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Brief Title: Disitamab Vedotin in the Treatment With HER2- Expression, Subjects With Locally Advanced or Metastatic Castration-resistant Prostate Cancer
Official Title: A Multicenter Open Phase II to Evaluate the Safety, Efficacy and Pharmacokinetic Characteristics of Disitamab Vedotin in the Treatment With HER2- Expression, Subjects With Locally Advanced or Metastatic Castration-resistant Prostate Cancer
Study ID: NCT06227156
Brief Summary: The purpose of this study is to evaluate the effectiveness of Disitamab Vedotin in the treatment of subjects with locally advanced or metastatic castration-resistant prostate cancer.
Detailed Description: This is a Multicenter Open Phase II to Evaluate the Safety, Efficacy and Pharmacokinetic Characteristics of Disitamab Vedotin in the Treatment With HER2- Expression, Subjects with locally advanced or metastatic castration-resistant prostate cancer. The study plans to enroll 40 subjects with locally advanced or metastatic CRPC with HER2 expression (IHC 1+ and above) who have been treated with androgen deprivation therapy and novel hormone therapy. Eligible subjects were enrolled and received RC48 intravenous infusion at a dose of 2.0 mg/kg every 2 weeks. Subjects received medication until disease progression, intolerable toxicity, active withdrawal, death, or study termination by the sponsor.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Peking University First Hospital, Beijing, Beijing, China
The Third Medical Center of PLA General Hospital, Beijing, Beijing, China
Beijing Cancer Hospital, Beijing, Beijing, China
Name: Jianmin Fang, Ph.D
Affiliation: RemeGen Co., Ltd.
Role: STUDY_DIRECTOR