Clinical Trial

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

Not Yet Recruiting Phase 1/2
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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.
Trial Details
NCT Number NCT07310355
Lead Sponsor Chengdu StarRay Therapeutics Co., Ltd
Conditions Metastatic Castration-resistant Prostate Cancer (mCRPC)
Enrollment 49 participants
Start Date 2025-12-30
Primary Completion 2028-06-30 (estimated)
Study Completion 2030-04-30 (estimated)
Updated on ClinicalTrials.gov 2025-12-30