NCT07310355

68Ga-PSMA-0057 and 177Lu-PSMA-0057 in Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer

A Phase I/II, Single-Arm, Open-Label, Dose-Escalation and Expansion Study of 68Ga-PSMA-0057 and 177Lu-PSMA-0057 in Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 49 (estimated)
• Sponsor: Chengdu StarRay Therapeutics Co., Ltd · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, open-label, Phase I/II clinical study designed to evaluate the safety, tolerability, pharmacokinetics, dosimetry, pharmacodynamics, and preliminary efficacy of Gallium \[68Ga\] PSMA-0057 Injection and Lutetium \[177Lu\] PSMA-0057 Injection as an integrated theranostic regimen in patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC). The study consists of a Phase I dose-escalation phase to determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) of 177Lu-PSMA-0057, followed by a Phase II dose-expansion phase to further evaluate preliminary antitumor efficacy and confirm safety and pharmacologic profiles. Eligible participants will receive 68Ga-PSMA-0057 for PET imaging and 177Lu-PSMA-0057 for radioligand therapy. Key objectives include characterization of safety, tolerability, pharmacokinetics, dosimetry, pharmacodynamics, and preliminary therapeutic activity.

Conditions

• Metastatic Castration-resistant Prostate Cancer (mCRPC)

Interventions

Type	Name	Description
DRUG	68Ga-PSMA-0057	68Ga-PSMA-0057 IV administered as imaging agent for PET/CT.
DRUG	177Lu-PSMA-0057	177Lu-PSMA-0057 radiopharmaceutical solution for injection.

Timeline

• Start date: 2025-12-30
• Primary completion: 2028-06-30
• Completion: 2030-04-30
• First posted: 2025-12-30
• Last updated: 2025-12-30