drugset / Trial / NCT07660211

Clinical Evaluation of 177Lu-PSMA-VG01 Injection in Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC)

NCT07660211 ↗

Phase 1 Recruiting 10 enrolled VitsGen Therapeutics Inc.
NaSingle-groupOpen-labelTreatment

Summary

This is a phase I clinical trial conducted in participants with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC). After confirmation of PSMA positivity, participants receive intravenous administration of 177Lu-PSMA-VG01. The objectives are: to evaluate the biodistribution, radiation dosimetry, safety and tolerability of 177Lu-PSMA-VG01 in participants; and to assess the pharmacokinetics (PK), preliminary anti-tumor activity, and in vivo stability of 177Lu-PSMA-VG01 in participants.

Timeline

Start
2026-06-16
Primary completion
2027-05-06
Completion
2029-05-06

Drugs

EvaluationDrugModalityDoseRoute
Subject 177Lu-PSMA-VG01 Unknown — Intravenous