receptor 2 (FGFR2) Fibroblast growth factor receptor 1 (FGFR1) Fibroblast Growth Factor (FGF2) Epidermal growth factor receptor (EGFR) C-Kit BRAF Anaplastic lymphoma receptor tyrosine kinase (ALP) |
|
oesophageal cancer |
Arm Group Description |
PD-L1/CD274 |
|
oesophageal cancer |
Brief Title |
PD-L1/CD274 |
|
oesophageal cancer |
Eligibility Criteria |
PD-L1/CD274 N-acylethanolamine acid amidase Microsatellite Instable (MSI) Luteinizing hormone (LH) Hydrocortisone HER2/ERBB2 FSH Bilirubin |
|
oesophageal cancer |
Official Title |
PD-L1/CD274 |
|
oligodendroglioma |
Detailed Description |
Fibroblast growth factor receptor 1 (FGFR1) |
|
ovarian cancer |
Eligibility Criteria |
Thyroxine (T4) Thyroid stimulating hormone beta (TSH) Prothrombin (PT) PD-L2 PD-1/CD279 PARP-1 Estrogen receptor alpha (ER alpha) cytotoxic T-lymphocyte-associated protein 4 collagen, type XI, alpha 2 CA125 ovarian cancer antigen (MUC16) Adenosine diphosphate ribose |
|
ovarian cancer |
Official Title |
RET |
|
ovarian cancer |
Outcome Measure |
Fibroblast Growth Factor (FGF2) |
|
pancreatic cancer |
Detailed Description |
HER2/ERBB2 |
|
pancreatic cancer |
Eligibility Criteria |
SERPINA2 ring finger protein 2 RAD51 partner and localizer of BRCA2 Nuclear protein Ki67 methylmalonic aciduria (cobalamin deficiency) cblB type membrane associated guanylate kinase, WW and PDZ domain containing 1 HER2/ERBB2 FANCA CHK2 BRCA2 BRCA1 interacting protein C-terminal helicase 1 BRCA1 BAP1 ATR Ataxia telangiectasia mutated anthrax toxin receptor 1 |
|
paraganglioma |
Eligibility Criteria |
von Hippel-Lindau tumor suppressor, E3 ubiquitin protein ligase |
|
peripheral T-cell lymphoma |
Arm Group Description |
RET |
|
peritoneal cancer |
Eligibility Criteria |
Thyroxine (T4) Thyroid stimulating hormone beta (TSH) Prothrombin (PT) PD-L2 PD-1/CD279 PARP-1 Estrogen receptor alpha (ER alpha) cytotoxic T-lymphocyte-associated protein 4 collagen, type XI, alpha 2 CA125 ovarian cancer antigen (MUC16) |
|
peritoneal cancer |
Official Title |
RET |
|
peritoneal cancer |
Outcome Measure |
Fibroblast Growth Factor (FGF2) |
|
Phaeochromocytoma |
Eligibility Criteria |
von Hippel-Lindau tumor suppressor, E3 ubiquitin protein ligase |
|
rectal cancer |
Outcome Measure |
CD95 (APO-1/Fas) |
|
rectal cancer |
Brief Title |
BRAF |
|
rectal cancer |
Detailed Description |
RAS BRAF |
|
rectal cancer |
Eligibility Criteria |
RAS BRAF |
|
rectal cancer |
Official Title |
BRAF |
|
rectal cancer |
Brief Summary |
RAS BRAF |
|
renal cancer |
Eligibility Criteria |
HER2/ERBB2 |
|
renal cell carcinoma |
Arm Group Label |
Maleic acid |
|
sarcoma |
Eligibility Criteria |
Alkaline phosphatase (ALPL) |
|
small cell lung cancer |
Brief Summary |
C-Kit |
|
small cell lung cancer |
Detailed Description |
Fibroblast growth factor receptor 1 (FGFR1) |
|
small cell lung cancer |
Eligibility Criteria |
T-cell surface antigen CD4 Luteinizing hormone (LH) FSH Epidermal growth factor receptor (EGFR) Anaplastic lymphoma receptor tyrosine kinase (ALP) |
|
soft tissue sarcoma |
Brief Summary |
FLT4 |
|
soft tissue sarcoma |
Eligibility Criteria |
T-cell surface antigen CD4 p63 Alkaline phosphatase (ALPL) |
|
solid tumours |
Arm Group Label |
PD-L1/CD274 Fibroblast growth factor receptor 4 (FGFR4) Fibroblast growth factor receptor 3 (FGFR3) Fibroblast growth factor receptor 2 (FGFR2) Fibroblast growth factor receptor 1 (FGFR1) |
|
solid tumours |
Brief Title |
Microsatellite Instable (MSI) Fibroblast growth factor receptor 4 (FGFR4) Fibroblast growth factor receptor 3 (FGFR3) Fibroblast growth factor receptor 2 (FGFR2) Fibroblast growth factor receptor 1 (FGFR1) |
|
solid tumours |
Detailed Description |
HER2/ERBB2 |
|
solid tumours |
Eligibility Criteria |
T-cell surface antigen CD4 SERPINA2 ring finger protein 2 RAD51 partner and localizer of BRCA2 methylmalonic aciduria (cobalamin deficiency) cblB type membrane associated guanylate kinase, WW and PDZ domain containing 1 HER2/ERBB2 Fibroblast growth factor receptor 4 (FGFR4) Fibroblast growth factor receptor 3 (FGFR3) Fibroblast growth factor receptor 2 (FGFR2) Fibroblast growth factor receptor 1 (FGFR1) FANCA CHK2 BRCA2 BRCA1 interacting protein C-terminal helicase 1 BRCA1 BAP1 ATR Ataxia telangiectasia mutated anthrax toxin receptor 1 |
|
solid tumours |
Official Title |
PD-L1/CD274 Microsatellite Instable (MSI) Fibroblast growth factor receptor 4 (FGFR4) Fibroblast growth factor receptor 3 (FGFR3) Fibroblast growth factor receptor 2 (FGFR2) Fibroblast growth factor receptor 1 (FGFR1) |
|
solid tumours |
Brief Summary |
Fibroblast growth factor receptor 4 (FGFR4) Fibroblast growth factor receptor 3 (FGFR3) Fibroblast growth factor receptor 2 (FGFR2) Fibroblast growth factor receptor 1 (FGFR1) |
|
squamous cell cancer |
Brief Title |
PD-L1/CD274 |
|
squamous cell cancer |
Detailed Description |
Epidermal growth factor receptor (EGFR) |
|
squamous cell cancer |
Eligibility Criteria |
tumor necrosis factor receptor superfamily, member 4 tumor necrosis factor receptor superfamily member 9 ROS1 PD-L2 PD-L1/CD274 PD-1/CD279 PARP-1 N-acylethanolamine acid amidase Luteinizing hormone (LH) FSH Epidermal growth factor receptor (EGFR) cytotoxic T-lymphocyte-associated protein 4 collagen, type XI, alpha 2 Bilirubin Anaplastic lymphoma receptor tyrosine kinase (ALP) |
|
squamous cell cancer |
Official Title |
RET PD-L1/CD274 |
|
squamous cell cancer |
Brief Summary |
Epidermal growth factor receptor (EGFR) C-Kit |
|
synovial sarcoma |
Brief Summary |
FLT4 |
|
synovial sarcoma |
Eligibility Criteria |
p63 Alkaline phosphatase (ALPL) |
|
T-cell lymphoma |
Eligibility Criteria |
Fibrinogen Creatinine Bilirubin ALT |
|
T-cell lymphoma |
Official Title |
ASRGL1 |
|
thyroid cancer |
Brief Summary |
FLT4 |
|
triple negative breast cancer |
Brief Summary |
PD-L1/CD274 |
|
triple negative breast cancer |
Eligibility Criteria |
Progesterone PGR HER2/ERBB2 Estrogen receptor alpha (ER alpha) |
|
triple negative breast cancer |
Outcome Measure |
PD-L1/CD274 |
|
ureteral neoplasms |
Eligibility Criteria |
HER2/ERBB2 |
|
urogenital cancer |
Eligibility Criteria |
HER2/ERBB2 |
|
uterine cancer |
Eligibility Criteria |
PARP-1 collagen, type XI, alpha 2 |
|
uterine cancer |
Official Title |
RET |
Biomarker
Drug Name | Biomarker Name | Biomarker Function |
---|---|---|
Catequentinib - Advenchen Laboratories/Jiangsu Chia Tai Tianqing Pharmaceutical | ADAM metallopeptidase domain 17 | Arm Group Description, Arm Group Label, Brief Title, Eligibility Criteria, Official Title |
Adenosine diphosphate ribose | Eligibility Criteria | |
Alkaline phosphatase (ALPL) | Arm Group Description, Eligibility Criteria | |
Alpha-fetoprotein (AFP) | Eligibility Criteria, Outcome Measure | |
ALT | Eligibility Criteria | |
Anaplastic lymphoma receptor tyrosine kinase (ALP) | Brief Summary, Detailed Description, Eligibility Criteria | |
anthrax toxin receptor 1 | Eligibility Criteria | |
ASRGL1 | Official Title | |
Ataxia telangiectasia mutated | Eligibility Criteria | |
ATR | Eligibility Criteria | |
BAP1 | Eligibility Criteria | |
Bilirubin | Eligibility Criteria | |
BRAF | Brief Summary, Brief Title, Detailed Description, Eligibility Criteria, Official Title | |
BRCA1 | Eligibility Criteria | |
BRCA1 interacting protein C-terminal helicase 1 | Eligibility Criteria | |
BRCA2 | Eligibility Criteria | |
C-Kit | Brief Summary, Detailed Description | |
CA125 ovarian cancer antigen (MUC16) | Eligibility Criteria | |
CALCA | Eligibility Criteria | |
carcinoembryonic antigen related cell adhesion molecule 3 | Eligibility Criteria | |
CD3 gamma chain (CD3G) | Outcome Measure | |
CD95 (APO-1/Fas) | Outcome Measure | |
CEA | Eligibility Criteria | |
CHK2 | Eligibility Criteria | |
Chordoma | Brief Title, Official Title | |
COL18A1 | Arm Group Description | |
collagen, type XI, alpha 2 | Eligibility Criteria | |
Creatine | Eligibility Criteria | |
Creatinine | Eligibility Criteria | |
CYP3A4 | Eligibility Criteria | |
Cytokeratin 18 | Eligibility Criteria | |
cytokine inducible SH2-containing protein | Eligibility Criteria | |
cytotoxic T-lymphocyte-associated protein 4 | Eligibility Criteria, Official Title, Outcome Measure | |
Down syndrome chromosome region | Outcome Measure | |
Epidermal growth factor receptor (EGFR) | Arm Group Description, Arm Group Label, Brief Summary, Brief Title, Detailed Description, Eligibility Criteria, Official Title, Outcome Measure | |
Estrogen receptor alpha (ER alpha) | Eligibility Criteria | |
FANCA | Eligibility Criteria | |
Fibrinogen | Eligibility Criteria | |
Fibroblast Growth Factor (FGF2) | Brief Summary, Outcome Measure | |
Fibroblast growth factor receptor 1 (FGFR1) | Arm Group Label, Brief Summary, Brief Title, Detailed Description, Eligibility Criteria, Official Title | |
Fibroblast growth factor receptor 2 (FGFR2) | Arm Group Label, Brief Summary, Brief Title, Detailed Description, Eligibility Criteria, Official Title | |
Fibroblast growth factor receptor 3 (FGFR3) | Arm Group Label, Brief Summary, Brief Title, Eligibility Criteria, Official Title | |
Fibroblast growth factor receptor 4 (FGFR4) | Arm Group Label, Brief Summary, Brief Title, Eligibility Criteria, Official Title | |
FLT4 | Brief Summary | |
FSH | Eligibility Criteria | |
HAVCR2 (TIM-3) | Outcome Measure | |
HER2/ERBB2 | Brief Summary, Brief Title, Detailed Description, Eligibility Criteria, Official Title | |
Hydrocortisone | Eligibility Criteria | |
IDH1 | Brief Summary, Detailed Description, Eligibility Criteria | |
IDH2 | Brief Summary, Detailed Description | |
Interleukin-6 (IL-6) | Outcome Measure | |
KRAS | Brief Title, Eligibility Criteria, Official Title | |
L-Aspartic acid | Eligibility Criteria | |
LAG-3 (CD223) | Outcome Measure | |
Luteinizing hormone (LH) | Eligibility Criteria | |
Maleic acid | Arm Group Label | |
Mannitol | Eligibility Criteria | |
mannose receptor, C type 1 | Eligibility Criteria | |
membrane associated guanylate kinase, WW and PDZ domain containing 1 | Eligibility Criteria | |
methylmalonic aciduria (cobalamin deficiency) cblB type | Eligibility Criteria | |
MGMT | Arm Group Description, Brief Summary, Brief Title, Detailed Description, Eligibility Criteria, Official Title | |
Microsatellite Instable (MSI) | Brief Title, Eligibility Criteria, Official Title | |
N-acylethanolamine acid amidase | Eligibility Criteria | |
N-Myc | Brief Summary | |
Nuclear protein Ki67 | Eligibility Criteria, Outcome Measure | |
Oxalacetic acid | Eligibility Criteria | |
p63 | Eligibility Criteria | |
PARP-1 | Eligibility Criteria | |
partner and localizer of BRCA2 | Eligibility Criteria | |
PD-1/CD279 | Eligibility Criteria, Official Title, Outcome Measure | |
PD-L1/CD274 | Arm Group Description, Arm Group Label, Brief Summary, Brief Title, Eligibility Criteria, Official Title, Outcome Measure | |
PD-L2 | Eligibility Criteria, Outcome Measure | |
PDGFRA | Brief Summary, Detailed Description, Eligibility Criteria | |
PDGFRB | Brief Summary, Detailed Description, Eligibility Criteria | |
PGR | Eligibility Criteria | |
PLK3 | Brief Summary | |
pregnancy specific beta-1-glycoprotein 2 | Eligibility Criteria | |
Progesterone | Eligibility Criteria | |
Prothrombin (PT) | Eligibility Criteria | |
RAD51 | Eligibility Criteria | |
RAS | Brief Summary, Detailed Description, Eligibility Criteria | |
RET | Arm Group Description, Official Title | |
ring finger protein 2 | Eligibility Criteria | |
ROS1 | Brief Summary, Brief Title, Detailed Description, Eligibility Criteria, Official Title | |
SERPINA2 | Eligibility Criteria | |
T-Cell differentiation antigen CD8 | Outcome Measure | |
T-cell receptor CD3-epsilon (CD3e) | Outcome Measure | |
T-cell receptor T3 delta chain (CD3d) | Outcome Measure | |
T-cell surface antigen CD4 | Eligibility Criteria, Outcome Measure | |
Thyroid stimulating hormone beta (TSH) | Detailed Description, Eligibility Criteria | |
Thyroxine (T4) | Eligibility Criteria | |
Tumor Mutational Burden | Brief Summary, Outcome Measure | |
tumor necrosis factor receptor superfamily, member 4 | Eligibility Criteria | |
VEGFR | Brief Summary, Detailed Description, Eligibility Criteria | |
von Hippel-Lindau tumor suppressor, E3 ubiquitin protein ligase | Eligibility Criteria |
Development Status
Summary Table
Indication | Qualifier | Patient Segment | Phase | Countries | Route / Formulation | Developers | Event Date |
---|---|---|---|---|---|---|---|
Acral lentiginous melanoma | in combination with TQB 2450 | Combination therapy, Late-stage disease, Second-line therapy or greater | Phase I/II | China | PO / Capsule | Chia Tai Tianqing Pharmaceutical Group | 11 Jun 2019 |
Alveolar soft part sarcoma | - | Inoperable/Unresectable, Late-stage disease, Metastatic disease | Phase III | Italy, USA | PO / Capsule | Advenchen Laboratories | 15 Aug 2017 |
Bone cancer | - | In adolescents, In adults, In the elderly, Metastatic disease, Recurrent, Second-line therapy or greater | Phase II | China | PO / Capsule | Chia Tai Tianqing Pharmaceutical Group | 31 Jan 2018 |
Cancer | - | Late-stage disease, Second-line therapy or greater | Phase II | China | PO / Capsule | Chia Tai Tianqing Pharmaceutical Group | 01 Aug 2013 |
Cervical cancer | - | Combination therapy, Metastatic disease, Recurrent | Phase II | China | PO / unspecified | Chia Tai Tianqing Pharmaceutical Group | 31 May 2022 |
Cervical cancer | - | Adjunctive treatment, Metastatic disease, Recurrent, Second-line therapy or greater | Phase I/II | USA | PO / unspecified | Advenchen Laboratories | 01 Dec 2015 |
Cervical cancer | - | Metastatic disease, Recurrent, Second-line therapy or greater | Phase I/II | USA | PO / unspecified | Advenchen Laboratories | 01 Nov 2015 |
Cholangiocarcinoma | in combination with penpulimab | Combination therapy, Inoperable/Unresectable, Metastatic disease, Second-line therapy or greater | Phase II | China | PO / Capsule | Chia Tai Tianqing Pharmaceutical Group | 03 Jun 2020 |
Colorectal cancer | - | Combination therapy, First-line therapy, Inoperable/Unresectable, Metastatic disease | Phase III | China | PO / Capsule | Chia Tai Tianqing Pharmaceutical Group | 27 May 2021 |
Colorectal cancer | - | Late-stage disease, Metastatic disease, Second-line therapy or greater | Phase III | China | PO / Capsule | Chia Tai Tianqing Pharmaceutical Group | 20 Jul 2016 |
Colorectal cancer | in combination with penpulimab | Combination therapy, Inoperable/Unresectable, Metastatic disease, Recurrent | Phase II | China | PO / Capsule | Chia Tai Tianqing Pharmaceutical Group | 03 Jun 2020 |
Endometrial cancer | - | Adjunctive treatment, Metastatic disease, Recurrent, Second-line therapy or greater | Phase I/II | USA | PO / unspecified | Advenchen Laboratories | 01 Dec 2015 |
Endometrial cancer | - | Metastatic disease, Recurrent, Second-line therapy or greater | Phase I/II | USA | PO / unspecified | Advenchen Laboratories | 01 Nov 2015 |
Ewing's sarcoma | - | Late-stage disease, Second-line therapy or greater | Phase II | China | PO / Capsule | Peking University People's Hospital | 22 Jan 2018 |
Fallopian tube cancer | in combination with niraparib | Combination therapy, Recurrent, Second-line therapy or greater | Phase II | China | PO / unspecified | Chia Tai Tianqing Pharmaceutical Group | 12 Mar 2020 |
Fallopian tube cancer | - | Late-stage disease, Second-line therapy or greater | Phase II | China | PO / unspecified | Chia Tai Tianqing Pharmaceutical Group | 01 Mar 2019 |
Fallopian tube cancer | - | Adjunctive treatment, Metastatic disease, Recurrent, Second-line therapy or greater | Phase I/II | USA | PO / unspecified | Advenchen Laboratories | 01 Dec 2015 |
Gastric cancer | - | - | Phase III | China | PO / Capsule | Chia Tai Tianqing Pharmaceutical Group | 20 Jul 2016 |
Gastric cancer | in combination with penpulimab | Combination therapy, Metastatic disease, Recurrent | Phase II | China | PO / Capsule | Chia Tai Tianqing Pharmaceutical Group | 03 Jun 2020 |
Gastrointestinal cancer | with unresectable liver metastases | Adjunctive treatment, Combination therapy, First-line therapy, Inoperable/Unresectable, Metastatic disease | Phase II | China | PO / unspecified | Chia Tai Tianqing Pharmaceutical Group | 01 Dec 2021 |
Gastrointestinal stromal tumours | - | Late-stage disease, Metastatic disease, Recurrent, Second-line therapy or greater | Phase II | China | PO / unspecified | Chia Tai Tianqing Pharmaceutical Group | 23 Oct 2018 |
Glioblastoma | AK105 With Anlotinib and Radiotherapy Adjuvant Therapy | Adjuvant therapy, First-line therapy, Newly diagnosed | Phase II | China | PO / Capsule | Chia Tai Tianqing Pharmaceutical Group | 05 Sep 2021 |
Glioblastoma | - | Late-stage disease | Phase II | China | PO / Capsule | Chia Tai Tianqing Pharmaceutical Group | 13 Apr 2021 |
Head and neck cancer | - | Combination therapy, Late-stage disease, Metastatic disease, Recurrent, Second-line therapy or greater | Phase II | China | PO / Capsule | Chia Tai Tianqing Pharmaceutical Group | 09 May 2020 |
Leiomyosarcoma | - | Inoperable/Unresectable, Late-stage disease, Metastatic disease, Recurrent | Phase III | Italy, USA | PO / Capsule | Advenchen Laboratories | 15 Aug 2017 |
Liver cancer | in combination with penpulimab injection | Adjuvant therapy, Combination therapy, In adults, In the elderly | Phase III | China | PO / Capsule | Chia Tai Tianqing Pharmaceutical Group | 10 May 2023 |
Liver cancer | - | Combination therapy, First-line therapy, Inoperable/Unresectable | Phase II | China | PO / Capsule | Akeso Biopharma, Chia Tai Tianqing Pharmaceutical Group | 22 Nov 2018 |
Nasopharyngeal cancer | - | Combination therapy, First-line therapy, Late-stage disease, Metastatic disease, Recurrent | Phase III | China | PO / Capsule | Chia Tai Tianqing Pharmaceutical Group | 02 Sep 2018 |
