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A Phase I-II, First-in-Human Study of SKB264 in Patients With Locally Advanced Unresectable /Metastatic Solid Tumors Who Are Refractory to Available Standard Therapies

Trial Profile

A Phase I-II, First-in-Human Study of SKB264 in Patients With Locally Advanced Unresectable /Metastatic Solid Tumors Who Are Refractory to Available Standard Therapies

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 04 Jan 2025

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At a glance

  • Drugs Sacituzumab Tirumotecan (Primary)
  • Indications Adenocarcinoma; Advanced breast cancer; Bladder cancer; Carcinoma; Cervical cancer; Endometrial cancer; Gastric cancer; Head and neck cancer; HER2 negative breast cancer; HER2 positive breast cancer; Non-small cell lung cancer; Oesophageal cancer; Ovarian cancer; Pancreatic cancer; Peritoneal cancer; Small cell lung cancer; Solid tumours; Squamous cell cancer; Triple negative breast cancer; Urogenital cancer
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Acronyms A264
  • Sponsors Klus Pharma
  • Most Recent Events

    • 03 Dec 2024 According to a Merck & Co Media Release, U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to sacituzumab tirumotecan (sac-TMT) for the treatment of patients with advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC), based on data from the Phase 2 expansion cohort of Phase 1/2 study, as well as data from two parts of a Phase 2 study.
    • 28 Sep 2024 Results presented in a Sichuan Kelun-Biotech Biopharmaceutical media release.
    • 28 Sep 2024 According to a Sichuan Kelun-Biotech Biopharmaceutical media release, On the morning of September 28, Dr. Zhuo Yang from Liaoning Provincial Cancer Hospital shared the results of safety and efficacy of sac-TMT in pts with previously treated advanced endometrial carcinoma (EC) and ovarian cancer (OC) from a Phase 2 Study.

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