Trial Profile
A Multi-Center, Open Label Phase Ib/II Clinical Study to Evaluate JS001 in Patients With Advanced Gastric Adenocarcinoma, Esophageal Squamous Cell Carcinoma, Nasopharyngeal Carcinoma and Head and Neck Squamous Cell Carcinoma
Status:
Active, no longer recruiting
Phase of Trial:
Phase I/II
Latest Information Update: 07 Feb 2024
Price :
$35
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At a glance
- Drugs Toripalimab (Primary) ; Capecitabine; Cisplatin; Docetaxel; Fluorouracil; Gemcitabine; Oxaliplatin; Paclitaxel
- Indications Adenocarcinoma; Carcinoma; Gastric cancer; Head and neck cancer; Nasopharyngeal cancer; Oesophageal cancer; Squamous cell cancer
- Focus Biomarker; Registrational; Therapeutic Use
- Acronyms POLARIS-02
- Sponsors Shanghai Junshi Biosciences
- 01 Feb 2024 According to a Junshi Biosciences Media Release, the Singapore Health Sciences Authority (HSA) has also granted priority review designation to the NDA. The NDA is supported by results from JUPITER-02 and POLARIS-02 studies. In Singapore, the NDA application was accepted by the HSA in January 2024.
- 01 Feb 2024 According to a Junshi Biosciences Media Release, company announced that the Singapore Health Sciences Authority (HSA) had accepted the New Drug Application (NDA) for toripalimab, both in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent LA NPC, and as a single agent for the treatment of adults with recurrent, unresectable, or metastatic NPC as second line therapy.
- 11 Dec 2023 According to a Coherus BioSciences media release, based on the results of this study National Comprehensive Cancer Network (NCCN) has updated the clinical practice guidelines for nasopharyngeal carcinoma (NPC) to include LOQTORZI™ (toripalimab-tpzi) as a preferred, category 1 first-line treatment option for adults with metastatic or recurrent locally advanced NPC when used in combination with cisplatin and gemcitabine.