Neuroendocrine tumours | Gastroenteropancreatic neuroendocrine tumour | In adults, In the elderly, Inoperable/Unresectable, Late-stage disease, Metastatic disease, Second-line therapy or greater | Phase II | China | PO / Capsule | Chia Tai Tianqing Pharmaceutical Group | 30 Jan 2018 |
Neuroendocrine tumours | in combination with penpulimab | Combination therapy, Late-stage disease | Phase II | China | PO / Capsule | Chia Tai Tianqing Pharmaceutical Group | 03 Jun 2020 |
Non-small cell lung cancer | - | Late-stage disease, Metastatic disease, Second-line therapy or greater | Marketed | China | PO / Capsule | Chia Tai Tianqing Pharmaceutical Group | 11 May 2018 |
Non-small cell lung cancer | in combination with platinum plus pemetrexed | Combination therapy, Late-stage disease, Metastatic disease, Second-line therapy or greater | Phase III | China | PO / Capsule | Chia Tai Tianqing Pharmaceutical Group | 08 Aug 2019 |
Non-small cell lung cancer | in combination with TQB2450, as consolidation treatment | Combination therapy, Inoperable/Unresectable, Late-stage disease, Monotherapy, Second-line therapy or greater | Phase III | China | PO / Capsule | Chia Tai Tianqing Pharmaceutical Group | 30 Mar 2020 |
Non-small cell lung cancer | In combination with Pemetrexed and Carboplatin | Combination therapy, First-line therapy, Late-stage disease, Locally recurrent | No development reported (I) | China | PO / unspecified | Chia Tai Tianqing Pharmaceutical Group | 28 Aug 2023 |
Ovarian cancer | in combination with niraparib | Combination therapy, Recurrent, Second-line therapy or greater | Phase II | China | PO / unspecified | Chia Tai Tianqing Pharmaceutical Group | 12 Mar 2020 |
Ovarian cancer | - | Second-line therapy or greater | Phase II | China | PO / unspecified | Chia Tai Tianqing Pharmaceutical Group | 01 Mar 2019 |
Ovarian cancer | - | Adjunctive treatment, Metastatic disease, Recurrent, Second-line therapy or greater | Phase I/II | USA | PO / unspecified | Advenchen Laboratories | 01 Dec 2015 |
Ovarian cancer | - | Metastatic disease, Recurrent, Second-line therapy or greater | Phase I/II | USA | PO / unspecified | Advenchen Laboratories | 01 Nov 2015 |
Pancreatic cancer | In combination with penpulimab, nab-paclitaxel plus gemcitabine | Combination therapy, First-line therapy, Late-stage disease, Metastatic disease | Phase II | China | PO / Capsule | Chia Tai Tianqing Pharmaceutical Group | 01 Jun 2022 |
Peritoneal cancer | - | Late-stage disease, Second-line therapy or greater | Phase II | China | PO / unspecified | Chia Tai Tianqing Pharmaceutical Group | 01 Mar 2019 |
Peritoneal cancer | in combination with niraparib | Combination therapy, Recurrent, Second-line therapy or greater | Phase II | China | PO / unspecified | Chia Tai Tianqing Pharmaceutical Group | 12 Mar 2020 |
Peritoneal cancer | - | Adjunctive treatment, Metastatic disease, Recurrent, Second-line therapy or greater | Phase I/II | USA | PO / unspecified | Advenchen Laboratories | 01 Dec 2015 |
Renal cell carcinoma | - | Late-stage disease, Second-line therapy or greater | Phase II | China | PO / Capsule | Chia Tai Tianqing Pharmaceutical Group | 01 Dec 2013 |
Small cell lung cancer | in combination with penpulimab | Combination therapy, In adults, In the elderly, Second-line therapy or greater | Phase II | China | PO / unspecified | Chia Tai Tianqing Pharmaceutical Group | 28 Dec 2020 |
Small cell lung cancer | - | Late-stage disease, Second-line therapy or greater | Phase II | China | PO / unspecified | Chia Tai Tianqing Pharmaceutical Group | 01 Mar 2017 |
Small cell lung cancer | - | Combination therapy, First-line therapy, Late-stage disease | Phase II | China | PO / unspecified | Tianquan Pharmaceutical | 15 Jan 2019 |
Soft tissue sarcoma | in combination wth eirubicin hdrochloride | Combination therapy, First-line therapy, Late-stage disease | Phase III | China | PO / Capsule | Chia Tai Tianqing Pharmaceutical Group | 18 Feb 2022 |
Soft tissue sarcoma | - | Late-stage disease, Second-line therapy or greater | Phase II | China | PO / Capsule | Chia Tai Tianqing Pharmaceutical Group | 01 Apr 2013 |
Solid tumours | in combination with TQB 2450 | Combination therapy, Late-stage disease, Metastatic disease | No development reported (I) | China | PO / Capsule | Chia Tai Tianqing Pharmaceutical Group | 28 Aug 2023 |
Squamous cell cancer | oesophageal squamous cell carcinoma | Late-stage disease, Metastatic disease, Second-line therapy or greater | Phase II | China | PO / unspecified | Chia Tai Tianqing Pharmaceutical Group | 01 Jan 2016 |
Squamous cell cancer | In combination with TQB 2450 | Adjunctive treatment, Combination therapy, First-line therapy, In adults, In the elderly, Late-stage disease | Phase II | China | PO / Capsule | Chia Tai Tianqing Pharmaceutical Group | 02 Jun 2023 |
Squamous cell cancer | oesophageal squamous cell carcinoma | Combination therapy, First-line therapy, Late-stage disease | Phase II | China | PO / unspecified | Chia Tai Tianqing Pharmaceutical Group, Henan Cancer Hospital | 07 Oct 2019 |
Squamous cell cancer | - | Combination therapy, First-line therapy, Inoperable/Unresectable, Late-stage disease, Metastatic disease | Phase II | China | PO / Capsule | Chia Tai Tianqing Pharmaceutical Group | 19 Jan 2023 |
Squamous cell cancer | In combination with APL 502 | Adjuvant therapy, Combination therapy | Phase II | China | PO / Capsule | Chia Tai Tianqing Pharmaceutical Group | 02 Jun 2022 |
Synovial sarcoma | - | Inoperable/Unresectable, Late-stage disease, Metastatic disease, Recurrent | Phase III | Italy, USA | PO / Capsule | Advenchen Laboratories | 15 Aug 2017 |
Thyroid cancer | in patients with differentiated thyroid cancer | - | Phase III | China | PO / Capsule | Chia Tai Tianqing Pharmaceutical Group | 20 Jul 2016 |
Thyroid cancer | in patients with medullary thyroid carcinoma | Late-stage disease | Phase III | China | PO / Capsule | Chia Tai Tianqing Pharmaceutical Group | 20 Jul 2016 |
Thyroid cancer | - | Combination therapy, Late-stage disease, Metastatic disease | Phase II | China | PO / Capsule | Chia Tai Tianqing Pharmaceutical Group | 15 Sep 2021 |
Triple negative breast cancer | in combination with taxanes and lobaplatin in the neoadjuvant treatment | Combination therapy, Early-stage disease, Neoadjuvant therapy | Phase II | China | PO / Capsule | Chia Tai Tianqing Pharmaceutical Group | 01 Jan 2021 |
Triple negative breast cancer | - | Combination therapy, Metastatic disease, Second-line therapy or greater | No development reported (I) | China | PO / Capsule | Chia Tai Tianqing Pharmaceutical Group | 28 Aug 2023 |
Urogenital cancer | in combination with penpulimab | Combination therapy, Inoperable/Unresectable, Late-stage disease, Metastatic disease | Phase II | China | PO / Capsule | Chia Tai Tianqing Pharmaceutical Group | 03 Jun 2020 |
Orphan Status
Indication | Patient Segment | Country | Organisation | Event Date |
---|---|---|---|---|
Ovarian cancer | - | USA | Advenchen Laboratories | 01 Jan 2015 |
Soft tissue sarcoma | - | USA | Advenchen Laboratories | 19 Jun 2017 |
Commercial Information
Involved Organisations
Organisation | Involvement | Countries |
---|---|---|
Jiangsu Chia-Tai Tianqing Pharmaceutical | Originator | China |
Advenchen Laboratories | Originator | USA |
Jiangsu Chia-Tai Tianqing Pharmaceutical | Owner | China |
Advenchen Laboratories | Owner | USA |
Nanjing University | Collaborator | China |
Henan Cancer Hospital | Collaborator | China |
Akeso Biopharma | Collaborator | China |
Peking University People's Hospital | Collaborator | China |
Sun Yat-Sen University | Collaborator | China |
Chia Tai Tianqing Pharmaceutical Group | Collaborator | China |
Tianquan Pharmaceutical | Collaborator | China |
Brand Names
Brand Name | Organisations | Indications | Countries |
---|---|---|---|
FOCUS V | Chia Tai Tianqing Pharmaceutical Group | Non-small cell lung cancer | China |
Scientific Summary
Pharmacokinetics
Phase I/II:
In a part I of a phase I/II trial, treatment with catequentinib (12mg) in patients with ovarian (n=1) and endometrial (n=2) cancer, demonstrated the average drug concentration peak time (tmax) as 10 (4.24) hrs and the average max drug blood concentration (cmax) as 9.60 (8.47-11.50) ng/mL. The average tmax reported was 360 hrs (15 days) and the average cmax was 63.80 (52.90-80.30) ng/mL, after multiple, continuous dosing. The trial enrolled 3 patients [113] [112] .
Adverse Events
Acral lentiginous melanoma:
Phase I/II:
Results from a phase I/II trial showed that the combination of TQB 2450 plus anlotinib was tolerable in patients with advanced acral melanoma. The majority of patients (16 of 19 patients) were naive to systemic therapy. No dose limiting toxicity (DLT) was observed. Eighteen (95%) of 19 patients experienced treatment-related adverse events (TRAEs), but most were grade 1 or 2. The most common TRAEs were hypothyroidism, hypertension, blood triglyceride elevation, hyperglycemia, blood cholesterol elevation, neutropenia, blood uric acid elevation, bilirubin elevation. Grade 3 or greater TRAEs occurred in 6 patients (31.6%) [71] [70] .
Phase III
Grade ≥ 3 treatment-related adverse events including hypertension (13.61%, p < 0.0001), dermal toxicity (3.74%, p = 0.019) and hypertriglyceridemia (3.06%, p = 0.034) were observed in patients with advanced non-small cell lung cancer (n = 294), when treated with 12 mg catequentinib, once-daily orally. There were no treatment–related deaths. The randomised, placebo-controlled, double blind phase III ALTER0303 trial enrolled 439 patients [5] [7] .
Phase II/III
Results from the phase II/III trial in patients with medullary thyroid carcinoma showed that catequentinib was well tolerated with a consistent safety profile and no new adverse events. All patients in the catequentinib arm experienced adverse events following treatment compared with 89.66% of patients in placebo arm. Hand-foot syndrome, hypertension, hypertriglyceridaemia and diarrhoea were the most common AEs reported among patients in the catequentinib arm. The trial enrolled 91 patients [63] [64] .
Results from the phase II/III ALTER01032 trial in patients with differenciated thyroid cancer showed that the incidence of treatment-related AEs (TRAEs) in catequentinib and placebo arms was 100% and 86.49%, respectively. About 15.79% in the catequentinib arm experienced serious TRAEs. The most common TRAEs in catequentinib arm included hypertension (84.21%) and hand-foot syndrome (73.68%). The trial enrolled 113 patients [62] [61] .
Data from one of multi-centers in the phase IIb ALTER0203 trial (n = 48) showed that hypertension, elevated TSH, hypertriglyceridaemia as the most common adverse events (AEs). The most common Grade ≥3 AEs were menstrual disorder, hypertension, gamma glutamyl transferase elevation, hand-foot syndrome, hypertriglyceridemia and lipase elevation. The randomised 2:1, double-blind and placebo-controlled phase IIb/III trial is designed to assess the safety and efficacy of catequentinib in 233 patients with soft tissue sarcoma [45] [46] .
Phase I/II:
In a part I of a phase I/II trial, treatment with catequentinib was safe and well tolerated, in patients with ovarian (n=1) and endometrial (n=2) cancer with no dose-limiting toxicities in cycle 1. Grade 1 and 2 treatment emergent adverse events were reported, which includes hypertension (htn), oral pain, epistaxis, pain, insomnia, headache, fatigue, tinnitus, sinus tachycardia, anorexia, fatigue, urinary tract infection and urinary frequency. No significant safety concerns were reported. One patient experienced grade 2 htn and one patient experienced grade 3 htn on C2D2 [113] [112] .
In the phase II, ALTER0802 study, treatment related AEs (TRAEs) were limited to mild hypertention, hand-foot skin reaction and bone and muscular pain. No grade IV or above AEs occurred [105] [106] .
Results from a phase I/II clinical trial of anlotinib in combination with TQB 2450 in patients with EGFR+ advanced non-small scale lung cancer demonstrated favorable safety profile. Among 18 evaluated patients, most frequent TRAE included hypertension (27.8%), hand and foot skin reaction (22.2%) and proteinuria (16.7%). Grade 3 TRAE occurred in 16.7% patients (3/18 pts), all were hypertension, and no Grade 4/5 TRAE were observed. Dose delay due to TRAE occurred in 22.2% patients while no one discontinued treatment due to TRAE. The dose escalation cohort included 9 patients, no dose limiting toxicity occurred [19] [18] .
Results from a phase I/II trial in ovarian cancer at data cutoff date 15 Jan 2021 showed treatment-related grade 3 or 4 adverse events (AEs) in 54.5% patients, and the most common ones were palmar-plantar erythrodysesthesia syndrome (21.2%) and hypertension (18.2%). The most potential immune-related AEs included grade 1 to 2 hypothyroidism (24.2%) and fatigue (9.1%). No treatment-related death was recorded [110] [111]
In a phase Ib/II trial, cadonilimab (AK 104) in combination with catequentinib (anlotinib) demonstrated an acceptable safety profile in treatment-naïve patients with PD-L1 tumour proportion score (TPS) = 1% non-small cell lung cancer (NSCLC). Grade 3 treatment-related adverse events (TRAEs) occurred in 6% (1/18, 1 proteinuria) of patients. No Grade 4 or 5 TRAEs were reported. The results were obtained from 18 treatment-naïve NSCLC patients, squamous/non-squamous with PD-L1 TPS ≥1% ho received combination therapy (2 received 10 mg/kg AK 104, 16 received 15 mg/kg AK 104; and all received 12 mg anlotinib) in part 1 of the trial [16] [17] .
Phase II: Results from the phase II trial showed that catequentinib in patients with relapsed or metastatic primary malignant bone tumor had acceptable toxicity. Most common Gr 3-5 catequentinib-related AEs were hypertension (19.05%), hypertriglyceridemia (9.52%), hand-foot syndrome (7.14%), and proteinuria (4.76%). The open label trial evaluated the safety and efficacy of catequentinib hydrochloride capsule in patients with primary malignant bone tumours with recurrence and distant metastases [96] [97] .
In a phase II trial in oesophageal squamous cell carcinoma patients (n=34) of paclitaxel and cisplatin combined with anlotinib, the common drug-related adverse events were myelosuppression, gastrointestinal reaction, fatigue, hypertension, constipation, hypokalaemia, hepatotoxicity and hemoptysis. And the common grade ≥3 adverse events were myelosuppression (20.6%), hypertension (8.8%), nausea and vomit (5.9%), fatigue (5.9%) and hypokalaemia (5.9%) [60] [59] .
In a phase II trial in patients with ovarian cancer (n=31) of catequentinib, most of the occurring adverse events (AEs) were grade 1 and grade 2, and =10% grade 1 AEs included hypertension (41.94%), fatigue (22.58%), and hand-foot syndrome (29.03%). Grade 2 AEs included gingival bleeding (4.76%), hand-foot syndrome (4.76%), renal dysfunction (4.76%) and cancer pain (4.76%). Grade 3 AEs only included myocardial infarction (4.76%) and urine occult blood (4.76%). No higher-grade AEs were observed. Neither unexpected safety signals nor treatment related death occurred [94] [92] .
Results of the open-label phase II trial of penpulimab, in combination with anlotinib hydrochloride demonstrated manageable safety profile in 25 evaluable patients with unresectable hepatocellular carcinoma. Treatment-related adverse events (TRAEs) occurred in 93.5% of patients (G3 in 9.7% [3/31], no G4, and leading to treatment discontinuation in 6.5% [2/31]). Most frequent TRAEs were increased AST (35.5%), increased ALT (29%), asthenia (22.6%), decreased platelet count (19.4%), increased blood bilirubin (19.4%), increased bilirubin conjugated (19.4%), and rash (16.1%) [90] [89] .
The results of the phase II trial demonstrated that Anlotinib-related adverse events were mostly grade 1 or 2, with 6 (23.1%) of 26 patients experiencing grade 3 adverse events such as neutrophil count decrease (7.7%), white blood cell decrease (7.7%), white blood cell increase (3.8%), and hypertension (3.8%). During the follow-up period, there were no grade 4 or 5 adverse events associated with anlotinib [51] .In phase II trial in patients with recurrent high grade glioma, catequentinib was well tolerated (n=12). Most adverse events were grade 1 or 2. Grade 3 adverse events occurred in 3 out of 12 patients. These included seizures, neutropenia, leukopenia, respectively. A death was reported due to intracranial hemorrhage during the treatment [49] [48] .
Phase I:
Result from a phase I trial demonstrated that twelve participants had treatment-related adverse events (TEAEs) of grade > 3. The most common grade 3 AEs were hypertension (23.7%), neutropenia (19.4%), and bone marrow hypocellular (10.5%). Seven patients discontinued treatment, including two during induction and five during maintenance. No grade 5 TRAE was recorded. In the non-smoker participants, the median PFS was 14.5 (95%CI: 4.0-25.0) months [23] . Result from a phase I trial demonstrated that anlotinib combined with pemetrexed and carboplatin in non-small cell lung cancer was well tolerated, and the AEs were manageable. The most common grade ≥ 3 AEs were hypertension 22.2%, neutropenia 19.44%, myelosuppression 11.1%, thrombocytopenia 8.33%, leukopenia 5.56%, hand-foot syndrome 5.56% and there were no Grade 5 toxicities [24] [22] .
Small cell lung cancer:
In the phase II ALTER1202 trial in patients with advanced small cell lung cancer, treatment with catequentinib was safe and well tolerated. The most common adverse events in catequentinib group were hypertension (37.04%), fatigue (29.63%) and loss of appetite (29.63%) while in placebo group were γ- glutamyl transferase elevation (20.00%) and loss of appetite (20.00 %) [102] [101] .
