Castration-resistant Prostate Cancer Clinical Trial
Official title:
A Multicenter Open Phase Ib to Evaluate the Safety, Efficacy and Pharmacokinetic Characteristics of Disitamab Vedotin in the Treatment With HER2- Expression, Gene Amplification or Mutation Metastatic Castration-Resistant Prostate Cancer
The purpose of this study is to evaluate the safety and tolerance of Disitamab Vedotin in subjects with metastatic Castration-resistant prostate cancer.
This is an open-label, multicenter, Phase Ib Study designed to evaluate safety and efficacy of Disitamab Vedotin in the Treatment of Subjects with HER2- expression, gene amplification or mutation Metastatic Castration-Resistant Prostate Cancer. The study was designed with 2 cohorts, cohort 1 was planned to enroll 40 subjects who had not received paclitaxel at the mCRPC stage, and cohort 2 was planned to enroll 20 subjects who had received at least 1 paclitaxel at the mCRPC stage. Subjects received the experimental drug until disease progression, untolerance of toxicity, withdrawal, death, or discontinuation of the study by the Sponsor. After completion of study treatment (calculated from the date of the determination to discontinue treatment), all subjects will be followed for survival every 3 months (±14 days) until death, loss to follow-up, withdrawal of consent, or discontinuation of the study by Sponsor. ;
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