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
Clarity Pharmaceuticals Ltd
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 range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
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 m…
Interventions
- Drug64Cu-SAR-bisPSMA
64Cu-SAR-bisPSMA
- Drug67Cu-SAR-bisPSMA
67Cu-SAR-bisPSMA
Locations (7)
- Stanford Cancer InstituteStanford, California
- East Jefferson General HospitalRiver Ridge, Louisiana
- BAMF HealthGrand Rapids, Michigan
- Mayo ClinicRochester, Minnesota
- Washington University School of Medicine at Barnes-Jewish HospitalSt Louis, Missouri
- XCancerOmaha, Nebraska