In a phase II trial, the combination of penpulimab and anlotinib showed a favorable safety profile in small cell lung cancer patients who failed first-line platinum-based chemotherapy. Nineteen of the 21 patients (90%) experienced treatment-related adverse events, with four patients (21%) experiencing grade 3 or higher adverse events. The most common adverse events related to anlotinib were hepatic injury, hematotoxicity, and hypertension [99] [98] .
In a phase I trial in breast cancer patients (n = 34) TQB 2450 plus anlotinib showed an acceptable safety profile. Seventeen patients experienced grade 3 treatment-related AEs (TRAEs). Most frequently occurring (>5%) grade 3 TRAEs were QT interval prolongation (17.65%), hypertension (14.71%), diarrhoea (8.82%), hand-foot syndrome (HFS) (8.82%), and hypertriglyceridaemia (5.88%). In the dose-escalation phase, three patients receiving 10mg anlotinib plus 1200mg TQB 2450 had no dose-limiting toxicities (DLTs) in the first cycle, neither did three patients with 12mg anlotinib plus TQB 2450 [29] [28] .
No new or unexpected safety signals were reported in phase II trial in patients with ovarian cancer. Grade 1 adverse events included hypertention (45.83%), fatigue (29.17%), hand-foot syndrome (33.33%) and hoarseness (12.50%). Grade 2 adverse events included gingival bleeding (4.2%), hand-foot syndrome (4.2%), renal dysfunction (4.2%) and cancer pain (4.2%) [93] . Earlier results from the trial, treatment with catequentinib in combination with peremetex was found to safe and well tolerated. Any grades of adverse events (AEs) were observed in 92.6% (25/27) of patients, containing allergic eruption (33.3%), hand-foot syndrome (29.6%), hypertension (25.9%), and fatigue (25.9%). The grade 3-4 adverse events were only observed in 5 patients, including 1 with grade 3 proteinuria, 1 with grade 3 ascites, 1 with grade 3 fatigue, 1 with grade 3 edema limbs and 1 with grade 4 anemia [91] [92] .
In a phase III trial, treatment with catequentinib was found to be safe. For grade 3 treatment-related adverse events, 12 (23.1%) of patients experienced for catequentinib and 7 (25.9%) of patients experienced for dacarbazine. The most common catequentinib related grade 3 AEs were diarrhea (5.8%) and hypertension (3.8%) [42] [41] .
In the cohort 2 of a phase II study showed that the combination of penpulimab and anlotinib had a favorable safety profile. A total of 14 patients (66.7%) experienced at least one ≥grade 3 treatment-related adverse events (TRAEs) and the most common ≥grade 3 TRAEs was hypertension (15.0%). No treatment-related death was reported [80] . Updated results showed that the common treatment-related adverse events (TEAE) were hypoalbuminemia (75%), hypertension (75%), anemia (75%), and hypertriglyceridemia (62.5%). The incidence of grade 3 or higher treatment-related AEs was 62.5%, and there was one immune-related AE of grade 3 or higher which was hypocalcemia. (TRAEs) were reported in 93.3% patients. The ≥ grade 3 TRAEs occurred in 36.7% patients in which the most common ≥ grade 3 TRAEs included hypothyroidism (6.7%) and hypertension (6.7%). In earlier reported data, Grade 3 treatment-related adverse events (TRAEs) occurred in 30% (6/20, 2 hypertension, 1 hypertriglyceridaemia, 1 gamma-glutamyltransferase increased, 1 palmar-plantar erythrodysaesthesia syndrome and 1 hyponatraemia) of patients. No Grade 4 or 5 TRAEs had observed [78] [79] [77] [76] .
Liver cancer:
Updated results from phase II ALTER-H-004 trial demonstrated that catequentinib indicated a favorable prognosis and tolerable safety profile. Of the 28 patients, 11 were still receiving treatment; however, 9 had relapsed, 3 had withdrawn their consent, and 5 had stopped due to unbearable side effects. Treatment-related adverse events (TRAEs) were experienced by 18 patients (64.3%). Five patients (17.9%) had grade 3 TRAEs found, including ascites (3.6%), leukocytopenia (7.1%), and hypertension (7.1%). There were no TRAEs in grades 4 or 5 [87] . Results from a phase II clinical trial demonstrated that, catequentinib exhibited favorable safety profile in patients (n=25) with liver cancer. Twelve out of 25 patients (48.0%) experienced treatment-related adverse events (TRAEs). Grade 3 TRAEs occurred in 5 patients (20.0%) included hypertension (8.0%), leukocytopenia (8.0%) and ascites (4.0%). No grade 4 or 5 TRAEs occurred, and 3 discontinued because of intolerable adverse events [86] [84] .
Gastric cancer, Neuroendocrine tumours and Urogenital cancer:
Phase II:
In a phase II study of catequentinib and penpulimab injection, the most common TRAEs of any grade observed were hypertension (66.7%), hand-foot syndrome (46.7%), hypothyroidism, hyponatremia and proteinuria (40.0% each). Grade 3 TRAEs occurred in six (40%) patients, the most common of which was hypertension (20%). There was no grade 4-5 TRAEs. Penpulimab was discontinued in obe (6.7%) patient for grade 3 myocarditis [82] [81] .
Adverse events data from phase II ALTER-G-001 trial showed that 37 patients in cohort C had TEAEs and ≥ grade 3 TEAEs (51.2%) mainly included neutropenia (19.5%), white blood cell decreased (12.2%), and blood platelet decreased (9.8%) [34] . Earlier, 36 patients had TEAEs and = grade 3 TEAEs (33.3%) mainly included neutropenia (11.1%), hypertension (6.7%), and white blood cell decreased (6.7%) [35] . 39 patients had treatment emergent adverse events (TEAEs). Incidence of grade 3/4 TEAEs was 25.4%, mainly included neutropenia (11.9%), neutropenia (6.8%) and blood platelet decreased (5.1%) [32] . Previously, 50.9% of patients had treatment emergent adverse events (TEAEs). Incidence of grade 3/4 TEAEs was 16.4%, mainly included white blood cell decreased (7.3%), neutropenia and hypertension (5.5%) [33] [31] .
Treatment with oral atequentinib, combined with taxanes and lobaplatin as a neoadjuvant treatment, was safe and generally well tolerated, in patients (n=45) with triple-negative breast cancer, in the phase II neoALTALL trial. In the safety population (N=45), Grade 3 or 4 TEAEs occurred in 29 patients (64%), and the most common events were neutropenia (38%), leukopenia (27%), thrombocytopenia (25%), anaemia (13%), and hypertension (13%), respectively. No treatment-related deaths occurred. Earlier, all of 24 patients in the safety population showed at least one treatment emergent adverse events (TEAEs). Grade 3 or 4 TEAEs occurred in 14 patients (58.3%), and themost common events were leucopenia (29.2%; n=7), neutropenia (29.2%; n=7), thrombocytopenia (20.8%; n=5), anemia (16.7%; n=4), hypertension (12.5%; n=3), and oral mucositis (8.3%; n=2), respectively [25] [26] [27] .
Squamous cell cancer:
Phase II:
Preliminary results from a phase II trial of APL 502 in combination with catequentinib as first-line therapy in squamous cell cancer demonstrated manageable adverse events. The most common treatment-related adverse events observed in 46 patients with the incidence > 10% were hypertension (28%), hypothyroidism (20%), leukocytosis (20%), hyperthyroidism (17%), anemia (15%), fatigue (15%), neutrophil count decreased (11%), constipation (11%), sinus bradycardia (11%) and hand-foot syndrome (11%). The common grade ≥3 treatment-related adverse events were hypertension (4%), hand-foot syndrome (2%), hyponatremia (2%), platelet count decreased (2%) and lymphocyte count decreased (2%) [57] [56] .
Results from a phase II trial in squamous cell carcinoma demonstrated that the incidence of grade 3-4 treatment emergent adverse events (TEAEs) was 66% (33/50), mainly included neutropenia (34%, 17/50), leukopenia (20%, 10/50) and hypertension (20%, 10/50), platelet count decreased (6%, 3/50). There was no grade 5 TRAE. 17 pts (34%, 17/50) occurred treatment related serious AEs [55] [54] .
Cervical cancer
Phase II: Results from phase II trial in metastatic cervical cancer showed a favourable toxicity profile for patients with persistent, recurrent, or metastatic cervical cancer. Grade ≥3 TRAEs incidence was 42.86% (hypertension: 21.43%, neutropenia: 21.43% leukopenia: 14.29%, and hypertriglyceridemia: 7.14%) [10] [9] .
Pharmacodynamics
Summary
Sub-analysis of the randomised, placebo-controlled, phase IIb/III ALTER01031 trial in patients with medullary thyroid carcinoma observed that catequentinib highly decreased serum calcitonin (Ct). At baseline, 86 of 91 enrolled patients (58 in catequentinib arm and 28 in placebo arm) were recorded their serum Ct levels and no significant difference was observed between two arms (7990.0 ng/L versus 10891.5 ng/L, P = 0.192). After two treatment cycles, the Ct level decreased to 4597.5 ng/L in catequentinib arm (n = 50) while increased slightly in placebo arm (12640.0 ng/L, n = 24, P = 0.006). For 49 patients in catequentinib arm who had complete assessments at baseline and week 6, roughly linear relationship was observed between Ct levels (X-axis) and target lesion diameters (Y-axis) in percent changes from baseline to week 6 (y = 0.175x – 0.049; r = 0.352, P = 0.016, excluding 3 outliers). Patients with less baseline Ct level (≤ median value vs. > median value) did not show more PFS benefit (17.7 versus 22.4 months, P = 0.802). However, after two treatment cycles, a trend of better survival and higher response was observed in patients with high percentage decline of Ct level (> 50%, n = 25) than those with low percentage decline (≤50%, n = 25) although without statistical difference [65] [64] .
Therapeutic Trials
Acral lentiginous melanoma:
Phase I/II
Results from a phase I/II trial of TBQ 2450, in combination with anlotinib, in patients with advanced acral malignant melanoma showed that among all patients with advanced acral melanoma assessed by investigator according to RECIST version 1.1, two patients achieved confirmed complete response and two patients achieved confirmed partial response. The objective response rate (ORR) were 21.1% (95% CI, 6.1% to 45.6%). The disease control rate (DCR) was 73.7% (95% CI, 48.8% to 90.9%). The median progression-free survival (PFS) time was 5.5 months (95% CI, 2.8 months to not reached) per RECIST version 1.1. The median overall survival (OS) was 20.3 months (95% CI, 10.2 months to not reached) [71] [70] .
Phase III:
Treatment with 12 mg catequentinib, once-daily orally, in patients with advanced non-small cell lung cancer (NSCLC), resulted in 66.82% overall survival (OS). An OS of 9.63 months was observed in catequentinib-treated arm (95% CI: 8.17, 10.60, n = 294), compared to 6.30 months with placebo treatment (95% CI: 5.00, 8.10, n = 143) [HR = 0.68 (95% CI: 0.54, 0.87), p = 0.0018]. Progression-free survival of 5.37 months was seen with catequentinib treatment (95% CI: 4.40, 5.63), compared to 1.40 months with placebo (95% CI: 1.07, 1.50) [HR = 0.25 (95% CI: 0.19, 0.31) p < 0.0001]. The catequentinib-treated arm showed an objective response rate (complete response + partial response) of 9.18% and disease control rate (complete response + partial response + stable disease) of 80.95%, compared to 0.7% and 37.06% in the placebo-arm, respectively (p < 0.0001). The randomised, double blind phase III ALTER0303 trial enrolled 439 patients [5] [7] .
In a phase III trial, treatment with catequentinib demonstrated improved disease control and superior progression free survival for catequentinib vs dacarbazine in advanced synovial sarcoma. Overall, PFS was 2.89 months (95% CI: 2.73 – 6.87) for catequentinib and 1.64 (95% CI: 1.45 – 2.70) for D. The PFS of study met the primary endpoint with a p-value of 0.0015 and a HR of 0.449 (95% CI: 0.270– 0.744). At the month 4, 6, and 12, the percentages of progression free patients for catequentinib were 48.1%, 42.3% and 26.9%; and for dacarbazinewere 14.85%, 11.1% and 3.7% [42] [41] .
Small cell lung cancer:
Phase II
Updated results from the phase II ALTER1202 trial in patients with advanced small cell lung cancer, catequentinib significantly improved progress-free survival (PFS) (2.83 vs. 0.69 months; HR =0.10; 95% CI, 0.03–0.28; P0.0001) compared to placebo and prolonged the overall suirval (OS) of 3.75 months without statistical significance (6.51 vs. 2.76 months; HR = 0.52; 95% CI, 0.22–1.23; P =0.1285) compared to placebo. The objective response rate was 3.85% in the catequentinib group and 0% in the placebo group (P =0.442). Stable disease was reported in 16(61.54%) patients in the catequentinib group and no patient in the placebo group. The disease control rate was significantly higher in the catequentinib group (65.38%) than in the placebo group (0, P =0.000043). There was no complete response in either group [102] . Earlier, results from the phase II ALTER 1202 trial showed that catequentinib significantly prolonged both progression free survival (PFS) and overall survival (OS) compared with placebo. In the catequentinib arm, the median OS was significantly prolonged by about 2.4 months compared versus placebo (7.3 months vs 4.9 months). The number of events of OS were reported to be 60 and 33 in the catequentinib arm and placebo arm, respectively (HR 0.53, 95%CI 0.3-0.8; p = 0.0029). In the catequentinib group the rates of six-month and one year survival were 63.9% and 30.6% compared with 32.7% and 13.1% in the placebo group. A favorable hazard ratio for OS was reported for catequentinib in most subgroups, especially for patients with brain metastases (OS: 6.3m vs 2.6m; HR 0.23, 95% CI 0.09-0.59; p = 0.0009) and patients who received study drug as third-line therapy (OS: 7.3m vs 4.9m; HR 0.50, 95%CI 0.31-0.82; p = 0.0051). The trial enrolled 120 patients [100] [101] .
In a phase II trial administration of anlotinib along with penpulimab showed promising clinical benefits in small cell lung cancer patients who failed first-line platinum-based chemotherapy. As of January 31, 2023, 21 patients were enrolled and treated with anlotinib and penpulimab. Of these, 18 patients were evaluable for RECIST and had an objective response rate of 33.33% (6/18) and a disease control rate of 77.78% (14/18). The median progression-free survival (PFS) was 5.934 months with a 6-month PFS rate of 33.33%. The median duration of response was 8 months [99] [98] .
Results from the phase II trial (n=42 efficacy-evaluable patients; 29 patients of osteosarcoma, 9 patients of chondrosarcoma, 3 patients of ewing sarcoma and 1 patient of bone derived malignant fibrous histiocytoma) showed that the progression-free rate at 12 weeks (PFR12weeks), ORR and DCR were 71.3%, 9.52% and 78.57%. Median PFS was 5.26 months (95%CI = 3.48-8.44). Median OS was 11.40 months (95%CI = 10.09, [ ). Median PFS of osteosarcoma and chondrosarcoma was 4.83 months (95%CI = 3.48, 7.13 ) and 2.76 months (95%CI = 1.31, [ ) respectively. The open label trial evaluated the safety and efficacy of catequentinib capsule in patients with primary malignant bone tumours with recurrence and distant metastases [96] [97] .
In a phase II trial in patients with ovarian cancer (n=27) of catequentinib, incidence of complete response, partial response, stable disease and progressive disease was 3.7%, 22.22%, 40.74% and 33.33%, respectively, yielding the ORR of 25.9% (7/27; 95% CI: 11.1-46.3) and the DCR of 66.7% (18/27; 95% CI: 46.0-83.5). The median progression-free-survival (PFS) was 5.32 months (95% CI: 4.31-6.33). The median overall survival (OS) was not reached [94] [92] .
The results of phase II trial showed that four patients received a complete response (CR), seven patients received a partial response (PR), and the objective response rate (ORR) was 42.3% (11/26). The disease control rate (DCR) was 88.5% (23/26), with 12 patients having stable disease (SD). The median progression-free survival (PFS) was 8.3 months [95% CI 3.5-13.1] [51] [48] . In phase II trial in patients with recurrent high grade glioma, catequentinib was well effective and tolerated (n=12). The median PFS was not reached. Out of 12, 11 patients were evaluated and the study showed that 2 achieved complete response (CR), 3 achieved partial response (PR) and the objective response rate (ORR) was 45.4% (5/11). 6 patients had stale disease (SD) and the disease control rate (DCR) was 100% (11/11). The clinical benefit rate (CBR), defined as the proportion of patients who achieved durable disease control (CR/PR/SD) more than 6 months, was 72.7% (8/11) [49] [48] .
Phase II/III
Treatment with catequentinib in non-small lung cancer patients, demonstrated a longer progression free survival (PFS) [HR=0.439, 95% CI (0.211-0.912), P=0.023] in patients with min/baseline<1. The median PFS for the patients with activated circulating endothelial cells (aCECs) min/baseline <1 and ≥1 were 193 days and 124 days, respectively. A decrease of aCECs counts from baseline during an initial period of catequentinib therapy shows longer PFS and good response in NSCLC patients. The trial enrolled 49 patients, including 35 and 14 having aCECs min/baseline<1 and ≥1, respectively [6] [7] .
Results from the phase II/III ALTER01032 trial in patients with differenciated thyroid cancer showed that the trial met its endpoint of progression free survival (PFS). The median PFS in catequentinib arm was 40.54 months (95% CI 28.29, NE) and 8.38 months (95% CI 5.59, 13.80) in placebo arm (p < 0.0001). The HR was 0.21 (95% CI 0.12, 0.37). A trend of overall survival benefit could be observed (Not reached vs. 52.83 months; HR = 0.57 [95% CI 0.29, 1.12]; p = 0.0976). The prolongation in OS became significant (HR = 0.36 [95%CI 0.18, 0.73], P = 0.0033) when a potential bias from crossover (24 pts received open-label anlotinib) was adjusted with a two-stage estimation method. In the catequentinib arm ORR was 59.21% versus no response in placebo arm (p < 0.0001). The duration of complete response (DCR) was 97.37% versus 78.38% in the catequentinib and placebo arm, respectively (p = 0.0019). The trial enrolled 113 patients [62] [61] .
Subanalysis of the phase IIb/III trial of catequentinib in patients (n = 91) with medullary thyroid carcinoma showed that treatment with catequentinib exhibited greater PFS benefits for patients with better functional status (ECOG PS = 0), younger age or lower tumour burden. For patients in placebo arm, PFS was similar regardless of functional status (ECOG PS) or tumour size while older patients had higher progression risk. Treatment with catequentinib exhibited greater PFS benefits for patients with better functional status (ECOG PS = 0), younger age or lower tumour burden. In placebo arm, mPFS did not differ significantly between patients with ECOG PS 0 and 1 (11.3 versus 11.1 months; HR = 0.895 [95% CI 0.347, 2.312], P = 0.821) or between patients with tumour lesion diameter < 67mm and ≥ 67mm (7.0 versus 11.1 months; HR = 1.168 [95% CI 0.463, 2.945], P = 0.737). Patients in catequentinib arm with ECOG PS 0 obtained more PFS benefits (34.6 versus 14.0 months; HR = 0.331 [95% CI 0.163, 0.671], P = 0.002). catequentinib treated patients with tumour lesion diameters < 67mm achieved a longer mPFS (Not reached versus 14.0 months, HR = 0.567 [95% CI 0.280, 1.147], P = 0.111). Consistent with that has been verified in differentiated thyroid cancer, high age predicted poor prognosis as mPFS were 14.3 months and 6.8 months in patients < 55 and ≥ 55 years old respectively in placebo arm (HR = 0.322 [95% CI 0.116, 0.893], P = 0.007).). catequentinib treatment exhibited PFS improvement to patients in both age groups but higher PFS prolongation was observed in patients < 55 years old (22.4 versus 14.0 months; HR = 0.720 [95% CI 0.321, 1.614], P = 0.381) [66] . Interim results showed that the trial met its primary endpoint of progression free survival (PFS) with a longer median PFS of 20.67 months (95% CI: 14.03-34.63) in catequentinib arm compared with 11.07 (95%CI : 5.82-14.32) months in placebo arm (HR - 0.53, p = 0.0289). A 48.39% improvement in objective response rate (ORR) was reported in patients treated with catequentinib versus 3.45% in the placebo patients (p < 0.0001) [63] [64] .
