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68Ga-PSMA-0057 and 177Lu-PSMA-0057 in Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE1/PHASE2

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

NCT07310355•Chengdu StarRay Therapeutics Co., Ltd

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•1. Able to communicate well with investigators, understand the study purpose and requirements, voluntarily participate, and sign written informed consent.
•2. Male, ≥18 years at screening.
•3. Histologically or cytologically confirmed prostate cancer (excluding neuroendocrine prostate cancer and small cell prostate cancer), previously treated with at least one novel hormonal agent and 1-2 taxane-based regimens, or deemed intolerant to taxanes.
•4. Serum/plasma testosterone at castrate level (\<50 ng/dL or \<1.7 nmol/L).
•5. Documented progressive mCRPC based on ≥1 of the following: PSA progression (two consecutive PSA rises ≥1 week apart from a minimum value of 2.0 ng/mL); soft tissue progression per PCWG3 and RECIST v1.1; or bone progression with ≥2 new lesions.
•6. PSMA-positive on imaging with 68Ga-PSMA-0057 (within 3 days before treatment start) or other investigator-accepted PSMA tracers (within 6 months before treatment start), using criteria in Section 4.8.5.
•7. At least one measurable lesion per RECIST v1.1 and/or at least one bone metastasis per PCWG3.
•8. Estimated life expectancy ≥12 weeks.
•9. ECOG performance status 0-1 at baseline.
•10. Adequate organ and bone marrow function, meeting the following lab criteria:
+5 more criteria

Exclusion Criteria

•1. History of hypersensitivity to any study drug component or excipients, or history of specific allergic disease requiring systemic therapy, or other serious allergic reactions.
•2. Prior PSMA-targeted radioligand therapy, or treatment with radionuclides such as Sr-89, Sm-153, Re-186, Re-188, Ra-223, or hemibody radiation within 6 months prior to consent.
•3. Use of any investigational drug or device within 30 days before consent.
•4. Systemic anticancer therapy within 28 days or 5 half-lives prior to consent (whichever is longer), including chemotherapy, radiotherapy, immunotherapy, targeted therapy, systemic immunomodulatory drugs, or antitumor traditional Chinese medicines/formulations within 2 weeks before first dose.
•5. Another malignancy within the past 5 years, except for curatively treated cervical carcinoma in situ, non-melanoma skin cancers, etc.
•6. Major surgery or significant traumatic injury within 4 weeks before consent.
•7. Active brain metastases or CNS involvement, including untreated symptomatic lesions or those requiring radiation, surgery, or steroids within 1 month prior to screening.
•8. Symptomatic spinal cord compression or clinical/imaging findings suggestive of impending cord compression.
•9. Severe arterial/venous thromboembolic events within 6 months prior to screening; history of stroke; uncontrolled hypertension; decompensated heart failure (NYHA III-IV); LVEF \<50%; unstable angina; clinically significant arrhythmias requiring intervention.
•10. Significant acute or chronic infections, including active TB, systemic bacterial or fungal infections requiring systemic therapy.
+7 more criteria

Key Dates

Start Date

December 30, 2025

Primary Completion Date

June 30, 2028

Completion Date

April 30, 2030

Last Updated

December 30, 2025

Enrollment

ESTIMATED participants

Conditions

Metastatic Castration-resistant Prostate Cancer (mCRPC)

Interventions

68Ga-PSMA-0057

DRUG

177Lu-PSMA-0057

DRUG

Contacts

Project Manager, Chengdu StarRay Therapeutics Co., Ltd.

CONTACT

021-33987000 starraytx@fosunpharma.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 30, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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