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RECRUITING
NCT07660211
PHASE1

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

Sponsor: VitsGen Therapeutics Inc.

View on ClinicalTrials.gov

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.

Official title: A Phase 1, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Biodistribution, Radiation Dosimetry and Preliminary Efficacy of 177Lu-PSMA-VG01 Injection in Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Key Details

Gender

MALE

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2026-06-16

Completion Date

2029-05-06

Last Updated

2026-06-22

Healthy Volunteers

No

Interventions

DRUG

177Lu-PSMA-VG01

Treatment patients

Locations (1)

Zhong Shan Hospital Fudan University

Shanghai, Shanghai Municipality, China