Updated data from the phase IIb ALTER0203 trial in patients of soft tissue sarcoma showed longer median progression free survival (PFS) in patients of age > 40 year (n=79) than ≤40 y (7.43 vs 5.43 months, P=0.40). In patients receiving catequentinib (n=158), median PFS was longer in female (n=76) than male (9.80 vs 4.43 months, P = 0.002). All enrolled patients had a Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. Among 158 patients, 107 patients (67.7%) were with poor PS (ECOG PS = 1). The median PFS was longer in PS of 1 (8.43 vs 4.73, P = 0.53) than PS of 0. Earlier, data from the phase IIb trial (n = 56) showed that, in the first line group, the median PFS was 3 months for placebo versus 15.4 months for catequentinib (p=0.0073). In the second line group, the median PFS was 1.5 months for placebo versus NR for catequentinib (p<0.00010. The ORR was 0% for placebo versus 22.22% for catequentinib (P=0.2652), in the first line group and in the second line, the ORR was 0% for placebo versus 25% for catequentinib (P=0.2808). The DCR was 40% for placebo versus 83.33% for catequentinib (P= 0.0346) in first line, when compared with second, the DCR was 37.5% for placebo and 90% for catequentinib (p=0.0095). The randomised 2:1, double-blind and placebo-controlled phase IIb/III trial is designed to assess the safety and efficacy of catequentinib in 233 patients with soft tissue sarcoma [47] [44] [45] [46] .
In the phase II, ALTER0802 study, in cohort 1, progression-free survival rate at 12 weeks (PFR12w) was 80.8% (95%CI, 67.0-97.4); median overall survival (mOS) was 10.8 months (95%CI, 8.0-NE [not estimated]); median TTP (mTTP) was 5.5 months (95%CI, 4.7-NE); disease control rate was 84.6% (95%CI, 65.1-95.6). In cohort 2, PFR12w was 58.8% (95%CI, 39.5-87.6); mOS was not reached; mTTP was 4.01 mo (95%CI, 1.94-11.4); DCR was 76.5% (95%CI, 50.1-93.2) [105] [106] .
Results from a phase I/II clinical trial of anlotinib in combination with TQB 2450 in patients with EGFR+ advanced non-small scale lung cancer demonstrated promising anti-tumor efficacy. Data from the analyzed patients (n=18) showed, 50% patients harbored EGFR exon19 deletion, 44% patients had exon21 L858R mutation. While 39% patients had T790M mutation who progressed after osimertinib treatment. Thirteen patients in the phase II part were administered with dose of 12 mg for anolitinib and 1200mg for TQB 2450. Of the evaluable patients (n = 18), ORR was 11.1%, DCR was 77.8%, median PFS was 8.0 months (95% CI 4.9 to 11.1) [19] [18] .
Updated results from the phase I trial, in patients with solid tumours showed that an overall response rate (ORR) and a and disease control rate (DCR) of 32.8% and 81.8%, respectively. Partial response were reported in four small cell lung cancer (SCLC) patients and one SCLC patient had stable disease. Earlier data showed that TQB 2450 alone and in combination with 12mg anlotinib in four patients with solid tumours demonstrated unconfirmed partial response (2 SCLC and 2 NSCLC). One SCLC patient with 10mg anlotinib plus TQ B2450 had confirmed partial responses [121] [120] [115] .
Result from a phase I trial demonstrated that anlotinib plus pemetrexed and carboplatin followed by anlotinib plus pemetrexed maintenance therapy could be a promising treatment for patients with wild-type EGFR/ALK advanced nsq-NSCLC. Median PFS was 10.5 (95%CI: 4.1, 17.0) months, and median OS was 23.4 (95%CI: NE, NE) months. The DCR and ORR were 94.7% and 60.5%, respectively [23] . Result from a phase I trial of anlotinib combined with pemetrexed and carboplatin in non-small cell lung cancer demonstrated significantly improved PFS and ORR compared to standard chemotherapy. At data cut-off, 40 patients were enrolled and 31 of them have received at least one tumor assessment. Reported median age was 62; 66.7% male, 11.1% brain metastasis. Patients were followed up for a median of 8.26 months. Reported median PFS was 10.5 months (95% CI: NE, NE); ORR was 67.7% (0 CR, 21 PR), DCR was 96.8% (0 CR, 21 PR, 9 SD) and median OS was NE [24] [22] .
In a phase II trial in oesophageal squamous cell carcinoma patients (n=34) of paclitaxel and cisplatin combined with anlotinib, there were one confirmed CR (2.9%), 26 confirmed PR (76.5%), 2 unconfirmed PR (5.9%) and 5 SD (14.7%). Consequently, ORR was 79.4% (95%CI: 62.1̃91.3) and DCR was 100.0% (95%CI: 89.7̃100.0). Eleven patients discontinued treatment due to PD, the preliminary prognostic result indicated that the median PFS of the 34 patients was 9.76 months (95%CI: 8.44-13.08). And the median OS was not yet available [60] [59] .
In a phase I trial in breast cancer patients treated with TQB 2450 plus anlotinib (n = 34), the objective response rate (ORR) was 26.47% (9/34) and disease control rate (DCR) was 82.35% (28/34). The median progression-free survival (PFS) was 8.57 months. In patients treated with Immune checkpoint inhibitor (ICI), median maximum somatic allele frequency (MSAF) was a robust indicator for both PFS and clinical response. Neutrophil to lymphocyte ratio (NLR) week 2/0 presented a favorable profile indicative of PFS as well as a strong predictor for clinical responsiveness of patients with aTNBC receiving immune checkpoint blockade. Gene alternations primarily comprised mutation, amplification, or deletion of TP53, MLL3, DNMT3A, PI3KCA, EP300, PTEN, LRP1B, MDM2, and NCOR1. The median maximum somatic allele frequency (MSAF) was 9.97% significantly indicative of PFS, which was 3.58 months for the MSAF-high group and 13.34 months for the MSAF-low group (P = 3e-04), respectively. Else, a strong association was also signified between MSAF and tumor shrinkage (CR/PR vs. SD/PD, P = 0.012). For blood tumor mutation burden (bTMB), the median was 6.72 muts/Mb, which the bTMB-low group was suggestive of a better PFS (11.09 months vs. 5.52 months, P = 0.007), yet no obvious association existing in terms of clinical response. Dynamic analysis revealed that a decline in MSAF was significantly associated with a better PFS (7.10 months vs. 2.74 months, P = 0.018), while no correlations were detected between bTMB and PFS. Based on NLR week 2/0 of 0.95, PFS was significantly worse in the NLR-low group (11.0 months vs. 3.5 months, P = 0.006) and likely distinguished the clinical response (CR/PR vs. SD vs. PD, P = 0.049; non-PD vs. PD, P = 0.022). Moreover, NLR week 2/0 could notably foretell the clinical response for patients with aTNBC with the AUC of 0.82 (0.61-1.00). No comparable utilities were identified regarding lymphocyte to monocyte ratio (LMR) and lymphocyte ratio (PLR) [30] [29] [28] .
Catequentinib demonstrated efficacy in phase II trial in patients with ovarian cancer in patients with recurrent platinum-resistant or refractory ovarian carcinoma. Objective response rate (ORR) was achieved in 29.2% of patients with disease control rate of 75% (95% CI: 53.3-90.2). The median progression free survival was 6.34 months (95% CI: 3.14-9.54). Complete response, partial response, stable disease and progression disease was 4.2%, 25%, 45.8% and 25% respectively. The median overall survival was not reached [93] . In the phase II trial, treatment with catequentinib in combination with peremetex demonstrated overall response rate (ORR) 36.4% (partial response (PR) in eight patients; 95% CI: 17.2-59.3) in patients with ovarian cancer. The disease control rate (DCR) was 100.0% (PR in eight patients and stable disease (SD) in 14 patients; 95% CI: 73.5-100). The median time of the first response was 1.6 months (range, 1.3-4.4). The median progression free survival (PFS) was 9.3 months (95% CI: NE-NE). Furthermore, the ORR of patients with and without prior antiangiogenic therapy was 16.7% (95%CI: 2.1-48.4) and 60.0% (95%CI: 26.2-87.8) respectively (P = 0.074) [91] [92] .
Results from the cohort 2 of a phase II trial showed that the combination of penpulimab and anlotinib showed good efficacy in recurrent or metastatic non-squamous cell carcinoma of head and neck. A total of 15 patients (71.4%) had distant metastatic lesions and 12 patients (57.1%) had prior chemotherapy history. Four patients achieved confirmed partial response and the ORR was 19.0%. Stable disease (SD) was observed in 17 patients and the DCR was 100%. The median follow-up for PFS was 14.2 months (95%CI: 7.8, 20.6), nine patients suffered disease progression and the median PFS was 10.6 months (95%CI: 0.0, 22.4) [80] . Previously it was reported that the study met its primary endpoint that 13 patients achieved partial response (PR) and the ORR (confirmed at least 4 weeks after initial response) was 34.21%. 14 patients obtained stable disease (SD) lasting for at least 4 weeks, given a DCR of 76.32%. After a median follow-up of 6.96 months (95%CI: 4.40, 8.80). PFS events were observed in 17 patients and the median PFS was 8.35 months (95%CI: 5.45, 13.11). The PFS at 6 months was 62.5%. 9 patients died and the median OS was not reached (95% CI: 9.43NE). For patients with tumor response, the median DoR was not reached (95% CI: 2.37, NE). At data cut-off 16 April 2022, four patients received only one prior line of chemotherapy. 11 patients were available for tumour assessment, ORR was 18.2%, and DCR was 81.8%. The data on PFS and OS were not mature. The confirmed objective response rate (ORR) was 28% (0 complete response and 7 partial response) and disease control rate (DCR) was 84% (15/20). Stable disease was reported in 14 patients lasting 4 weeks. Progression-free survival (PFS) at 6 months was 64.3%. In the treatment period, progressive disease (PD) was reported in nine patients. For seven patients who reported partial response, only two patients developed the PD and the longest duration of response was 7.2 months [78] [79] [77] [76]
Results of the open-label phase II trial of penpulimab, in combination with anlotinib hydrochloride demonstrated anti-tumour activity in 25 evaluable patients with unresectable hepatocellular carcinoma. Out of 25 evaluable patients (with the opportunity to be followed-up for ≥2 scans, 12 weeks), confirmed ORR was 24% (6/25) and DCR was 84% (21/25). Five responders remained in response with DoR ranging 1.4+ to 6.9+ months. Median TTP was not reached and six months-TTP rate was 63% (95% CI: 38%, 81%) [90] [89] .
Phase I/II
Results from a phase I/II trial in ovarian cancer at data cutoff date 15 Jan 2021 the median follow-up was 5.1 months (range, 0.1–10.8). Thirteen patients from 25 evaluable patients achieved partial response, yielding the ORR of 52.0% (95% CI, 30.4%–71.6%). The median PFS was 6.7 months (95% CI, 4.5 months to not reached). The median duration of response and the median OS were not reached [110] [111]
In a phase Ib/II trial, cadonilimab (AK 104) in combination with catequentinib (anlotinib) demonstrated favourable antitumour activity in treatment-naïve patients with PD-L1 tumour proportion score (TPS) = 1% non-small cell lung cancer (NSCLC). In 8 evaluable patients, the objective response rate (ORR) was 62.5% (5/8) and disease control rate (DCR) was 100% (8/8). Among them, the ORR was 80% (4/5) in non-squamous NSCLC. The results were obtained from 18 treatment-naïve NSCLC patients, squamous/non-squamous with PD-L1 TPS ≥1% ho received combination therapy (2 received 10 mg/kg AK 104, 16 received 15 mg/kg AK 104; and all received 12 mg anlotinib) in part 1 of the trial [16] [17] .
Gastric cancer, Neuroendocrine tumours and Urogenital cancer:
Phase II:
In a phase II study of catequentinib and penpulimab injection in patients with gastrointestinal tumours, urinary system tumours, neuroendocrine tumours, the confirmed objective response rate (ORR) observed was 33.3%. The disease control rate (DCR) was 80.0%, with partial response and stable disease recorded in five (33.3%) and seven(46.7%) patients. The median progression-free survival (PFS) was 6.8 months (95%CI 1.3-12.2). The median duration of response (DOR) was not reached, and the overall survival (OS) is currently immature [82] [81] .
Liver cancer
Updated results from phase II ALTER-H-004 trial demonstrated that the 1-year DFS rate was 76.46% (95% CI: 54.83-88.70), and the 2-year DFS rate was 65.41% (95% CI: 41.70-81.39), however, the median DFS has not yet been attained [87] . Results from a phase II clinical trial demonstrated that, catequentinib exhibited promising clinical benefit in patients with liver cancer. According to RECIST 1.1, 14 of 25 did not progressed and 7 patients were relapsed, as of data cut-off (the longest duration of treatment was 16.53 months). The DFS were not mature and the 6-month DFS rates were 77.45% (95% CI: 53.83̃89.99) [86] [84] .
Treatment with oral atequentinib, combined with taxanes and lobaplatin as a neoadjuvant treatment, showed efficacy, in patients (n=45) with triple-negative breast cancer, in the phase II neoALTALL trial. In the ITT population, 26 out of 45 patients achieved tpCR (57.8%; 95% CI, 42.2%–72.3%), and 39 achieved RCB 0-I (86.7%; 95% CI, 73.2%-94.9%). The bpCR and apCR rates were 64.4% (29/45) and 71.9% (23/32), respectively. No recurrence or metastasis occurred during the short-term follow-up. Based on the FUSCC IHC-based subtypes, the tpCR rates were 68.8% (11/16) for IM subtype, 58.3% (7/12) for BLIS subtype, and 33.3% (4/12) for LAR subtype, respectively. Next-generation sequencing revealed that the tpCR were 69.2% (9/13) and 53.6% (15/28) in MYC-amplified and wild-type patients, respectively, and 75.0% (9/12) and 51.7% (15/29) in BRCA1/2-mutated and wild-type patients, respectively. Earlier, after surgery, 14 out of 24 patients achieved a pathological complete response (pCR) in the breast and axilla (tpCR) (58.3%;95% CI, 36.6%77.9%), and the pCR in the breast (bpCR) rate was also 58.3% (14/24). Of the 18 patients with the node-positive disease at diagnosis, 15/18 (83.3%) became ypN0. Based on the FUSCC IHC-based subtypes, the tpCR rates were 66.7% (6/9) for BLIS subtype, 80% (4/5) for IM sub type and 0% (0/4) for LAR subtype, respectively. Next-generation sequencing revealed that the most commonly mutated genes in these patients were TP53 (19/21, 90.5%), MYC (7/21, 33.3%), BRCA1(5/21, 23.8%), PIK3CA (4/21, 19.0%), BCL2L11 (4/21, 19.0%), and RB1 (3/21, 14.3%). Subgroup analysis showed that the tpCR were 71.4% (5/7) and 42.9% (6/14) in MYC-amplified and wild-type patients, respectively, and 80% (4/5) and 43.8% (7/16) in BRCA1-mutated and wild-type patients, respectively. The addition of anlotinib to neoadjuvant chemotherapy showed manageable toxicity and promising anti-tumour activity for patients with early-stage TNBC [25] [26] [27] .
Efficacy data from phase II ALTER-G-001 trial showed that of 37 evaluable patients in cohort C, ORR and DCR were 45.9% and 86.5% (PR, n=17; SD, n=15, 12 SD had reduced tumor size). Of 25 evaluable pancreatic cancer patients, 12 had PR, 10 had SD, ORR and DCR were 48% and 88%. According to the Kaplan-Meier method, the median DoR was 4.2 months (95%CI, 1.7-6.6) and the median PFS was 5.5 months (95%CI, 4.7-6.3) [34] . Earlier, Of 39 evaluable patients in cohort A, ORR and DCR were 48.7% and 97.4% (PR, n=19; SD, n=19, 16 SD had reduced tumor size). The median PFS was not reached. In 13 evaluable patients with pancreatic cancer, seven had partial response, five had SD, with an objective response rate of 53.8%. [35] After induction therapy, eight patients (five colorectal cancer , one pancreatic cancer, one gastric cancer, one biliary tract cancer) received surgical resection. In 16 evaluable patients in cohort A, 11 reached partial response (PR) and five had stable disease (SD). The ORR of cohort A was 68.8% and DCR was 100.0%. For two esophageal squamous cell carcinoma patients in cohort B, the best response were both PR. 24 patients of cohort C were response evaluable, among whom 11 had PR, 10 had SD, with an ORR of 45.8% and DCR of 87.5% [32] . In 24 evaluable patients in cohort C, 12 had partial response (PR), 9 had stable disease (SD). ORR was 50.0% and DCR was 87.5%. Among 13 evaluable pts with PC, 7 had PR, 5 had SD, with an ORR of 53.8%. In 15 evaluable pts in cohort A, 11 reached PR and 4 had SD. The ORR of cohort A was 73.3% and DCR was 100.0%. For one evaluable ESCC patients in cohort B, the best response was PR. The median PFS was not reached [33] [31] .
Squamous cell cancer:
Phase II:
Preliminary results from a phase II trial of APL 502 in combination with catequentinib as first-line therapy in squamous cell cancer demonstrated encouraging efficacy. From Mar 2022 to Sep 2022, a total of 46 patients were enrolled. At the data cut-off date (Dec, 2022), there were 1 CR (2.2%), 27 PR (58.7%), 14 SD (30.4%) and 4 NE (8.7%). Therefore, the preliminary ORR was observed to be 60.9% (95%CI), DCR was 91.3% (95%CI) [57] [56] .
Results from a phase II trial in squamous cell carcinoma demonstrated that at the data cutoff date of January 16, 2023, 45 patients were tumor response evaluable, among whom, 3 patients achieved complete response, 34 had partial response and 8 had stable disease. The ORR was 82.2% (95% CI: 68.0%, 92.0%) and the DCR was 100.0% (95% CI: 92.1%, 100.0%). Median PFS was not reached [55] [54] .
Cervical cancer
Phase II: Results from phase II trial in metastatic cervical cancer indicated that 2 cycles of chemotherapy + penpulimab + anlotinib in first-line treatment, maintaining with penpulimab and anlotinib showed promising efficacy. (7.1%) patient achieved CR, 11 (78.6 %) patients achieved PR, 1 (7.1%) SD and 1 (7.1%) patient NE. The ORR was 85.7%. Median PFS and OS were not reached [10] [9] .
