Phase II Multicenter Study of YL201 Safety and Effectiveness in Men With Metastatic Castration-Resistant Prostate Cancer

What this Trial Is About

Researchers are evaluating YL201, a drug being studied for men with metastatic castration-resistant prostate cancer mCRPC, in an open-label, multicenter phase II trial in China. The study aims to assess the safety, effectiveness, and how the body processes YL201 in this patient group. This research includes patients who have progressed despite prior hormone therapies and may have received limited chemotherapy. The study is sponsored by MediLink Therapeutics Suzhou Co., Ltd. Participants will receive YL201 through intravenous infusion every three weeks, with dosing schedules varying between once or twice per cycle depending on the group. There are multiple dosing cohorts testing different amounts and frequencies of YL201 to find the best dose for future studies. The trial includes about 100 patients divided into initial groups receiving specific doses and a later group receiving the recommended dose and administration method. During the study, participants will undergo regular assessments including imaging scans to measure tumor response and progression, blood tests to monitor drug levels and side effects, and evaluations of prostate-specific antigen PSA levels. Researchers will track objective response rates, progression-free survival, and safety outcomes over approximately 36 months. Tumor tissue analysis for B7H3 expression and monitoring for adverse events will also be part of the study. Participants must comply with scheduled visits and procedures throughout the trial.

A Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Patients With mCRPC