Trial Details

A Multicenter, Open-label, Phase 2, Basket Study to Evaluate the Efficacy and Safety of SKB264 in Combination With Pembrolizumab in Subjects With Selected Solid Tumors

NCT05642780

RECRUITING

DESCRIPTION

The purpose of this study is to evaluate the efficacy and safety of combination of SKB264 and Pembrolizumab in patients with selected solid tumors including cervical cancer, urothelial cancer, ovarian cancer, prostate cancer,advanced endometrial cancer.

CONDITIONS

ELIGIBILITY CRITERIA

• Inclusion Criteria
• : 1. Subjects with Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 . 2. Subjects with expected survival ≥ 3 months. 3. Cohort A: Subjects with recurrent or metastatic cervical cancer 4. Cohort B: Subjects with locally advanced or metastatic urothelial carcinoma 5. Cohort C: Subjects with recurrent ovarian cancer 6. Cohort D: Subjects with metastatic prostate cancer 7. Subjects have at least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. 8. Subjects able to provide tumor blocks or slides for biomarker test. 9. Subjects have relatively good organ function and bone marrow function. 10. Subjects must have recovered from all toxicities from previous therapy with the exception of toxicities not considered a safety risk. 11. Contraceptive use by men and women must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. 12. Subject is capable of giving signed informed consent. 13. Cohort E: Subjects with advanced endometrial cancer.