Metastatic Castration-resistant Prostate Cancer (mCRPC) Clinical Trial
Official title:
A Multicenter, Open-Label, Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Patients With Metastatic Castration-Resistant Prostate Cancer
This is a multicenter, open-label, Phase 2 study. The study will enroll subjects with metastatic castration-resistant prostate cancer (mCRPC) previously treated with at least 1 prior line of novel hormone therapy (NHT). NHT includes abiraterone, enzalutamide, apalutamide, darotamide, or rezvilutamide. Subjects must have received no more than 2 prior lines of taxane-containing regimen. This study consists of two parts. Part 1 will preliminarily assess the efficacy and tolerability of YL201 at 2.0, 2.4, or 2.8 mg/kg with approximately 40 subjects. Part 2 will further assess the efficacy and safety of YL201 at the recommended expansion dose (RED) obtained from Part 1 with up to 60 subjects. YL201 will be administered intravenously (IV) on Day 1 of each 3-week cycle until criteria of treatment discontinuation are met. Subjects will undergo regular testing for signs of disease progression (PD) using computed tomography (CT) scan, magnetic resonance imaging (MRI), bone scan, and prostate-specific antigen (PSA) blood test. Routine examinations and blood tests will be performed and evaluated by the study physician.
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