Future Events
Expected Date | Event Type | Description | Updated |
---|---|---|---|
31 Oct 2022 | Trial Update | Chia Tai Tianqing Pharmaceutical Group plans a phase I pharmacokinetic trial (In adults, In the elderly) in China (PO,Capsule) (NCT05559242) (700357334) | 04 Oct 2022 |
30 Apr 2022 | Trial Update | Liaoning Tumor Hospital & Institute plans a phase II ALTER-BC-003 trial in advanced Breast cancer in females (Combination therapy, Late-stage disease, First line therapy, Metastatic) in April 2022 (NCT05244993) (700348823) | 21 Feb 2022 |
01 Mar 2022 | Trial Update | The First Affiliated Hospital of Zhengzhou University plans a phase II trial in Cervical cancer (Combination therapy, Late-stage disease, Metastatic disease, Recurrent, Second-line therapy or greater) (PO) in March 2022 (NCT05137171) (700345294) | 02 Dec 2021 |
28 Feb 2022 | Trial Update | Chia Tai Tianqing Pharmaceutical Group and Jiangxi Provincial Cancer Hospital plans the phase II ALTER-E005 in Squamous cell carcinoma (Adjuvant therapy, Combination therapy) (PO, Capsule) (NCT05252078) (700349019) | 28 Dec 2022 |
21 Jan 2022 | Trial Update | Sun Yat-sen University plans a phase II trial for Nasopharyngeal cancer (Combination therapy, Metastatic disease) in January 2022 (NCT05193617) | 06 Feb 2022 |
31 Dec 2021 | Trial Update | Chia Tai Tianqing Pharmaceutical Group plans a phase III trial for Ovarian Cancer (Combination therapy, Second line or greater therapy) in China (PO, Capsule) in December 2021 (NCT05145218) (700345597) | 08 Dec 2021 |
18 Nov 2021 | Trial Update | Chia Tai Tianqing Pharmaceutical Group plans a phase III trial for Soft tissue sarcoma (Combination therapy, Late-stage disease, First-line therapy) in China (NCT05121350) | 01 Mar 2022 |
01 Nov 2021 | Trial Update | The First Affiliated Hospital of Zhengzhou University plans a phase II trial for Squamous cell carcinoma (Late-stage disease, Metastatic disease, Combination therapy, Inoperable/Unresectable) (PO) in November 2021 (NCT05038813) | 15 Sep 2021 |
31 Aug 2021 | Trial Update | Tianjin Medical University Cancer Institute and Hospital and Chia Tai Tianqing Pharmaceutical plan a phase II in Non-small cell lung cancer (Combination therapy, Late-stage disease, Metastatic disease) in China (PO) in August 2021 (NCT04846634) (700335928) | 15 Sep 2021 |
01 Jun 2021 | Trial Update | Chia Tai Tianqing Pharmaceutical Group plans a phase III trial for Colorectal cancer (Combination therapy, Metastatic disease, Inoperable/unresectable, First-line therapy) in China (PO) in June 2021 (NCT04854668) (700336223) | 30 Aug 2021 |
30 Apr 2020 | Trial Update | Chia Tai Tianqing Pharmaceutical Group plans a phase III trial for Non-small-cell lung cancer (Combination therapy, Late-stage disease, Inoperable/Unresectable, Second-line therapy or greater) in China in April 2020 (NCT04325763) (700320320) | 17 Jul 2020 |
31 Mar 2020 | Trial Update | Chia Tai Tianqing Pharmaceutical Group plans a phase II trial for Solid tumours (Late-stage disease, Combination therapy) in China (PO) in March 2020 (NCT04291248) (700319405) | 15 Sep 2021 |
31 Jan 2020 | Trial Update | Chia Tai Tianqing Pharmaceutical Group plans a phase I/II trial for TQB 2450 in combination with anlotinib for Epithelial ovarian, Fallopian tube or Primary peritoneal cancer (Combination therapy, In adults, In the elderly, Second-line therapy or greater) (IV) in China in January 2020 (NCT04236362) | 09 Jul 2020 |
01 Jan 2020 | Trial Update | Chia Tai Tianqing Pharmaceutical Group plans a phase II trial for Head, neck and chest cancer (Late-stage disease, Metastatic disease, Combination therapy) in China in January 2020 (NCT04203719) (700316191) | 09 Jul 2020 |
01 Jan 2020 | Trial Update | Chia Tai Tianqing Pharmaceutical Group plans a phase II trial for Cholangiocarcinoma (Metastatic disease, Combination therapy, Inoperable/Unresectable, Second-line therapy or greater), Colorectal cancer (Recurrent, Metastatic disease, Combination therapy, Inoperable/Unresectable), Gastric cancer (Recurrent, Metastatic disease, Combination therapy), Urogenital cancer (Metastatic disease, Late-stage disease, Combination therapy, Inoperable/Unresectable), Neuroendocrine tumours (Late-stage disease, Combination therapy) in China in January 2020 (NCT04207463) (700316388) | 26 Jun 2020 |
31 Oct 2019 | Trial Update | Chia Tai Tianqing Pharmaceutical plans a phase III trial (Combination therapy) for Non-small Cell Lung Cancer in China (NCT04073537) (700310950) | 15 Sep 2021 |
31 Oct 2019 | Trial Update | Chia Tai Tianqing Pharmaceutical plans a phase III trial (Combination therapy) for Small cell lung cancer in China (NCT04073550) (700310954) | 15 Sep 2021 |
25 Jun 2019 | Trial Update | Chia Tai Tianqing Pharmaceutical Group plans a phase I/II trial for Melanoma (Late-stage disease, Combination therapy, In adults, In the elderly, Second-line therapy or greater) in China (NCT03991975) (700308620) | 15 Nov 2019 |
10 May 2019 | Trial Update | Chia Tai Tianqing Pharmaceutical Group plans a phase I trial in Solid tumours (Combination therapy, Late stage disease, Metastatic disease) in May 2019 (PO) (NCT03897283) (700306031) | 30 Nov 2020 |
17 Aug 2018 | Trial Update | Jiangsu Chia-tai Tianqing Pharmaceutical plans a phase III trial for Nasopharyngeal cancer (Recurrent; Late-stage disease, Combination therapy, First-line therapy, Metastatic disease) in August 2018 (PO) (700298206) (NCT03601975) | 26 Sep 2018 |
Development History
Event Date | Update Type | Comment |
---|---|---|
18 Jan 2024 | Scientific Update | Efficacy and adverse events data from the phase II ALTER-G-001 trial in Gastrointestinal cancer presented at Gastrointestinal Cancers Symposium (ASCO-GCS-2024) [35] [34] Updated 07 Mar 2024 |
20 Oct 2023 | Scientific Update | Efficacy and safety data from the phase II trial in cervical cancer presented at the 48th European Society for Medical Oncology Congress (ESMO-2023) [10] Updated 13 Dec 2023 |
20 Oct 2023 | Scientific Update | Updated efficacy and safety data from the phase II neoALTALL trial in Triple-negative-breast-cancer presented at the 48th European Society for Medical Oncology Congress (ESMO-2023) [25] Updated 07 Dec 2023 |
28 Aug 2023 | Phase Change - No development reported | No recent reports of development identified for phase-I development in Non-small-cell-lung-cancer(Combination therapy, First-line therapy, Late-stage disease, Locally recurrent) in China (PO) Updated 28 Aug 2023 |
28 Aug 2023 | Phase Change - No development reported | No recent reports of development identified for phase-I development in Solid-tumours(Combination therapy, Late-stage disease, Metastatic disease) in China (PO, Capsule) Updated 28 Aug 2023 |
28 Aug 2023 | Phase Change - No development reported | No recent reports of development identified for phase-I development in Triple-negative-breast-cancer(Combination therapy, Metastatic disease, Second-line therapy or greater) in China (PO, Capsule) Updated 28 Aug 2023 |
01 Aug 2023 | Phase Change - I | Phase-I clinical trials in Liver cancer (First-line therapy, Combination therapy, Late-stage disease) in China (IV) (NCT05975645) Updated 10 Aug 2023 |
28 Jun 2023 | Scientific Update | Efficacy and adverse events data from a phase II ALTER-G-001 trial in Gastrointestinal cancer presented at the 25th World Congress on Gastrointestinal Cancer (WCGC-2023) [32] Updated 21 Aug 2023 |
02 Jun 2023 | Scientific Update | Efficacy and adverse events data from a phase II trial in Head and neck cancer presented at the 59th Annual Meeting of the American Society of Clinical Oncology (ASCO-2023) [80] Updated 09 Jul 2023 |
02 Jun 2023 | Phase Change - II | Phase-II clinical trials in Squamous cell cancer (Adjunctive treatment, First-line therapy, Late-stage disease, In adults, In the elderly, Combination therapy) in China (PO) (before June 2023) (NCT05013697) Updated 08 Jul 2023 |
02 Jun 2023 | Scientific Update | Efficacy and adverse events data from a phase II trial in Small cell lung cancer presented at the 59th Annual Meeting of the American Society of Clinical Oncology (ASCO-2023) [99] Updated 08 Jul 2023 |
02 Jun 2023 | Scientific Update | Efficacy and adverse events data from a phase II trial in Squamous cell cancer presented at the 59th Annual Meeting of the American Society of Clinical Oncology (ASCO-2023) [55] Updated 08 Jul 2023 |
02 Jun 2023 | Scientific Update | Updated efficacy and adverse event data from a phase II ALTER-H-004 trial in gastrointestinal tumours presented at the 59th Annual Meeting of the American Society of Clinical Oncology (ASCO-2023) [33] Updated 07 Jul 2023 |
02 Jun 2023 | Scientific Update | Updated efficacy and adverse event data from a phase II ALTER-H-004 trial in Liver cancer presented at the 59th Annual Meeting of the American Society of Clinical Oncology (ASCO-2023) [87] Updated 06 Jul 2023 |
02 Jun 2023 | Scientific Update | Safety and efficacy data from a phase II trial in Squamous cell cancer presented at the 59th Annual Meeting of the American Society of Clinical Oncology (ASCO-2023) [57] Updated 28 Jun 2023 |
24 May 2023 | Trial Update | Chia Tai Tianqing Pharmaceuticals completes a I trial in Non small cell lung cancer (Second-line therapy or greater, Combination therapy, Late-stage disease, Metastatic disease) in China (NCT03910127) Updated 29 May 2023 |
10 May 2023 | Phase Change - III | Phase-III clinical trials in Liver cancer (Combination therapy, Adjuvant therapy, In adults, In the elderly) in China (PO) (NCT05862337) Updated 23 May 2023 |
19 Jan 2023 | Phase Change - II | Phase-II clinical trials in Squamous cell cancer (First-line therapy, Late-stage disease, Inoperable/Unresectable, Metastatic disease, Combination therapy) in China as of January 2023 (PO) (NCT05038813) Updated 27 Feb 2023 |
06 Dec 2022 | Scientific Update | Efficacy and safety data from a phase II neoALTALL trial in Triple-negative-breast-cancer presented at the 45th Annual San Antonio Breast Cancer Symposium [26] Updated 13 Feb 2023 |
06 Dec 2022 | Trial Update | Chia Tai Tianqing Pharmaceutical completes enrolment in the phase II trial in Triple-negative-breast-cancer (Neoadjuvant therapy, Early-stage disease, Combination therapy) in China (PO), prior to December 2022 (ChiCTR2100043027) Updated 13 Feb 2023 |
14 Nov 2022 | Trial Update | Advenchen Laboratories initiates an expanded-access programme for Sarcoma in the US (NCT05612191) Updated 14 Nov 2022 |
29 Sep 2022 | Trial Update | Chia Tai Tianqing Pharmaceutical Group plans a phase I pharmacokinetic trial (In adults, In the elderly) in China (PO,Capsule) (NCT05559242) Updated 04 Oct 2022 |
10 Sep 2022 | Scientific Update | Updated adverse events and efficacy data from a phase-II trial in Head, neck and chest cancer presented at the 47th European Society for Medical Oncology Congress (ESMO-2022), [78] Updated 06 Nov 2022 |
09 Sep 2022 | Scientific Update | Efficacy data from a phase II trial in Gastric cancer, Neuroendocrine tumours and Urogenital cancer presented at the 47th Annual Congress of the European Society for Medical Oncology (ESMO-2022) [82] Updated 06 Nov 2022 |
09 Sep 2022 | Scientific Update | Efficacy and adverse event data from Phase II trial in Glioblastoma presented at the 47th European Society for Medical Oncology Congress (ESMO-2022) Updated 05 Nov 2022 |
03 Jun 2022 | Scientific Update | Efficacy and adverse events data from a phase II trial in Liver cancer presented at the 58th Annual Meeting of the American Society of Clinical Oncology (ASCO-2022) [86] Updated 15 Jul 2022 |
03 Jun 2022 | Scientific Update | Efficacy and adverse events data from phase I trial in Non-small cell lung cancer presented at the 58th Annual Meeting of the American Society of Clinical Oncology (ASCO-2022) [23] Updated 13 Jul 2022 |
03 Jun 2022 | Scientific Update | Efficacy and adverse events data from a phase I/II trial in Acral lentiginous melanoma presented at the 58th Annual Meeting of the American Society of Clinical Oncology (ASCO-2022) [71] Updated 05 Jul 2022 |
03 Jun 2022 | Scientific Update | Efficacy data from a phase I/II trial in Ovarian cancer presented at 58th Annual Meeting of the American Society of Clinical Oncology (ASCO-2022) [30] Updated 29 Jun 2022 |
02 Jun 2022 | Phase Change - II | Phase-II clinical trials in Squamous cell cancer (Adjuvant therapy, Combination therapy) in China (PO) (NCT05252078) Updated 28 Dec 2022 |
01 Jun 2022 | Phase Change - II | Phase-II clinical trials in Pancreatic cancer (Combination therapy, First-line therapy, Late-stage disease, Metastatic disease) in China (PO) (NCT05493995) Updated 16 Aug 2022 |
31 May 2022 | Phase Change - II | Phase-II clinical trials in Cervical cancer (Recurrent, Metastatic disease, Combination therapy) in China (PO) Updated 13 Dec 2023 |
23 Feb 2022 | Trial Update | Chia Tai Tianqing Pharmaceutical Group and Jiangxi Provincial Cancer Hospital plans the phase II ALTER-E005 in Squamous cell carcinoma (Adjuvant therapy, Combination therapy) (PO, Capsule) (NCT05252078) Updated 28 Dec 2022 |
21 Feb 2022 | Trial Update | Liaoning Tumor Hospital & Institute plans a phase II ALTER-BC-003 trial in advanced Breast cancer in females (Combination therapy, Late-stage disease, First line therapy, Metastatic) in April 2022 (NCT05244993) Updated 21 Feb 2022 |
18 Feb 2022 | Phase Change - III | Phase-III clinical trials in Soft tissue sarcoma (Combination therapy, Late-stage disease, First-line therapy) in China (PO) (NCT05121350) Updated 01 Mar 2022 |
21 Jan 2022 | Trial Update | Sun Yat-sen University plans a phase II trial for Nasopharyngeal cancer (Combination therapy, Metastatic disease) in January 2022 (NCT05193617) Updated 06 Feb 2022 |
14 Jan 2022 | Biomarker Update | Biomarkers information updated Updated 16 Jan 2022 |
08 Dec 2021 | Trial Update | Chia Tai Tianqing Pharmaceutical Group plans a phase III trial for Ovarian Cancer (Combination therapy, Second line or greater therapy) in China (PO, Capsule) in December 2021 (NCT05145218) Updated 08 Dec 2021 |
01 Dec 2021 | Phase Change - II | Phase-II clinical trials in Gastrointestinal cancer (Adjunctive treatment, Combination therapy, First-line therapy, Metastatic disease, Adjunctive treatment) in China (PO) (NCT05262335) Updated 15 Mar 2022 |
30 Nov 2021 | Trial Update | The First Affiliated Hospital of Zhengzhou University plans a phase II trial in Cervical cancer (Combination therapy, Late-stage disease, Metastatic disease, Recurrent, Second-line therapy or greater) (PO) in March 2022 (NCT05137171) Updated 02 Dec 2021 |
18 Nov 2021 | Trial Update | Chia Tai Tianqing Pharmaceutical Group plans a phase III trial for Soft tissue sarcoma (Combination therapy, Late-stage disease, First-line therapy) in China (NCT05121350) Updated 01 Mar 2022 |
11 Nov 2021 | Trial Update | Chia Tai Tianqing Pharmaceutical completes the ALTER-L029 phase II trial in Non small cell lung cancer (Late-stage disease, Metastatic disease, Inoperable/unresectable) in China (NCT03743129) Updated 22 Jun 2023 |
06 Oct 2021 | Trial Update | Chia Tai Tianqing Pharmaceutical initiates enrolment in a phase II trial for Colorectal cancer (Combination therapy, First-line therapy, Unresectable, Metastatic disease, Late-stage diseases) in China (NCT05068206) Updated 06 Oct 2021 |
16 Sep 2021 | Scientific Update | Efficacy and safety data from a phase Ib/II trial in Non-small cell lung cancer presented at the 46th European Society for Medical Oncology Congress (ESMO-2021) [16] Updated 25 Nov 2021 |
16 Sep 2021 | Scientific Update | Updated efficacy and adverse event data from a phase II trial in Head and neck cancer presented at the 46th European Society for Medical Oncology Congress (ESMO-2021) [79] Updated 25 Nov 2021 |
16 Sep 2021 | Scientific Update | Efficacy and adverse events data from a phase II trial in Glioblastoma presented at the 46th European Society for Medical Oncology Congress [49] Updated 24 Nov 2021 |
16 Sep 2021 | Scientific Update | Efficacy and adverse events data from a phase II trial in Ovarian cancer presented at the 46th European Society for Medical Oncology Congress (ESMO-2021) [94] Updated 18 Nov 2021 |
15 Sep 2021 | Phase Change - II | Phase-II clinical trials in Thyroid cancer (Late-stage disease, Metastatic disease, Combination therapy) in China (PO) (NCT04952493) Updated 08 Feb 2022 |
14 Sep 2021 | Trial Update | Chia Tai Tianqing Pharmaceutical and Hunan Cancer Hospital complete phase II trial for Non-small cell lung cancer (Combination therapy, Late-stage disease, Second-line therapy or greater) in China (PO) before September 2021 (NCT03624309) Updated 12 Oct 2021 |
09 Sep 2021 | Trial Update | The First Affiliated Hospital of Zhengzhou University plans a phase II trial for Squamous cell carcinoma (Late-stage disease, Metastatic disease, Combination therapy, Inoperable/Unresectable) (PO) in November 2021 (NCT05038813) Updated 15 Sep 2021 |
05 Sep 2021 | Phase Change - II | Phase-II clinical trials in Glioblastoma (Adjuvant therapy, Newly diagnosed, First-line therapy) in China (PO) (NCT05033587) Updated 09 Sep 2021 |
30 Aug 2021 | Active Status Review | CTP 336223: updated, KDM, dev T for trial initiation, completed relevant FE Updated 30 Aug 2021 |
04 Jun 2021 | Trial Update | Tianquan Pharmaceutical completes a phase-II study in Small cell lung cancer (First-line therapy, Combination therapy, Late-stage disease) in China (PO) (ChiCTR2000035043) [103] Updated 05 Aug 2021 |
04 Jun 2021 | Scientific Update | Efficacy and adverse event data from a phase II trial in Head and neck cancer presented at the 57th Annual Meeting of the American Society of Clinical Oncology (ASCO-2021) [77] Updated 31 Jul 2021 |
04 Jun 2021 | Scientific Update | Efficacy and adverse events data from a phase III trial in Synovial sarcoma presented at the 57th Annual Meeting of the American Society of Clinical Oncology (ASCO-2021) [42] Updated 28 Jul 2021 |
04 Jun 2021 | Trial Update | Advenchen Laboratories completes enrolment in its phase III trial in Synovial sarcoma (Late-stage disease, Metastatic disease, Recurrent, Inoperable/Unresectable) in Italy and USA (PO) (NCT03016819) [42] Updated 28 Jul 2021 |
04 Jun 2021 | Scientific Update | Efficacy and adverse events data from a phase II trial in Oesophageal squamous cell carcinoma presented at 57th Annual Meeting of the American Society of Clinical Oncology (ASCO-2021) [60] Updated 26 Jul 2021 |
04 Jun 2021 | Scientific Update | Efficacy and safety data from a phase I/II trial in Ovarian cancer presented at 57th Annual Meeting of the American Society of Clinical Oncology (ASCO-2021) [111] Updated 26 Jul 2021 |
