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

NCT04868604 | Recruiting Phase 1 FDA Drug

• 1 other identifier: CLP05
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Prostatic Neoplasms, Castration-Resistant

Outcome Measures

Primary Outcomes (12)

• Biodistribution of 64Cu-SAR-bisPSMA

  Biodistribution will be calculated by utilizing the PET/CT scans.

  48 hours

• Dosimetry of 64Cu-SAR-bisPSMA

  Dosimetry will be calculated by utilizing the PET/CT scans.

  48 hours

• Modelling of 67Cu-SAR-bisPSMA dosimetry utilizing the 64Cu-SAR-bisPSMA PET/CT scans

  Dosimetry will be calculated by utilizing the PET/CT scans.

  48 hours

• Maximum Tolerated Dose (MTD) or Maximum Feasible Dose of a single dose of 67Cu-SAR-bisPSMA

  MDT as determined by cohort observations of dose limiting toxicities (DLT)

  8 weeks

• Recommended dose of two doses of 67Cu-SAR-bisPSMA

  Recommended dose as determined by cohort observations of DLTs

  14 weeks

• Efficacy of 67Cu-SAR-bisPSMA in terms of Prostate specific Antigen (PSA) response

  Proportion of participants with ≥50% decline in PSA

  Up to 5 years

• Efficacy of 67Cu-SAR-bisPSMA in terms of radiographic response

  Efficacy will be assessed via the overall response rate according to RECIST V1.1 for soft tissue disease and according PCWG3 for bone lesions

  Up to 5 years

• Incidence of 67Cu-SAR-bisPSMA Treatment-Emergent Adverse Events [Safety and Tolerability]

  Adverse Events will be as assessed by CTCAE version 5.00

  Up to 5 years

• Safety and tolerability of 67Cu-SAR-bisPSMA: Number of Participants With Changes from baseline in Vital Signs

  Change from baseline in vital signs

  Up to 1 year

• Safety and tolerability of 67Cu-SAR-bisPSMA: Number of Participants With Changes from baseline in electrocardiogram (ECG) parameters

  Change from baseline in ECG parameters

  Up to 24 weeks

• Safety and tolerability of 67Cu-SAR-bisPSMA: Number of Participants With Changes from baseline in laboratory results

  Change from baseline in laboratory results

  Up to 22 weeks

• Incidence of 64Cu-SAR-bisPSMA Treatment-Emergent Adverse Events [Safety and Tolerability]

  Adverse Events will be as assessed by CTCAE version 5.00

  Up to 5 years

Study Arms (1)

67Cu-SAR-bisPSMA

EXPERIMENTAL

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 4 administrations of 67Cu-SAR-bisPSMA (dose will be determined based on cohort allocation). In the cohort expansion phase patients will receive up to 6 administrations of 67Cu-SAR-bisPSMA at the recommended dose level determined through dose escalation.

Drug: 64Cu-SAR-bisPSMA; Drug: 67Cu-SAR-bisPSMA

Interventions

64Cu-SAR-bisPSMA DRUG

64Cu-SAR-bisPSMA

67Cu-SAR-bisPSMA

67Cu-SAR-bisPSMA DRUG

67Cu-SAR-bisPSMA

67Cu-SAR-bisPSMA

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Cohort Expansion Concomitant Enzalutamide Group: Participant has progressed only once on prior second generation ARPI (prior abiraterone, darolutamide, or apalutamide is allowed, prior treatment with enzalutamide is not allowed). Note: First generation ARPI is allowed but not considered as prior ARPI. Second generation ARPI must be the most recent therapy received.
• 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.

You may not qualify if:

• 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.
• Previous treatment with any systemic anti-cancer therapy (e.g. immunotherapy or biological therapy \[including monoclonal antibodies\]) within 4 weeks prior to treatment on study with the exception of Luteinizing Hormone Releasing Hormone (LHRH), any other androgen deprivation therapy (ADT) or low dose corticosteroids.
• Dose Escalation: prior treatment with chemotherapy within 4 weeks of first administration of 67Cu-SAR-bisPSMA is also excluded.
• Cohort Expansion: Prior treatment with cytotoxic chemotherapy for castration resistant PCa (e.g. taxanes, platinum, estramustine, vincristine, methotrexate, etc) is also excluded. Note: Taxane exposure (maximum 6 cycles) in the adjuvant or neoadjuvant setting is allowed if 12 months have elapsed since completion of this adjuvant or neoadjuvant therapy. Prior treatment with any poly (adenosine diphosphate-ribose) polymerase inhibitors (PARPi) is also excluded. NOTE: THIS CRITERION IS NOT APPLICABLE TO PARTICIPANTS IN THE 64Cu-SAR-bisPSMA DOSIMETRY PHASE;
• Previous treatment with any investigational agents within 4 weeks prior enrollment into the study;
• Known hypersensitivity to the components of the investigational products or its analogues;

Sponsors & Collaborators

• Clarity Pharmaceuticals Ltd: lead

Study Sites (7)

Stanford Cancer Institute

Stanford, California, 94305, United States

RECRUITING

East Jefferson General Hospital

River Ridge, Louisiana, 70123, United States

RECRUITING

BAMF Health

Grand Rapids, Michigan, 49503, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Washington University School of Medicine at Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

RECRUITING

XCancer

Omaha, Nebraska, 68130, United States

RECRUITING

Weill Cornell Medicine at New York-Presbyterian

New York, New York, 10021, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms, Castration-Resistant

Condition Hierarchy (Ancestors)

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Clarity Pharmaceuticals

  Clarity Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Clarity Pharmaceuticals

CONTACT

+61 (0) 2 9209 4037; clinicaltrials@claritypharmaceuticals.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study is to be conducted in 3 phases, a dosimetry phase, a dose escalation phase and a cohort expansion phase.

Study Record Dates

• First Submitted: April 15, 2021
• First Posted: May 3, 2021
• Study Start: August 11, 2021
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Locations

US (7)