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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

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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: Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 16 Apr 2026

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At a glance

  • Drugs Sacituzumab Tirumotecan (Primary) ; Famotidine; Nizatidine; Paracetamol; Ranitidine
  • 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 MK-2870-001
  • Sponsors Klus Pharma

Most Recent Events

  • 28 Nov 2025 According to a Sichuan Kelun-Biotech Biopharmaceutical media release, as of the February 17, 2025 data cutoff, 49 participants had been treated with sac-TMT.
  • 28 Nov 2025 Results presented in a Sichuan Kelun-Biotech Biopharmaceutical Media Release
  • 28 Nov 2025 According to a Sichuan Kelun-Biotech Biopharmaceutical media release, efficacy and safety results of cohort 9 from this trial for advanced or metastatic urothelial carcinoma (UC) patients has been published in the journal of Annals of Oncology

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