04 Jun 2021 | Scientific Update | Efficacy and safety data from a phase I/II trial in Ovarian cancer presented at 57th Annual Meeting of the American Society of Clinical Oncology (ASCO-2021) [111] Updated 24 Jul 2021 |
04 Jun 2021 | Scientific Update | Efficacy and adverse events data from a phase II trial in Ovarian cancer presented at the 57th Annual Meeting of the American Society of Clinical Oncology (ASCO-2021) [91] Updated 23 Jul 2021 |
04 Jun 2021 | Scientific Update | Efficacy and safety data from a phase I trial in Triple-negative-breast cancer presented at 57th Annual Meeting of the American Society of Clinical Oncology (ASCO-2021) [29] Updated 22 Jul 2021 |
04 Jun 2021 | Scientific Update | Initial efficacy and adverse events data from a phase II trial in Non-small cell lung cancer presented at the 57th Annual Meeting of the American Society of Clinical Oncology (ASCO-2021) [19] Updated 10 Jul 2021 |
04 Jun 2021 | Scientific Update | Initial efficacy and adverse events data from a phase I trial in Non-small cell lung cancer presented at the 57th Annual Meeting of the American Society of Clinical Oncology (ASCO-2021) [24] Updated 09 Jul 2021 |
27 May 2021 | Phase Change - III | Phase-III clinical trials in Colorectal cancer (First-line therapy, Combination therapy, Inoperable/Unresectable, Metastatic disease) in China (PO) (NCT04854668) Updated 30 Aug 2021 |
22 Apr 2021 | Trial Update | Chia Tai Tianqing Pharmaceutical Group plans a phase III trial for Colorectal cancer (Combination therapy, Metastatic disease, Inoperable/unresectable, First-line therapy) in China (PO) in June 2021 (NCT04854668) Updated 30 Aug 2021 |
19 Apr 2021 | Trial Update | Tianjin Medical University Cancer Institute and Hospital and Chia Tai Tianqing Pharmaceutical plan a phase II in Non-small cell lung cancer (Combination therapy, Late-stage disease, Metastatic disease) in China (PO) in August 2021 (NCT04846634) Updated 15 Sep 2021 |
15 Apr 2021 | Trial Update | Akeso initiates enrollment in a phase Ib/II trial for Non-small cell lung cancer (Combination therapy, First line therapy, Late stage disease, Metastatic disease, Second line therapy or greater disease) in China, before April 2021 [16] (NCT04646330) Updated 25 Nov 2021 |
13 Apr 2021 | Phase Change - II | Phase-II clinical trials in Glioblastoma (Late-stage disease) in China (PO) (NCT04822805) Updated 24 Nov 2021 |
01 Jan 2021 | Phase Change - II | Phase-II clinical trials in Triple-negative-breast-cancer (Neoadjuvant therapy, Early-stage disease, Combination therapy) in China (PO) (ChiCTR2100043027) [26] Updated 13 Feb 2023 |
28 Dec 2020 | Phase Change - II | Phase-II clinical trials in Small cell lung cancer (Combination therapy, Second-line therapy or greater, In adults, In the elderly) in China (PO) (NCT05001971) Updated 08 Jul 2023 |
02 Dec 2020 | Trial Update | Chia Tai Tianqing Pharmaceutical Group plans a phase 0 trial for catequentinib in combination with irinotecan for Breast cancer (Late-stage disease, Combination therapy, Second-line therapy or greater) in China (IV) in September 2020 (ChiCTR2000037448) Updated 02 Dec 2020 |
01 Dec 2020 | Trial Update | Akeso plans a phase Ib/II trial for Non-small cell lung cancer (Combination therapy, First line therapy, Late stage disease, Metastatic disease, Second line therapy or greater disease) in China (NCT04646330), Updated 01 Dec 2020 |
04 Nov 2020 | Trial Update | Chia Tai Tianqing Pharmaceutical Group initiates a phase II trial for Non-small cell lung cancer (Combination therapy, Late-stage disease, Metastatic disease, Second-line therapy or greater) in China (NCT04619563) Updated 24 Nov 2020 |
19 Oct 2020 | Trial Update | Shandong Cancer Hospital plans a phase II trial for Cervical cancer (Combination therapy, Metastatic disease, Late-stage disease, Second-line therapy or greater) in China (ChiCTR2000037497) Updated 02 Dec 2020 |
19 Sep 2020 | Scientific Update | Efficacy and adverse events data from the phase II/III ALTER01032 trial in Thyroid cancer presented at the 45th European Society for Medical Oncology Congress (ESMO-2020) [62] Updated 13 Oct 2020 |
19 Sep 2020 | Scientific Update | Efficacy and adverse event data from the phase II ALTER1202 trial in Small cell lung cancer presented at the 45th European Society for Medical Oncology Congress (ESMO-2020) [102] Updated 08 Oct 2020 |
01 Jul 2020 | Trial Update | Phase-I/II clinical trials in Ovarian cancer (Combination therapy, In adults, In the elderly, Second-line therapy or greater) in China (IV) (NCT04236362) Updated 09 Jul 2020 |
03 Jun 2020 | Phase Change - II | Phase-II clinical trials in Cholangiocarcinoma (Metastatic disease, Combination therapy, Inoperable/Unresectable, Second-line therapy or greater) in China (PO) (NCT04207463) Updated 26 Jun 2020 |
03 Jun 2020 | Phase Change - II | Phase-II clinical trials in Colorectal cancer (Metastatic disease, Recurrent, Combination therapy, Inoperable/Unresectable) in China (PO) (NCT04207463) Updated 26 Jun 2020 |
03 Jun 2020 | Phase Change - II | Phase-II clinical trials in Gastric cancer (Recurrent, Metastatic disease, Combination therapy) in China (PO)(NCT04207463) Updated 26 Jun 2020 |
03 Jun 2020 | Phase Change - II | Phase-II clinical trials in Neuroendocrine tumours (Late-stage disease, Combination therapy) in China (PO) (NCT04207463) Updated 26 Jun 2020 |
03 Jun 2020 | Phase Change - II | Phase-II clinical trials in Urogenital cancer (Metastatic disease, Late-stage disease, Combination therapy, Inoperable/Unresectable) in China (PO) (NCT04207463) Updated 26 Jun 2020 |
29 May 2020 | Scientific Update | Interim efficacy and adverse events data from a phase II trial in liver cancer presented at the 56th Annual Meeting of the American Society of Clinical Oncology (ASCO-2020) [90] Updated 10 Aug 2021 |
29 May 2020 | Scientific Update | Efficacy data from the phase II/III ALTER0203 trial in Soft tissue sarcoma presented at the 56th Annual Meeting of the American Society of Clinical Oncology (ASCO-2020) [47] Updated 03 Jul 2020 |
29 May 2020 | Scientific Update | Interim pharmacodynamics data from a phase IIb/III trial in thyroid cancer presented at the 56th Annual Meeting of the American Society of Clinical Oncology (ASCO-2020) [65] Updated 13 Jun 2020 |
29 May 2020 | Scientific Update | Interim efficacy data from a phase IIb/III trial in thyroid cancer presented at the 56th Annual Meeting of the American Society of Clinical Oncology (ASCO-2020) [66] Updated 13 Jun 2020 |
29 May 2020 | Scientific Update | Efficacy and adverse events data from a phase II trial in Bone cancer presented at the 56th Annual Meeting of the American Society of Clinical Oncology(ASCO-2020) [96] Updated 10 Jun 2020 |
13 May 2020 | Trial Update | Chia Tai Tianqing Pharmaceutical plans a phase III trial for Gastric and Oesophageal cancer (Combination therapy, Late-stage disease, Metastatic disease, First-line therapy) in China (PO) in May 2020 (NCT04385550) Updated 10 Aug 2021 |
09 May 2020 | Phase Change - II | Phase-II clinical trials in Head and neck cancer (Combination therapy, Late-stage disease, Metastatic disease, Second-line therapy or greater, Recurrent) in China (PO) (NCT04203719) Updated 09 Jul 2020 |
16 Apr 2020 | Trial Update | Chia Tai Tianqing Pharmaceutical plans a phase III trial for Liver cancer (Combination therapy, Second line treatment of greater, Late-stage disease) in China (PO) in May 2020 (NCT04344158) Updated 10 Aug 2021 |
13 Apr 2020 | Trial Update | Chia Tai Tianqing Pharmaceutical Group initiates a phase II ALTER-H-004 trial in Liver cancer in China (NCT04213118) Updated 24 Apr 2020 |
30 Mar 2020 | Phase Change - III | Phase-III clinical trials in Non-small cell lung cancer (Late-stage disease, Combination therapy, Monotherapy, Inoperable/Unresectable, Second-line therapy or greater) in China (PO) (NCT04325763) Updated 17 Jul 2020 |
30 Mar 2020 | Trial Update | Chia Tai Tianqing Pharmaceutical Group plans a phase III trial for Non-small-cell lung cancer (Combination therapy, Late-stage disease, Inoperable/Unresectable, Second-line therapy or greater) in China in April 2020 (NCT04325763) Updated 17 Jul 2020 |
12 Mar 2020 | Phase Change - II | Phase-II clinical trials in Fallopian tube cancer (Combination therapy, Recurrent, Second-line therapy or greater) in China (PO) (ChiCTR2000030726) Updated 23 Jun 2020 |
12 Mar 2020 | Phase Change - II | Phase-II clinical trials in Ovarian cancer (Combination therapy, Recurrent, Second-line therapy or greater) in China (PO) (ChiCTR2000030726) Updated 23 Jun 2020 |
12 Mar 2020 | Phase Change - II | Phase-II clinical trials in Peritoneal cancer (Combination therapy, Second-line therapy or greater, Recurrent) in China (PO) (ChiCTR2000030726) Updated 23 Jun 2020 |
05 Mar 2020 | Trial Update | Chia Tai Tianqing Pharmaceutical Group plans a phase II trial for Solid tumours (Late-stage disease, Combination therapy) in China (PO) in March 2020 (NCT04291248) Updated 15 Sep 2021 |
05 Mar 2020 | Trial Update | Chia Tai Tianqing Pharmaceutical Group plans a phase II trial for Solid tumours (Late-stage disease) in China (IV) in March 2020 (NCT04291248) Updated 10 Aug 2021 |
22 Jan 2020 | Trial Update | Chia Tai Tianqing Pharmaceutical Group plans a phase I/II trial for TQB 2450 in combination with anlotinib for Epithelial ovarian, Fallopian tube or Primary peritoneal cancer (Combination therapy, In adults, In the elderly, Second-line therapy or greater) (IV) in China in January 2020 (NCT04236362) Updated 09 Jul 2020 |
20 Dec 2019 | Trial Update | Chia Tai Tianqing Pharmaceutical Group plans a phase II trial for Cholangiocarcinoma (Metastatic disease, Combination therapy, Inoperable/Unresectable, Second-line therapy or greater), Colorectal cancer (Recurrent, Metastatic disease, Combination therapy, Inoperable/Unresectable), Gastric cancer (Recurrent, Metastatic disease, Combination therapy), Urogenital cancer (Metastatic disease, Late-stage disease, Combination therapy, Inoperable/Unresectable), Neuroendocrine tumours (Late-stage disease, Combination therapy) in China in January 2020 (NCT04207463) Updated 26 Jun 2020 |
18 Dec 2019 | Trial Update | Chia Tai Tianqing Pharmaceutical Group plans a phase II trial for Head, neck and chest cancer (Late-stage disease, Metastatic disease, Combination therapy) in China in January 2020 (NCT04203719) Updated 09 Jul 2020 |
01 Dec 2019 | Trial Update | Chia Tai Tianqing Pharmaceutical Group completes the phase II/III ALTER01032 trial for Thyroid cancer in China (PO) (NCT02586337) Updated 21 Oct 2020 |
28 Oct 2019 | Trial Update | Chia Tai Tianqing Pharmaceutical and Zhengda Tianqing Pharmaceutical initiates enrolment in a phase I/II trial for Non-small cell lung cancer (Combination therapy, Second-line therapy or greater, late-stage disease) in China (ChiCTR1900026273) Updated 10 Jul 2021 |
07 Oct 2019 | Phase Change - II | Phase-II clinical trials in Squamous cell cancer (Combination therapy, First-line therapy, Late-stage disease) in China (PO) (NCT04063683) Updated 23 Apr 2020 |
27 Sep 2019 | Scientific Update | Efficacy data from the phase IIb ALTER0203 trial in Soft tissue sarcoma presented at the 44th European Society for Medical Oncology Congress (ESMO-2019) [44] Updated 22 Feb 2020 |
27 Sep 2019 | Scientific Update | Safety and efficacy data from the phase II ALTER0802 study in Liver cancer presented at the 44th European Society for Medical Oncology Congress (ESMO-2019) [105] Updated 22 Feb 2020 |
27 Sep 2019 | Scientific Update | Efficacy data from the phase II ALTER1202 trial in Small cell lung cancer presented at the 44th European Society for Medical Oncology Congress (ESMO-2019) [100] Updated 21 Feb 2020 |
29 Aug 2019 | Trial Update | Chia Tai Tianqing Pharmaceutical plans a phase III trial (Combination therapy) for Non-small Cell Lung Cancer in China (NCT04073537) Updated 15 Sep 2021 |
29 Aug 2019 | Trial Update | Chia Tai Tianqing Pharmaceutical plans a phase III trial (Combination therapy) for Small cell lung cancer in China (NCT04073550) Updated 15 Sep 2021 |
08 Aug 2019 | Phase Change - III | Phase-III clinical trials in Non-small cell lung cancer (Combination therapy, Late-stage disease, Metastatic disease, Second-line therapy or greater) in China (PO, Capsule) (NCT04439890) Updated 25 Jun 2020 |
30 Jun 2019 | Licensing Status | Chia Tia Tianqing Pharmaceutical Group and Akeso Biopharma form a Joint venture for development and commercialisation of penpulimab [1] Updated 10 Aug 2021 |
21 Jun 2019 | Trial Update | Chia Tai Tianqing Pharmaceutical Group plans a phase I/II trial for Melanoma (Late-stage disease, Combination therapy, In adults, In the elderly, Second-line therapy or greater) in China (NCT03991975) Updated 15 Nov 2019 |
20 Jun 2019 | Phase Change - I | Phase-I clinical trials in Solid tumours (Combination therapy, Late-stage disease, Metastatic disease) in China (PO) (NCT03897283) Updated 30 Nov 2020 |
19 Jun 2019 | Trial Update | Advenchen Laboratories terminates a phase I/IIa trial in Endometrial cancer, Ovarian cancer and Cervical cancer (Metastatic disease, Recurrent, Second-line therapy or greater) in USA (NCT02558348) Updated 26 Jun 2019 |
11 Jun 2019 | Phase Change - I/II | Phase-I/II clinical trials in Acral lentiginous melanoma (Second-line therapy or greater, Combination therapy, Late-stage disease) in China (PO) (NCT03991975) Updated 15 Nov 2019 |
11 Jun 2019 | Trial Update | Chia Tai Tianqing Pharmaceutical initiates enrolment in a phase I trial for Non-small cell lung cancer (Combination therapy, Late-stage disease, Second-line therapy or greater) in China (IV) (NCT03910127) Updated 15 Nov 2019 |
03 Jun 2019 | Phase Change - I | Phase-I clinical trials in Non-small cell lung cancer (Combination therapy, Late-stage disease) in China (PO) (NCT03983928) Updated 21 Aug 2019 |
01 Jun 2019 | Scientific Update | Efficacy and adverse events data from a phase II/III trial in Thyroid cancer presented at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO-2019) [63] Updated 03 Jun 2019 |
31 May 2019 | Scientific Update | Efficacy and safety data from the phase IIb ALTER0203 trial in Soft tissue sarcoma presented at the 55th Annual Meeting of American Society of Clinical Oncology (ASCO-2019) [45] Updated 14 Jun 2019 |
29 May 2019 | Trial Update | Chia Tai Tianqing Pharmaceutical Group completes enrolment in its phase II/III ALTER01032 trial for Thyroid cancer in China (PO) (NCT02586337) Updated 13 Oct 2020 |
09 May 2019 | Phase Change - I | Phase-I clinical trials in Triple-negative-breast cancer (Combination therapy, Second-line therapy or greater, Metastatic disease) in China (PO) (NCT03855358) Updated 22 Jul 2021 |
06 May 2019 | Trial Update | Chia Tai Tianqing Pharmaceutical completes the ALTER1202 phase II trial in Small cell lung cancer in China (NCT03059797) Updated 21 May 2019 |
16 Apr 2019 | Trial Update | Chia Tai Tianqing Pharmaceutical Group plans a phase I trial for Non-small cell lung cancer (Late-stage disease, Combination therapy, Second-line therapy or greater) in China (NCT03910127) Updated 16 Apr 2019 |
12 Apr 2019 | Trial Update | Chia Tai Tianqing Pharmaceutical initiates enrolment in a phase II trial for Non small cell lung cancer (Late-stage disease, Metastatic disease, Inoperable/unresectable) in China (NCT03743129) Updated 12 Sep 2019 |
01 Apr 2019 | Trial Update | Chia Tai Tianqing Pharmaceutical Group plans a phase I trial in Solid tumours (Combination therapy, Late stage disease, Metastatic disease) in May 2019 (PO) (NCT03897283) Updated 30 Nov 2020 |
22 Mar 2019 | Phase Change - I | Phase-I clinical trials in Non-small cell lung cancer (Combination therapy, First-line therapy, Late-stage disease, Locally recurrent) in China (PO) (NCT03790228) Updated 09 Jul 2021 |
01 Mar 2019 | Phase Change - II | Phase-II clinical trials in Fallopian tube cancer (Late-stage disease, Second-line therapy or greater) in China (PO) (ChiCTR2000029654) Updated 23 Jun 2020 |
01 Mar 2019 | Phase Change - II | Phase-II clinical trials in Ovarian cancer (Second-line therapy or greater) in China (PO) (ChiCTR2000029654) Updated 23 Jun 2020 |
01 Mar 2019 | Phase Change - II | Phase-II clinical trials in Peritoneal cancer (Late-stage disease, Second-line therapy or greater) in China (PO) (ChiCTR2000029654) Updated 23 Jun 2020 |
01 Mar 2019 | Trial Update | Jiangsu Chia-Tai Tianqing Pharmaceutical completes the phase-II/III ALTER0703 trial in Colorectal cancer (Late-stage disease, Metastatic disease, Second-line therapy or greater) in China (PO) (NCT02332499) Updated 28 May 2019 |
15 Jan 2019 | Phase Change - II | Phase-II study in Small cell lung cancer (First-line therapy, Combination therapy, Late-stage disease) in China (PO) (ChiCTR2000035043) Updated 05 Aug 2021 |
06 Dec 2018 | Phase Change - I/II | Phase-I/II clinical trials in Non-small cell lung cancer (Combination therapy, Late-stage disease, Metastatic disease, Second-line therapy or greater) in China (PO) (NCT03706287) Updated 15 Apr 2020 |
22 Nov 2018 | Phase Change - II | Phase-II clinical trials in Liver cancer (squamous) (Combination therapy, First-line therapy, Inoperable/Unresectable) in China (PO) (NCT04172571) Updated 10 Aug 2021 |
23 Oct 2018 | Phase Change - II | Phase-II clinical trials in Gastrointestinal stromal tumours (Metastatic disease, Recurrent, Second-line therapy or greater, Late-stage disease) in China (PO) (NCT04106024) Updated 04 Oct 2019 |
16 Oct 2018 | Trial Update | Chia Tai Tianqing Pharmaceutical Group plans a phase II trial for Non-small Cell Lung Cancer (Second-lie therapy or greater, Late-stage disease) in China , (NCT03703596) Updated 17 Oct 2018 |
15 Oct 2018 | Trial Update | Chia Tai Tianqing Pharmaceutical and Hunan Cancer Hospital initiate enrolment in a phase II trial for Non-small cell lung cancer (Combination therapy, Late-stage disease, Second-line therapy or greater) in China (PO) (NCT03624309) Updated 10 Jul 2021 |
30 Sep 2018 | Trial Update | Jiangsu Chia-Tai Tianqing Pharmaceutical completes the phase-II/III ALTER01031 trial in Thyroid cancer (Late-stage disease) in China (PO) (NCT02586350) Updated 29 May 2019 |
02 Sep 2018 | Phase Change - III | Phase-III clinical trials in Nasopharyngeal cancer (Recurrent, Late-stage disease, Metastatic disease, Combination therapy, First-line therapy) in China (PO) (NCT03601975) Updated 26 Sep 2018 |
