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

Klus Pharma Inc.46 个研究点分布在 6 个国家目标入组 240 人开始时间: 2023年1月17日最近更新: 2025年10月14日

适应症

干预措施

试验速览

阶段: 2 期
状态: 进行中（未招募）
发起方: Klus Pharma Inc.
入组人数: 240
试验地点: 46
主要终点: Dose limiting toxicity (DLT) and adverse events (AEs)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

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

排除标准

•Subjects with active or untreated central nervous system (CNS) metastases and/or carcinomatous meningitis are not eligible.
•Subjects who suffer from cardiovascular diseases of clinical significance.
•Subjects with serious and/or uncontrolled concomitant diseases.
•Subjects diagnosed active hepatitis B or hepatitis C.
•Subjects have known human immunodeficiency virus (HIV) infection that is not well controlled.
•Subjects with known active tuberculosis.
•Known allergy or hypersensitivity to pembrolizumab or SKB264, or the excipients of pembrolizumab or SKB
•Subjects with history of allogeneic tissue/solid organ transplant.
•Subjects previously treated with TROP2 targeted therapy.
•Subjects who are vaccinated with live vaccine within 30 days before the first dose, or plan to be vaccinated with live vaccine during the study period.
•Subjects participating in another clinical study, unless it is an observational (non-intervention) clinical study or the follow-up period of an intervention study.
•The Investigator considers other situations that will interfere with the evaluation of the study intervention or the safety of the subjects or the interpretation of the results of the study.