NCT07537010

3D1015 Injection for Patients With mCRPC

Safety, Dosimetry, and Preliminary Efficacy of 3D1015 Injection in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC): An Open-Label Clinical Study

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: Chunjing Yu · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This open-label clinical study investigates 3D1015 Injection (Lu 177-PSMA-3D1015) in adult males with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC). Participants will receive intravenous infusions of 3D1015, with treatment regimens dynamically individualized to optimize patient safety and outcomes. The primary objectives are to assess the safety, tolerability, and dosimetry of the injection. Secondary objectives include evaluating preliminary anti-tumor efficacy and exploring the optimal dosing regimen.

Conditions

• Metastatic Castration-resistant Prostate Cancer, mCRPC

Interventions

Type	Name	Description
DRUG	Lu 177-PSMA-3D1015 Injection	3D1015 is administered intravenously at an individualized dose.

Timeline

• Start date: 2025-08-27
• Primary completion: 2027-06-30
• Completion: 2027-12-31
• First posted: 2026-04-17
• Last updated: 2026-04-17

Locations

1 site across 1 country: China