Life sciences · Phase 1/2 Trial
ClinicalTrials.gov · September 17, 2026
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Phase 1/2 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT04152499). This is a study registration, not published results. Lead sponsor: Klus Pharma Inc.. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 1410 participants (ACTUAL). Conditions: Epithelial Ovarian Cancer, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Urothelial Carcinoma, Non-Small Cell Lung Cancer, Small-Cell Lung Cancer, Endometrial Carcinoma, Head and Neck Squamous Cell Carcinoma, Breast Cancer, Cervical Cancer. Interventions: DRUG: SKB264. Primary outcome measures: Phase I: Maximum Tolerated Dose (MTD) and Recommended Doses for Expansion (RDEs) , Assess up to 12 months; Phase II: Objective Response Rate (ORR) , From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months. Brief summary: A Phase I-II, First-in-Human Study of SKB264 (Sac-TMT; MK-2870) in Patients with Locally Advanced Unresectable/Metastatic Solid Tumors who are refractory to Available Standard Therapies. Patient must have historically documented, incurable, locally advanced or metastatic cancer that are refractory to standard therapies of one of the following types: 1. Triple negative breast cancer 2. Epithelial ovarian cancer 3. Non-small cell lung cancer 4. Gastric adenocarcinoma/Gastroesophageal junction adenocarcinoma 5. Small cell lung cancer 6. HR+/ HER2-breast cancer 7. Head and neck squamous cell carcinoma 8. Endometrial carcinoma 9. Urothelial carcinoma 10. Cervical cancer