RecruitingPhase 1NCT07660211

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

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)


Sponsor

VitsGen Therapeutics Inc.

Enrollment

10 participants

Start Date

Jun 16, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called 177Lu-PSMA-VG01 for people with psma-positive metastatic castration-resistant prostate cancer (mcrpc). The study is currently recruiting participants at 1 location. People eligible for this study include men aged 18 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG177Lu-PSMA-VG01

Treatment patients


Locations(1)

Zhong Shan Hospital Fudan University

Shanghai, Shanghai Municipality, China

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NCT07660211