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

Who is this study for? Patients with Castration-Resistant Prostate Cancer
What treatments are being studied? 64Cu-SAR-bisPSMA+67Cu-SAR-bisPSMA
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2

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.

Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: No

• 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 at least either enzalutamide and/or abiraterone (or other such androgen receptor pathway inhibitors). Documented progressive mCRPC will be based on at least 1 of the following criteria:

• Serum/plasma prostate specific antigen (PSA) progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimal value for study enrollment is 2.0 ng/mL;

• Soft-tissue progression defined as a ≥20% increase in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since the last treatment directed at the metastatic cancer has started (not including hormonal therapy) or the appearance of 1 or more new lesions;

• Progression of bone disease: evaluable disease or new bone lesions(s) by bone scan.

• ≥1 metastatic lesion that is present at screening CT, magnetic resonance imaging (MRI), or bone scan imaging obtained ≤28 days prior to enrollment into the study;

• Participants must have recovered to ≤ Grade 2 from all clinically significant toxicities related to prior therapies (prior chemotherapy, radiation, immunotherapy, etc.);

• Participants must have adequate organ function:

• Bone marrow reserve:

• White blood cell (WBC) count ≥2.5 x 109/L (2.5 x 109/L is equivalent to 2.5 x 103/μL and 2.5 x K/μL and 2.5 x 103/cc and 2500/μL) OR

• Absolute neutrophil count (ANC) ≥1.5 x 109 /L (1.5 x 109 /L is equivalent to 1.5 x 103 /μL and 1.5 x K/μL and 1.5 x 103 /cc and 1500/μL);

• Platelets ≥100 x 109 /L (100 x 109 /L is equivalent to 100 x 103 /μL and 100 x K/μL and 100 x 103 /cc and 100,000/μL);

• Hemoglobin ≥9 g/dL (5.59 mmol/L);

• Total bilirubin ≤1.5 x the institutional upper limit of normal (ULN). For participants with known Gilbert's Syndrome ≤3 x ULN is permitted;

• Alanine aminotransferase or aspartate aminotransferase ≤3.0 x ULN OR ≤5.0 x ULN for participants with liver metastases;

• Creatinine clearance or estimated glomerular filtration rate ≥50 mL/min

• For participants who are human immunodeficiency virus infected: Participant must be healthy and have a low risk of Acquired Immune Deficiency Syndrome related outcomes in the opinion of the Investigator;

• For participants who have partners of childbearing potential: Partner and/or participant must use a method of birth control with adequate barrier protection.

United States
Mayo Clinic
Not yet recruiting
Tulane Cancer Center, Tulane Medical School
Not yet recruiting
New Orleans
Johns Hopkins
Not yet recruiting
Mayo Clinic
Washington University School of Medicine at Barnes-Jewish Hospital
Saint Louis
GU Research Network
New York
Weill Cornell Medicine at New York-Presbyterian
Not yet recruiting
New York
Contact Information
Clarity Pharmaceuticals
+61 (0) 2 9209 4037
Time Frame
Start Date: August 11, 2021
Estimated Completion Date: September 2026
Target number of participants: 44
Experimental: 67Cu-SAR-bisPSMA
In the dosimetry phase patients will receive a single 200 MBq administration of 64Cu-SAR-bisPSMA.~In the dose escalation phase patients will receive up to 2 administrations of 200 MBq of 64Cu-SAR-bisPSMA.~In the cohort expansion phase patients will receive up to 3 administrations of 200 MBq of 64Cu-SAR-bisPSMA.~In the dose escalation phase patients will receive up to 2 administrations of 67Cu-SAR-bisPSMA (dose will be determined based on cohort allocation).~In the cohort expansion phase patients will receive 2 administrations of 67Cu-SAR-bisPSMA at the recommended dose level determined through dose escalation.
Geoffrey Johnson, Scott Tagawa, Alan Bryce, Martin Pomper, Luke Nordquist, Lilja Solnes, Amir Iravani, Oliver Sartor
Related Therapeutic Areas
Leads: Clarity Pharmaceuticals Ltd

This content was sourced from clinicaltrials.gov