15 Aug 2018 | Trial Update | Chia Tai Tianqing Pharmaceutical completes a phase I trial in Solid tumours (Late-stage disease, Second-line therapy or greater) in China (PO) (NCT02825563) Updated 31 May 2019 |
26 Jul 2018 | Trial Update | Jiangsu Chia-tai Tianqing Pharmaceutical plans a phase III trial for Nasopharyngeal cancer (Recurrent; Late-stage disease, Combination therapy, First-line therapy, Metastatic disease) in August 2018 (PO) (NCT03601975) Updated 26 Sep 2018 |
23 Jul 2018 | Trial Update | Chia Tai Tianqing Pharmaceutical Group completes the phase II ALTER1102 trial in Squamous cell cancer (Second-line therapy or greater, Metastatic disease, Late-stage disease) in China (PO) (NCT02649361) Updated 10 Jun 2019 |
12 Jun 2018 | Trial Update | Jiangsu Chia-tai Tianqing Pharmaceutical completes a phase II trial in Soft tissue sarcoma (Second-line therapy or greater, Late-stage disease) in China (PO) Updated 17 Jul 2018 |
15 May 2018 | Trial Update | Jiangsu Chia-tai Tianqing Pharmaceutical plans a phase II trial for Bone cancers (Late-stage disease) in May 2018 , (NCT03527888) Updated 23 May 2018 |
11 May 2018 | Phase Change - Marketed | Launched for Non-small cell lung cancer (Late-stage disease, Metastatic disease, Second-line therapy or greater) in China (PO) - First global launch [2] Updated 18 May 2018 |
10 May 2018 | Phase Change - Registered | Registered for Non-small cell lung cancer (Late-stage disease, Metastatic disease, Second-line therapy or greater) in China (PO) - First global approval [2] Updated 18 May 2018 |
31 Jan 2018 | Phase Change - II | Phase-II clinical trials in Bone cancer (Recurrent, Metastatic disease, In adolescents, In adults, In the elderly, Second-line therapy or greater) in China (PO) (NCT03527888) Updated 10 Jun 2020 |
30 Jan 2018 | Phase Change - II | Phase-II clinical trials in Neuroendocrine tumours (In adults, In the elderly, Late-stage disease, Inoperable/Unresectable, Metastatic disease, Second-line therapy or greater) in China (PO) (NCT03457844) Updated 15 Mar 2018 |
22 Jan 2018 | Phase Change - II | Phase-II clinical trials in Ewing's Sarcoma (Late-stage disease, Second-line therapy or greater) in China (PO) (NCT03416517) Updated 05 Feb 2018 |
17 Aug 2017 | Other | Chemical structure information added Updated 17 Aug 2017 |
15 Aug 2017 | Phase Change - III | Phase-III clinical trials in Alveolar soft part sarcoma (Late-stage disease, Metastatic disease, Inoperable/Unresectable) in Italy and USA (PO) (NCT03016819) Updated 18 May 2018 |
15 Aug 2017 | Phase Change - III | Phase-III clinical trials in Leiomyosarcoma (Late-stage disease, Metastatic disease, Inoperable/Unresectable, Recurrent) in Italy and USA (PO) (NCT03016819) Updated 18 May 2018 |
15 Aug 2017 | Phase Change - III | Phase-III clinical trials in Synovial sarcoma (Late-stage disease, Metastatic disease, Recurrent, Inoperable/Unresectable) in Italy and USA (PO) (NCT03016819) Updated 18 May 2018 |
01 Aug 2017 | Trial Update | Jiangsu Chia-tai Tianqing Pharmaceutical completes a phase I trial for Solid tumours (Late-stage disease) in China (PO) (NCT02622932) Updated 08 May 2019 |
19 Jun 2017 | Regulatory Status | Catequentinib - Advenchen Laboratories/Jiangsu Chia Tai Tianqing Pharmaceutical receives Orphan Drug status for Soft tissue sarcoma in USA [39] Updated 08 Feb 2022 |
02 Jun 2017 | Scientific Update | Updated efficacy and adverse events data from the phase III ALTER-0303 trial in Non-small cell lung cancer presented at the 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO-2017) [5] Updated 31 Jul 2017 |
02 Jun 2017 | Scientific Update | Efficacy data from the phase II/III ALTER-0303 trial in Non small cell lung cancer presented at the 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO-2017) [6] Updated 15 Jul 2017 |
02 Jun 2017 | Scientific Update | Pharmacokinetics and safety data from a phase I trial in Ovarian and Endometrial cancer presented at the 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO-2017) [113] Updated 15 Jul 2017 |
01 Mar 2017 | Phase Change - II | Phase-II clinical trials in Small cell lung cancer (Late-stage disease, Second-line therapy or greater) in China (PO) (NCT03059797) Updated 17 Mar 2017 |
26 Feb 2017 | Trial Update | Jiangsu Chia-tai Tianqing Pharmaceutical plans the ALTER1202 phase II trial for Small cell lung cancer (Second-line therapy or greater) in China (NCT03059797) Updated 01 Mar 2017 |
09 Jan 2017 | Trial Update | Advenchen Laboratories plans the phase III APROMISS trial for Alveolar soft part sarcoma (Inoperable/Unresectable, Metastatic disease, Late-stage disease), Leiomyosarcoma and Synovial-sarcoma (Recurrent, Inoperable/Unresectable, Metastatic disease, Late-stage disease, Second-line therapy or greater) in USA (PO) (NCT03016819) Updated 13 Jan 2017 |
06 Jan 2017 | Trial Update | Jiangsu Chia-tai Tianqing Pharmaceutical completes a phase II/III trial in Non-small cell lung cancer (Late-stage disease, Metastatic disease, Second-line therapy or greater) in China (PO) (NCT02388919) Updated 10 Feb 2017 |
01 Dec 2016 | Trial Update | Chia Tai Tianqing Pharmaceutical completes phase-II clinical trials in Thyroid cancer (Late-stage disease) in China (PO) (NCT01874873) Updated 30 May 2019 |
01 Sep 2016 | Phase Change - II | Phase-II clinical trials in liver cancer in China (PO) (NCT02809534) Updated 28 Sep 2016 |
20 Jul 2016 | Phase Change - III | Phase-III clinical trials in Thyroid cancer, Thyroid cancer (Late-stage disease), Non-small cell lung cancer (Late-stage disease, Second-line therapy or greater), Gastric cancer and Colorectal cancer (Late-stage disease, Metastatic disease, Second-line therapy or greater) in China (PO) (Advenchen Laboratories pipeline, July 2016) Updated 23 Jul 2016 |
21 Jun 2016 | Trial Update | Jiangsu Chia-tai Tianqing Pharmaceutical plans the phase II ALTER0802 trial for liver cancer in China (PO) (NCT02809534) Updated 27 Jun 2016 |
01 Jun 2016 | Trial Update | Jiangsu Chia-tai Tianqing Pharmaceutical initiates a phase I trial for Solid tumours (Late-stage disease, Second-line therapy or greater) in China (PO) (NCT02825563) Updated 12 Jul 2016 |
27 Apr 2016 | Trial Update | Jiangsu Chia-tai Tianqing Pharmaceutical initiates a phase I pharmacokinetics trial for Solid tumours (Late-stage disease) in China (PO) (NCT02752516) Updated 29 Apr 2016 |
01 Jan 2016 | Phase Change - II | Phase-II clinical trials in Squamous cell cancer (Second-line therapy or greater, Metastatic disease, Late-stage disease) in China (PO) (NCT02649361) Updated 12 Jan 2016 |
02 Dec 2015 | Trial Update | Jiangsu Chia-tai Tianqing Pharmaceutical initiates a phase I pharmacokinetics trial for Solid tumours (Late-stage disease) in China (PO) (NCT02622932) Updated 29 Apr 2016 |
01 Dec 2015 | Phase Change - I/II | Phase-I/II clinical trials in Cervical cancer (Adjunctive treatment, Recurrent, Metastatic disease, Second-line therapy or greater) in USA (PO) (NCT02584478) Updated 17 Dec 2015 |
01 Dec 2015 | Phase Change - I/II | Phase-I/II clinical trials in Endometrial cancer (Adjunctive treatment, Recurrent, Metastatic disease, Second-line therapy or greater) in USA (PO) (NCT02584478) Updated 17 Dec 2015 |
01 Dec 2015 | Phase Change - I/II | Phase-I/II clinical trials in Fallopian tube cancer (Adjunctive treatment, Metastatic disease, Recurrent, Second-line therapy or greater) in USA (PO) (NCT02584478) Updated 17 Dec 2015 |
01 Dec 2015 | Phase Change - I/II | Phase-I/II clinical trials in Ovarian cancer (Adjunctive treatment, Metastatic disease, Recurrent, Second-line therapy or greater) in USA (PO) (NCT02584478) Updated 17 Dec 2015 |
01 Dec 2015 | Phase Change - I/II | Phase-I/II clinical trials in Peritoneal cancer (Adjunctive treatment, Metastatic disease, Recurrent, Second-line therapy or greater) in USA (PO) (NCT02584478) Updated 17 Dec 2015 |
01 Dec 2015 | Trial Update | Jiangsu Chia-tai Tianqing Pharmaceutical plans a phase I pharmacokinetics trial for Cancer (Late-stage disease) in China (NCT02622932) Updated 10 Dec 2015 |
01 Nov 2015 | Phase Change - I/II | Phase-I/II clinical trials in Cervical cancer (Metastatic disease, Recurrent, Second-line therapy or greater) in USA (PO) (NCT02558348) Updated 26 Nov 2015 |
01 Nov 2015 | Phase Change - I/II | Phase-I/II clinical trials in Endometrial cancer (Metastatic disease, Recurrent, Second-line therapy or greater) in USA (PO) (NCT02558348) Updated 26 Nov 2015 |
01 Nov 2015 | Phase Change - I/II | Phase-I/II clinical trials in Ovarian cancer (Metastatic disease, Recurrent, Second-line therapy or greater) in USA (PO) (NCT02558348) Updated 26 Nov 2015 |
21 Oct 2015 | Trial Update | Advenchen Laboratories plans a phase Ib/IIa trial for Endometrial cancer, Ovarian cancer, Fallopian tube caner, Peritoneal cancer or Cervical cancer (Metastatic disease, Recurrent, Second-line therapy or greater, Adjunctive treatment) in USA (PO) (NCT02584478) Updated 28 Oct 2015 |
05 Oct 2015 | Licensing Status | Advenchen Laboratories and Jiangsu Chia-tai Tianqing Pharmaceutical agree to co-develop anlotinib (now catequentinib) for Cancer (Advenchen Laboratories website, September 2015) Updated 05 Oct 2015 |
05 Oct 2015 | Trial Update | Advenchen Laboratories plans a phase Ib/IIa trial for Endometrial cancer (Metastatic disease), Ovarian cancer (Second-line therapy or greater) or Cervical cancer (Second-line therapy or greater) in USA (PO) (NCT02558348) Updated 05 Oct 2015 |
01 Oct 2015 | Trial Update | Chia Tai Tianqing Pharmaceutical completes a phase II trial in Non-small cell lung cancer (second-line therapy or greater, late-stage disease) in China (NCT01924195) Updated 02 Nov 2015 |
01 Oct 2015 | Trial Update | Jiangsu Chia-tai Tianqing Pharmaceutical completes a phase I trial in Cancer in China (NCT01833923) Updated 02 Nov 2015 |
01 Aug 2015 | Trial Update | Chia Tai Tianqing Pharmaceutical Group completes a phase II trial in Cancer (Late-stage disease, Second-line therapy or greater) in China (PO) (NCT04216082) Updated 10 Jan 2020 |
01 Jul 2015 | Phase Change - II/III | Phase-II/III clinical trials in Thyroid cancer (Late-stage disease) in China (PO) (NCT02586350) Updated 29 Oct 2015 |
01 Jul 2015 | Phase Change - II/III | Phase-II/III clinical trials in Thyroid cancer in China (PO) (NCT02586337) Updated 29 Oct 2015 |
30 Jun 2015 | Phase Change - II/III | Phase-II/III clinical trials in Gastric cancer in China (PO) (NCT02461407) Updated 10 Nov 2015 |
08 Jun 2015 | Trial Update | Jiangsu Chia-tai Tianqing Pharmaceutical plans the phase II/II ALTER0503 trial for Gastric cancer in China (NCT02461407) Updated 08 Jun 2015 |
17 May 2015 | Trial Update | Jiangsu Chia-tai Tianqing initiates enrolment in the phase II/III ALTER0203 trial in Soft tissue sarcoma (Second-line therapy or greater) in China (NCT02449343) Updated 23 May 2015 |
01 Jan 2015 | Regulatory Status | Anlotinib (now catequentinib) receives Orphan Drug status for Ovarian cancer in USA (NCT04106024) Updated 04 Oct 2019 |
01 Jan 2015 | Phase Change - II/III | Phase-II/III clinical trials in Non-small cell lung cancer (Late-stage disease, Second-line therapy or greater, Metastatic disease) in China (PO) (NCT02388919) Updated 27 Mar 2015 |
01 Dec 2014 | Phase Change - II/III | Phase-II/III clinical trials in Colorectal cancer (Late-stage disease, Metastatic disease, Second-line therapy or greater) in China (PO) (NCT02332499) Updated 09 Jan 2015 |
31 Dec 2013 | Trial Update | Jiangsu Chia-tai Tianqing Pharmaceutical initiates enrolment in a phase II trials in Renal cell carcinoma (Late-stage disease) in China (PO) (NCT02072031) Updated 06 Mar 2014 |
31 Dec 2013 | Trial Update | Jiangsu Chia-tai Tianqing Pharmaceutical initiates enrolment in a phase II pharmacodynamics trial for Non-small cell lung cancer (late-stage disease, second-line therapy or greater) in China (NCT02029209) Updated 15 Jan 2014 |
01 Dec 2013 | Phase Change - II | Phase-II clinical trials in Renal cell carcinoma (second-line therapy or greater, late-stage disease) in China (PO) (NCT02072044) Updated 05 Mar 2014 |
14 Aug 2013 | Phase Change - II | Phase-II clinical trials in Non-small cell lung cancer (second-line therapy or greater, late-stage disease) in China (PO) Updated 20 Aug 2013 |
01 Aug 2013 | Phase Change - II | Phase-II clinical trials in Cancer (Late-stage disease, Second-line therapy or greater) in China (PO) (NCT04216082) Updated 10 Jan 2020 |
01 Apr 2013 | Phase Change - II | Phase-II clinical trials in Soft tissue sarcoma (Second-line therapy or greater, Late-stage disease) in China (PO) (NCT01878448) Updated 04 Jul 2013 |
01 Apr 2013 | Phase Change - II | Phase-II clinical trials in Thyroid cancer (late-stage disease) in China (PO) Updated 04 Jul 2013 |
31 May 2011 | Phase Change - I | Phase-I clinical trials in Cancer (late-stage disease) in China (PO) (NCT01833923) Updated 14 May 2013 |
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VOLUNTARY ANNOUNCEMENT-##8220##ANLOTINIB HYDROCHLORIDE CAPSULES##8221## OBTAINS APPROVAL FOR DRUG REGISTRATION.
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A Randomized, Double-blind and Imitation, Placebo Parallel Control, Multicentre Phase III Study of TQB2450 With or Without Anlotinib as Consolidation Treatment in Subjects With Locally Advanced/Unresectable (Stage III) Non-Small Cell Lung Cancer That Have Not Progressed After Prior Concurrent/Sequential Chemoradiotherapy
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A Randomized, Double-blind, Multicenter Phase III Study of Anlotinib Hydrochloride Capsule Combined With Chemotherapy Versus Placebo Combined With Chemotherapy as First-line Treatment in Subjects With Advanced Non-squamous Cell Non-small Cell Lung Cancer
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A Registered Randomized, Double-Blind, Placebo-Controlled (2:1), Multi-Centered Clinical Trial of Anlotinib as a Treatment for Advanced Non-Small Cell Lung Cancer
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An Open, Single Arm, Multicenter, Exploratory Phase II Clinical Trial of Anlotinib Hydrochloride Capsules Combined With TQB2450 Injection in Esophageal Squamous Cell Carcinoma Patients as Postoperative Adjuvant Therapy
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A single-arm, open phase II clinical trial of Piamprizumab injection plus platinum-containing chemotherapy combined with anrotinib hydrochloride capsules in first-line treatment of persistent, recurrent or metastatic cervical cancer
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Anlotinib Plus Docetaxel Versus Docetaxel for Treatment of EGFR Wild-type Advanced Non-small-cell Lung Cancer After Disease Progression on Platinum-based Therapy : a Multicentre, Double-blind, Randomised Explorative Trial
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A Single-arm Exploratory Clinical Study of Anlotinib Hydrochloride Combined With Docetaxel in EGFR Mutations Advanced Non Small Cell Lung Cancer Patients Who Have Progressed After Targeted Therapy and Chemotherapy
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A Randomised, Open, Blank-controlled, Multi-centre Study of Anlotinib as Sequential Therapy in Patients With Unresectable NSCLC(Stage III) Who Have Not Progressed Following Definitive, Platinum-based, Concurrent Chemoradiation Therapy
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Predict Efficacy by Detecting Circulating Endothelial Cell Subsets and Blood Perfusion Parameters Changes in Vivo Tumor in the Phase II/III Study of Anlotinib in Patients With Advanced Non-small Cell Lung Cancer
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A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II Study of Anlotinib(AL3818) as Third Line Treatment in Patients With Advanced Non-small Cell Lung Cancer (ALTER0302)
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A Phase Ib/II Trial of AK104 Plus Anlotinib in Patients With NSCLC
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A Multicenter, Single-Arm, Clinical Study of TQB2450 Plus Anlotinib in EGFR-Positive Non-Small Cell Lung Cancer Patients After Failure of EGFR TKI Therapy
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Shi M, Wang L, Yu S, Yan F, Peng W, Feng J. A phase I/II study of TQ-B2450, a PD-L1 mAb, plus anlotinib in EGFR+ advanced NSCLC patients failed to prior EGFR TKI therapies. ASCO-2021 2021; abstr. e21062.
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Efficacy and Safety of Anlotinib Combined With Platinum Plus Pemetrexed in T790M Mutation Negative Metastastic Non-squamous Non-small-cell Lung Cancer After Progression on First-line EGFR TKI: a Phase II, Muti-center, Single Arm Study
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A Phase Ib, Multicenter, Randomized Study to Evaluate the Pharmacokinetics, Efficacy and Safety of TQB2450 Combined With or Without Anlotinib in Patients With Advanced Non-small Cell Lung Cancer NSCLC
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Anlotinib Combined With Pemetrexed And Carboplatin Followed by Maintenance Therapy With Anlotinib Plus Pemetrexed as the First-line Treatment in Patients With Advanced Nonsquamous NSCLC
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Wang Q, He Z, Yang X, Ma T, Yang Q, Zhang C, et al. Anlotinib combined with pemetrexed and carboplatin as first-line treatment in driver-gene negative advanced non-squamous non-small cell lung cancer: ALTER L012. ASCO-2022 2022; abstr. e21147.
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Wang Q, Yang X, Ma T, Yang Q, Zhang C, Chen Y. Anlotinib combined with pemetrexed and carboplatin as first-line treatment in advanced nonsquamous non-small cell lung cancer (NSCLC): ALTER L012. ASCO-2021 2021; abstr. e21040.
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Qi X, Liang Y, Liu J, Shi Q, Zhu K, Jiang J, et al. Phase II study of anlotinib combined with taxanes and lobaplatin in the neoadjuvant treatment of triple-negative breast cancer: Efficacy, safety and biomarker analysis from the neoALTAL trial. ESMO-2023 2023; abstr. 246P.
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To evaluate the efficacy and safety of adding anlotinib to neoadjuvant chemotherapy in patients (pts) with primary TNBC
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A Phase Ib Study of TQB2450 Injection and Anlotinib Hydrochloride Capsules to Treat Triple Negative Breast Cancer (TNBC)
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Wang J, Xu B, Sun T, Ouyang Q, Han Y, Li Q, et al. A phase Ib study of TQB2450 plus anlotinib in patients with advanced triple-negative breast cancer. ASCO-2021 2021; abstr. 1074.
