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64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer (SECuRE) | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer (SECuRE)

A Phase I/IIa Theranostic Study of 64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer

NCT04868604•Clarity Pharmaceuticals Ltd

View on ClinicalTrials.gov

Summary

The aim of this study is to determine the safety and efficacy of 67Cu-SAR-bisPSMA in participants with PSMA-expressing metastatic castrate resistant prostate cancer.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Signed informed consent;
•≥18 years of age;
•Eastern Cooperative Oncology Group performance status of 0 to 2;
•Life expectancy \>6 months;
•Histological, pathological, and/or cytological confirmation of Prostate cancer (PCa);
•Positive 64Cu-SAR-bisPSMA PET/CT scan, where 64Cu-SAR-bisPSMA uptake (standardized uptake value \[SUV\] max) of at least 1 known lesion is higher than that of the liver on the 1 hour positron emission tomography (PET)/computed tomography (CT) scan;
•Castrate level of serum/plasma testosterone (\<50 ng/dL or \<1.7 nmol/L);
•Have progressive metastatic castration-resistant prostate cancer (mCRPC) despite prior androgen deprivation therapy and:
•* Dose Escalation: at least either enzalutamide and/or abiraterone (or other such androgen receptor pathway inhibitors \[androgen receptor pathway inhibitorsARPIs\]).
•* Cohort Expansion Main Group: Participant has progressed once or twice on a prior second generation ARPI (abiraterone, enzalutamide, darolutamide, or apalutamide). No concomitant ARPI on study. Note: First generation ARPI is allowed but not considered as prior ARPI. Second generation ARPI must be the most recent therapy received.
+18 more criteria

Exclusion Criteria

•Major surgery within 12 weeks prior to enrollment into the study;
•Brain metastasis;
•Histologic diagnosis of small cell or neuroendocrine prostate cancer;
•Prior history of leukemia or Myelodysplastic Syndrome;
•Diagnosis of Deep Vein Thrombosis or Pulmonary Embolism within 4 weeks prior to enrollment into the study;
•Unmanageable urinary tract obstruction;
•Evidence of progressive lesion(s) on MRI and/or CT (according to Response Evaluation Criteria in Solid Tumors V1.1) that is prostate-specific membrane antigen (PSMA) negative on the 1 hour 64Cu-SAR-bisPSMA PET/CT scan as determined at screening. NOTE: THIS CRITERION IS NOT APPLICABLE TO PARTICIPANTS IN THE 64Cu-SAR-bisPSMA DOSIMETRY PHASE AND DOSE ESCALATION PHASE.
•Previous treatment with a systemic radionuclide:
•* Dose Escalation: Previous treatment with a systemic radionuclide, including 177Lu, Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Actinium-225, Iodine-131 within 6 months or in case of Radium-223 within 3 months of treatment initiation (Day 0) without prior approval of the medical monitor;
•* Cohort Expansion: Previous treatment with a systemic radionuclide, including Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Iodine-131 within 6 months or in case of Radium-223 within 3 months of treatment initiation (Day 0) without prior approval of the medical monitor; Any previous PSMA targeted radionuclide therapy (including 177Lu and Actinium-225) is also excluded.
+16 more criteria

Locations (7)

Stanford Cancer Institute

Stanford, California, United States

East Jefferson General Hospital

River Ridge, Louisiana, United States

BAMF Health

Grand Rapids, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Washington University School of Medicine at Barnes-Jewish Hospital

St Louis, Missouri, United States

XCancer

Omaha, Nebraska, United States

Weill Cornell Medicine at New York-Presbyterian

New York, New York, United States

Key Dates

Start Date

August 11, 2021

Primary Completion Date

September 1, 2026

Completion Date

September 1, 2026

Last Updated

February 5, 2026

Enrollment

ESTIMATED participants

Conditions

Prostatic Neoplasms, Castration-Resistant

Interventions

64Cu-SAR-bisPSMA

DRUG

67Cu-SAR-bisPSMA

DRUG

Contacts

Clarity Pharmaceuticals

CONTACT

+61 (0) 2 9209 4037 clinicaltrials@claritypharmaceuticals.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: February 5, 2026Data 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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64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer (SECuRE)

Inclusion Criteria

Exclusion Criteria

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