Efficacy and Safety of Disitamab Vedotin Plus Abiraterone for Metastatic Castration-Resistant Prostate Cancer:a Phase II Study
NCT07093866 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2025-07-30
Summary
This is an open-label,prospective,single-arm,phase 2 trial aims to evaluate the efficacy and safety of disitamab vedotin combined with abiraterone in patients with metastatic castration-resistant prostate cancer.
Conditions
Interventions
- DRUG
-
Disitamab Vedotin (RC48)
Disitamab Vedotin 2mg/kg is administered intravenously once every 2 weeks (1 cycle)
- DRUG
-
Abiraterone + prednisone
Abiraterone 1000mg is administered orally once a day,and prednisone 5mg is administered orally twice a day.
Sponsors & Collaborators
-
Nanjing University
collaborator OTHER -
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-07-20
- Primary Completion
- 2026-12-30
- Completion
- 2027-12-30
Countries
- China
Study Locations
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