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Han Y, Wang J, Sun T, Ouyang Q, Li J, Xu B. Genomic landscape and peripheral blood biomarkers of advanced triple-negative breast cancer treated with immune checkpoint blockade: An exploratory analysis of the TQB2450-Ib-07 trial. ASCO-2022 2022; abstr. 1080.
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Anlotinib Plus Chemotherapy as First-line Therapy for Gastrointestinal Tumor Patients With Unresectable Liver Metastasis: A Multi-cohort, Multi-center Clinical Trial (ALTER-G-001)
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Efficacy and Safety of Anlotinib in Patients With Advanced Gastrointestinal Stromal Tumor After Failure of Imatinib: a Prospective, Single Arm and Multicenter Trial
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AK105 With Anlotinib and Radiotherapy Adjuvant Therapy in MGMT Unmethylated Newly Diagnosed Glioblastoma: a Prospective, Open-label Single-arm, Exploratory Trial.
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A Multicenter Study of Penpulimab and Anlotinib in Combination With Nab-paclitaxel Plus Gemcitabine as First-line Therapy in Patients (Pts) With Metastatic Pancreatic Cancer: PAAG.
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Anlotinib ODD soft tissue sarcoma US FDA. Internet-Doc 2022;.
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A Multicenter, Randomized, Double-blind, Parallel-controlled Phase III Trial to Evaluate the Efficacy and Safety of Anotinib Hydrochloride Capsule Combined With Epirubicin Hydrochloride Versus Placebo Combined With Epirubicin Hydrochloride in First-line Treatment of Advanced Soft Tissue Sarcoma
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A Phase III Study of AL3818 (Anlotinib, Catequentinib) Hydrochloride Monotherapy in Subjects With Metastatic or Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma and Synovial Sarcoma
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An Open Label Post-Trial Access (PTA) of Catequentinib (AL3818, Anlotinib) Hydrochloride Mono or in Combination Therapies in Patients Who Have Completed an Advenchen Sponsored Oncology Study With AL3818 (A Compassionate Use Trial)
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Fang Z, Yao Y, Cai J, Chi Y, Wang S, Huang G, et al. The effect of treatment line on the efficacy of anlotinib hydrochloride in advanced alveolar soft part sarcoma patients. ESMO-2019 2019; abstr. 1694P.
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Tang L, Wang Y, Zhang J, Yu W, Huang Y, Yao Y. Efficacy and safety of anlotinib in advanced soft tissue sarcoma: results from one of multi-centers in a phase IIB trial (ALTER0203). ASCO-2019 2019; abstr. e22518.
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A Registered Randomized, Double-Blind, Placebo-Controlled (2:1), Multi-Centered Clinical Trial of Anlotinib as a Treatment for Soft Tissue Sarcoma
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Fang Z, Yao Y, Cai J, Chi Y, Wang S, Huang G, et al. Efficacy of anlotinib in advanced soft tissue sarcoma by age, gender, and ECOG performance status. ASCO-2020 2020; abstr. e23562.
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Anlotinib in the Treatment of Recurrent High-grade Glioma an Open-label Single-arm, Phase 2 Trials
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Dai H, Zhang M, Zhang Q, Zhao S. A phase II study of anlotinib in the treatment of recurrent high-grade glioma. ESMO-2021 2021; abstr. 357P.
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Anlotinib and Irinotecan for Advanced Ewing Sarcoma After Failure of Standard Multimodal Therapy
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Dai H, Zhang M, Zhao S, zhang Q. A phase II study of anlotinib in the treatment of recurrent high-grade glioma: Updated results. ESMO-2022 2022; abstr. 304P.
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Phase 2 Study of Anlotinib in Advanced Soft Tissue Sarcoma
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A Phase Ib, Open-label, Single Center, Non-randomized Study for Safety and Efficacy of TQB2450 Combined With Anlotinib in Patients With Advanced Mutation Positive Non-Small Cell Lung Cancer
ctiprofile -
A Multicenter Exploratory Study of Paclitaxel+Cisplatin+TQB2450 Injection Combined With or Without Anlotinib in the First-line Treatment of Advanced Esophageal Squamous Cell Carcinoma
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Wang J, Li N, Guo Y, Cheng Y, Li B, Luo S-x. TQB2450 plus anlotinib combined with paclitaxel and cisplatin as first-line treatment of advanced esophageal squamous cell carcinoma (ESCC): Update results of a single-arm, multicenter phase ? trial. ASCO-2023 2023; abstr. e16034.
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A Single-arm, Multi-center Exploratory Clinical Study of Anlotinib Combined With TQB2450 (PD-L1 Inhibitor) in the Treatment of Advanced Esophageal Squamous Cell Carcinoma
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Zhang Z, Meng X, Yang X, Hong Y-G, Xia J, Chen Y, et al. Updated results of anlotinib combined with TQB2450 (PD-L1 blockade) as first-line treatment for advanced esophageal squamous cell carcinoma (ESCC): A single-arm, multicenter, open-label phase ? clinical trial. ASCO-2023 2023; abstr. 4041.
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A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Trial to Compare the Efficacy and Safety of Anlotinib Versus Placebo in Patients With Esophageal Squamous Cell Carcinoma(ALTER1102)
ctiprofile -
Paclitaxel and DDP Combined With Anlotinib in the First-line Treatment for Patients With Advanced Esophageal Squamous Cell Carcinoma: a Single Arm, Multicentre Trial.
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Wang J, Wu T, Luo S, Li N, Hong Y, Guo Y, et al. Update results of paclitaxel and cisplatin in combination with anlotinib as first-line regimen for patients with advanced ESCC: A multicenter, single-arm, open-label phase ? clinical trial. ASCO-2021 2021; abstr. e16013.
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A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Trial to Compare the Efficacy and Safety of Anlotinib Versus Placebo in Patients With 131I-Refractory Differentiated Thyroid Cancer(ALTER01032)
ctiprofile -
Chi Y, Gao M, Zhang Y, Shi F, Cheng Y, Guo Z, et al. Anlotinib in locally advanced or metastatic radioiodine-refractory differentiated thyroid carcinoma: A randomized, double-blind, multicenter phase II trial. ESMO-2020 2020; abstr. LBA88.
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Li D, Tang PZ, Chen X, Ge M, Zhang Y, Guo Z, et al. Anlotinib treatment in locally advanced or metastatic medullary thyroid carcinoma: A multicenter, randomized, double-blind, placebo-controlled phase IIB trial. ASCO-2019 2019; abstr. 6019.
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A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Trial to Compare the Efficacy and Safety of Anlotinib Versus Placebo in Patients With Medullary Thyroid Carcinoma(ALTER01031)
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Gao M, Chi Y, Tang P, Xu Z, Zheng X, Li D, et al. Association between calcitonin and efficacy of anlotinib in medullary thyroid carcinoma: An analysis based on the ALTER01031 trial. ASCO-2020 2020; abstr. 6526.
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Gao M, Chi Y, Zheng X, Li D, Tang P, Xu Z, et al. Influence of Eastern Cooperative Oncology Group performance status (ECOG PS), tumor size and age on patient outcomes after anlotinib treatment: A subgroup analysis based on ALTER01031 trial for medullary thyroid carcinoma (MTC). ASCO-2020 2020; abstr. 6527.
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The Efficacy and Safety of Anlotinib Hydrochloride or Penpulimab In Combination With RAI in Patients With Local Advanced or Metastatic Differentiated Thyroid Cancer: A Randomized, Open-label, Exploratory Clinical Trial
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Phase 2 Study of Anlotinib in Advanced Medullary Thyroid Carcinoma
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A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Trial to Compare the Efficacy and Safety of Anlotinib Versus Placebo in Patients With Gastric Cancer(ALTER0503)
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Phase Ib Study to Evaluate the Safety and Efficacy of TQB2450 (PD-L1 Antibody) Combined With Anlotinib in Subjects With Advanced Acral Malignant Melanoma
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Mao L, Chen Y, Du Y, Bai X, Dai J, Lin J, et al. Phase Ib study of anlotinib in combination with anti-PD-L1 ab (TQB2450) in patients with advanced acral melanoma. ASCO-2022 2022; abstr. e21543.
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A Randomized, Double-blind, Placebo-controlled, Multicenter Phase 3 Study of Anlotinib Hydrochloride Capsules Combined With Penpulimab Injection in Patients With High Risk of Relapse After Radical Surgery or Ablation of Hepatocellular Carcinoma (HCC).
ctiprofile -
A Randomized, Open-label, Parallel Controlled, Multi-center Phase III Study of Anlotinib Hydrochloride Capsule Combined With Chemotherapy as First-line Treatment in Subjects With RAS/BRAF Wild Metastatic Colorectal Cancer
ctiprofile -
Phase III Randomized Trial of Anlotinib Plus Gemcitabine/Cisplatin Vesus Placebo Plus Gemcitabine/Cisplatin in Previous Untreated Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma
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Randomized,Double-blind,Placebo-controlled,Multicenter Study to Compare the Efficacy and Safety of Anlotinib Plus BSC Versus Placebo Plus BSC in Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies(ALTER0703)
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A Phase II, Open, Single-arm, Multi-cohort, Multicenter Study of Anlotinib and AK105 Injection in Subjects With Advanced Head, Neck and Chest Cancer
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Zhang C, Yang S, Chen J, Wu H, Wang J, Li Y, et al. Penpulimab plus anlotinib as second-line treatment for the small cell lung cancer after failure of platinum-based systemic chemotherapy. ASCO-2021 2021; abstr. 8568.
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Zhang C, Shi Y, Liu Q, Wu K, Li X, Cui J, et al. Analysis of penpulimab plus anlotinib in pleural mesothelioma or thymic carcinoma patients who have received at least one line of chemotherapy. ESMO-2022 2022; abstr. 1632P.
Available from: URL: https://oncologypro.esmo.org/meeting-resources/esmo-congress/analysis-of-penpulimab-plus-anlotinib-in-pleural-mesothelioma-or-thymic-carcinoma-patients-who-have-received-at-least-one-line-of-chemotherapy -
Shi Y, Gao L, Tian Y, Chen J, Wang J, Bai C, et al. Efficacy and safety of penpulimab plus anlotinib in recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC): A phase II study. ESMO-2021 2021; abstr. 908P.
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Zhang C, Sun Y, Wang J, Liu Z, Su H, Chen J, et al. A phase II study cohort of penpulimab plus anlotinib in patients with recurrent or metastatic non-squamous cell carcinomas of head and neck. ASCO-2023 2023; abstr. e18013.
Available from: URL: https://meetings.asco.org/abstracts-presentations/218645 -
A Phase II, Open, Single-arm, Multi-cohort, Multicenter Study of Anlotinib and AK105 Injection in Subjects With Gastrointestinal Tumors, Urinary System Tumors, Neuroendocrine Tumors
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Sun Y, Qu W, Sun M, Zhou J, Bi X, Zhou A. ALTN-AK105-II-02 cohort 4: A phase II study of penpulimab plus anlotinib in patients (pts) with previously treated locally advanced or metastatic urothelial carcinoma (UC). ESMO-2022 2022; abstr. 1743P.
Available from: URL: https://link.adisinsight.com/Wr7z8 -
An Open-label, Single Arm, Phase II Trial of Niraparib in Combination With Anlotinib in Patients With Platinum-resistant Recurrent Ovarian Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer (Ovarian Cancer)
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An Open, Single Arm,Multicenter Clinical Trial of Anlotinib Combined With Transcatheter Arterial Chemoembolization for Adjuvant Therapy in Patients With High Risk of Recurrence After Resection of Advanced Hepatocellular Carcinoma
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Wu Z, Wang Z, Du X, Zhang L. ALTER-H-004: A phase II study of anlotinib combined with TACE as adjuvant therapy in hepatocellular carcinoma patients at high risk of post-surgery recurrence. ESMO-2020 2020; abstr. 1018TiP.
Available from: URL: https://www.sciencedirect.com/science/article/pii/S0923753420411305 -
Wu Z, Wang Z, Zhang L, Song X, Du X, Tan K. Update results from ALTER-H004 study: Anlotinib combined with TACE as adjuvant therapy in hepatocellular carcinoma patients at high risk of recurrence after surgery-A single-arm, multicenter, phase II clinical trial. ASCO-2022 2022; abstr. e16120.
Available from: URL: https://meetings.asco.org//abstracts-presentations/211890 -
Wu Z, Wang Z, Zhang L, Song X. Updated results from ALTER-H004 trial: Anlotinib combined with TACE as adjuvant therapy for patients with hepatocellular carcinoma at high risk of recurrence after surgery-A single arm, multi-center, phase II clinical trial. ASCO-2023 2023; abstr. e16222.
Available from: URL: https://meetings.asco.org/abstracts-presentations/222116 -
A Phase Ib Clinical Study to Evaluate the Efficacy and Safety of TQB2618 Injection Combined With Penpulimab Injection and Anlotinib Hydrochloride Capsules as First-line Treatment for Advanced Hepatocellular Carcinoma.
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An Open-Label Multi-Center Phase Ib/II Study of the Combination of AK105 and Anlotinib Hydrochloride in the First-Line Treatment of Patients With Unresectable Hepatocellular Carcinoma
ctiprofile -
Jiao SC, Bai L, Dong J, Bai C, Hu C, Shen L, et al. Clinical activity and safety of penpulimab (Anti-PD-1) with anlotinib as first-line therapy for advanced hepatocellular carcinoma (HCC). ASCO-2020 2020; abstr. 4592.
Available from: URL: https://meetinglibrary.asco.org/record/186439/abstract -
Chen J, Wei W, Zheng L, Li H, Feng Y, Wan T, et al. Anlotinib plus pemetrexed as a further treatment for patients with platinum-resistant ovarian cancer: A single-arm, open-label, phase II study. ASCO-2021 2021; abstr. 5533.
Available from: URL: https://meetinglibrary.asco.org/record/197856/abstract -
Efficiency and safety of Anlotinib in platinum resistant or refractory ovarian cancer: a prospective, single arm, single center, exploratory phase 2 clinical trial
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Wang H, Shen W, Shan B. Anlotinib in patients with recurrent platinum-resistant or refractory ovarian carcinoma: A prospective, single-arm, single-center, phase II clinical study. ASCO-2021 2021; abstr. e17524.
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Wang H, Shan B, Shen W. Anlotinib in patients with recurrent platinum-resistant or -refractory ovarian carcinoma: A prospective, single-arm, single-center, phase II clinical study. ESMO-2021 2021; abstr. 730P.
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A Single Group, Open Label, Multi-center Clinical Trial to Assess the Efficacy and Safety of Anlotinib in Patients With Gastroenteropancreatic Neuroendocrine Tumor G3
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Tang L, Niu X, Wang Z, Cai Q, Tu C, Fan Z, et al. A phase II study of anlotinib in treating patients with relapsed or metastatic primary malignant bone tumor. ASCO-2020 2020; abstr. 11525.
Available from: URL: https://meetinglibrary.asco.org/record/186760/abstract -
A Single-Arm, Open-Label, Multicenter Clinical Trial With Anlotinib Hydrochloride Capsule for Primary Malignant Bone Tumors With Recurrence and Distant Metastases
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Anlotinib Plus Penpulimab for the Treatment of Sensitive Relapsed Small-Cell Lung Cancer: a Multicenter, Single-arm, Explorative Trial
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Yang N, Zhang Y, Zeng L, Yang H, Zhou C, Liu L, et al. The combination therapy of anlotinib and penpulimab for the treatment of small cell lung cancer after platinum-based chemotherapy: Results of a phase II exploratory study. ASCO-2023 2023; abstr. e20628.
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A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Trial to Compare the Efficacy and Safety of Anlotinib Versus Placebo in Patients With Small Cell Lung Cancer(ALTER1202)
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Liu Y, Cheng Y, Wang Q, Li K, Shi J, Wu L, et al. Effect of anlotinib in advanced small cell lung cancer patients with pleural metastases/pleural effusion: A subgroup analysis from a randomized, double-blind phase II trial (ALTER1202). ESMO-2020 2020; abstr. 1787P.
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Kong T, Chen L, Duan F, Hou X, Wang L, Zhou H, et al. Efficacy and safety analysis of anlotinib combined with etoposide plus cisplatin/carboplatin as first-line therapy for extensive-stage small cell lung cancer (SCLC): The final results from a phase II single-arm trial. ASCO-2021 2021; abstr. 8560.
Available from: URL: https://meetinglibrary.asco.org/record/198958/abstract -
A single arm, monocentric and exploratory analysis of the first-line treatment of extensive small cell lung cancer with enrotinib combined with EP / EC regimen
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Zhou A, Sun Y, Zhang W, Jiang Z, Chen B, Zhao J, et al. Anlotinib for advanced hepatocellular carcinoma: Interim results from the phase II ALTER0802 study. ESMO-2019 2019; abstr. 751P.
Available from: URL: https://academic.oup.com/annonc/article/30/Supplement_5/mdz247.077/5576825 -
A Single Group, Open Label, Single-center Clinical Trial to Assess the Efficacy and Safety of Anlotinib in Patients With Hepatocellular Carcinoma (ALTER0802)
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A Phase II Study of Anlotinib(AL3818) in Patients With Advanced Renal Cell Carcinoma(RCC) That Have Failed Or Are Intolerant To TKIs Therapy
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A Randomized, Positive-controlled, Multicenter, Phase II Study of Anlotinib (AL3818) Hydrochloric Capsule in Patients With Advanced Renal Cell Carcinoma (RCC)
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A Single Center, Single-arm, Phase II Study of Anlotinib in Subjects With Advanced Malignancy
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A Phase Ib, Single Arm, Open Study of TQB2450 Combined With Anlotinib in Subjects With Relapsed / Refractory Ovarian Cancer
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Lan C, Zhao J, Yang F, Li R, Huang Y, Wang J, et al. Anlotinib in combination with TQB2450 in patients with recurrent ovarian cancer (ACTION): A multicenter, single-arm, open-label, phase Ib trial. ASCO-2021 2021; abstr. 5557.
Available from: URL: https://meetinglibrary.asco.org/record/197606/abstract -
A Phase 1/2a Evaluation of the Safety, Pharmacokinetics and Efficacy of AL3818, a Dual Receptor Tyrosine Kinase Inhibitor, in Subjects With Recurrent or Metastatic Endometrial, Ovarian or Cervical Cancer (AL3818-US-001)
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Werner TL, Kannapel E, Chen J, Chen M, Cohen AL. Safety and PK results from a phase Ib study of AL3818 (anlotinib) hydrochloride in subjects with ovarian, cervical, and endometrial cancers. ASCO-2017 2017; abstr. e17071.
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A Phase 1/2a/3 Evaluation of the Safety and Efficacy of Adding AL3818 (Anlotinib, INN: Catequentinib), a Dual Receptor Tyrosine Kinase Inhibitor, to Standard Platinum-Based Chemotherapy in Subjects With Recurrent or Metastatic Endometrial, Ovarian, Fallopian, Primary Peritoneal or Cervical Carcinoma
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Phase Ib Study of TQB2450 Combined With Anlotinib in Patients With Advanced Solid Tumors
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Phase I Additional Study of Anlotinib on Pharmacokinetics to Assess the Effect of High Fat Diet in Advanced Cancer Patients
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Phase I Additional Study of Tolerance and Pharmacokinetics of Anlotinib in Patients With Advanced Solid Tumors
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A Phase 1, Open-label Study to Investigate the Absorption, Metabolism and Excretion of [14C] Anlotinib in Patients With Advanced Cancer Patients
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A Phase I Study of Anlotinib on Tolerance and Pharmacokinetics
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Cheng Y, Cui H, Wu C, Wang Y, Zhang T, Xin Y, et al. A phase Ib study of TQ-B2450 plus anlotinib in patients with advanced solid tumor. ASCO-2020 2020; abstr. 3065.
Available from: URL: https://meetinglibrary.asco.org/record/188591/abstract -
Cheng Y, Cui H, Wu C, Wang Y, Zhang T, Xin Y, et al. A phase Ib study of TQB2450 in combination with anlotinib in patients with advanced solid tumour. ESMO-2020 2020; abstr. 532MO.
Available from: URL: https://www.sciencedirect.com/science/article/pii/S0923753420406428
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