NCT07093866

Efficacy and Safety of Disitamab Vedotin Plus Abiraterone for Metastatic Castration-Resistant Prostate Cancer：a Phase II Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Academic / Other
• Sex: Male
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

• mCRPC

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-07-20
• Primary completion: 2026-12-30
• Completion: 2027-12-30
• First posted: 2025-07-30
• Last updated: 2025-07-30

Locations

1 site across 1 country: China