Actively Recruiting
A Phase I/IIa Study of 64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer
Led by Clarity Pharmaceuticals Ltd · Updated on 2026-05-06
54
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of two drugs, 64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA, in men with prostate cancer that has spread and no longer responds to hormone-lowering treatments. This study focuses on cancers that express a protein called PSMA and aims to find safe and effective dosing while monitoring how the drugs behave in the body. Participants will go through different study phases. In the initial dosimetry phase, a single dose of 200 MBq of 64Cu-SAR-bisPSMA is given. Later phases involve receiving multiple doses of 64Cu-SAR-bisPSMA or 67Cu-SAR-bisPSMA, with doses and number of administrations varying by phase and participant group. The dose escalation phase tests increasing doses of 67Cu-SAR-bisPSMA, followed by a cohort expansion phase with up to six doses of the recommended 67Cu-SAR-bisPSMA dose. During the study, participants will undergo PET/CT scans to track drug distribution and dosimetry within 48 hours of dosing. Researchers will measure prostate-specific antigen (PSA) levels and radiographic responses over up to five years to evaluate treatment effects. Safety will be monitored through assessments of vital signs, ECGs, laboratory tests, and recording any adverse events. The total study duration can extend up to five years for long-term follow-up.
CONDITIONS
Brief Title
64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer (SECuRE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Male participants aged 18 years or older
- Eastern Cooperative Oncology Group performance status of 0 to 2
- Life expectancy greater than 6 months
- Confirmed diagnosis of prostate cancer
- Positive 64Cu-SAR-bisPSMA PET/CT scan with uptake higher than liver in at least one lesion
- Castrate levels of serum/plasma testosterone (<50 ng/dL or <1.7 nmol/L)
- Progressive metastatic castration-resistant prostate cancer despite prior androgen deprivation therapy
- Prior treatment with enzalutamide and/or abiraterone or other androgen receptor pathway inhibitors as specified
- At least one metastatic lesion visible on recent imaging
- Recovery to Grade 2 or less from prior treatment toxicities
- Adequate organ function including bone marrow, liver, and kidney criteria
- For HIV-positive participants: must be healthy with low risk of AIDS outcomes
- Use of effective birth control for participants or their partners of childbearing potential
You will not qualify if you...
- Major surgery within 12 weeks before study enrollment
- Presence of brain metastases
- Diagnosis of small cell or neuroendocrine prostate cancer
- History of leukemia or myelodysplastic syndrome
- Recent deep vein thrombosis or pulmonary embolism within 4 weeks
- Unmanageable urinary tract obstruction
- PSMA-negative progressive lesions on PET/CT scan (except in certain study phases)
- Prior systemic radionuclide therapy within specified timeframes without approval
- Recent systemic anti-cancer therapy or chemotherapy within defined periods
- Previous treatment with investigational agents within 4 weeks
- Known hypersensitivity to study drugs or their components
- Transfusion given only to meet eligibility
- Spinal metastasis with symptomatic or impending cord compression
- Serious concurrent medical conditions impairing participation
- Other malignancies expected to affect life expectancy or study assessments
- Conditions posing unacceptable radiation safety risks
- Planned external beam radiation therapy after enrollment (except in certain phases)
- Specific exclusions for participants in the concomitant enzalutamide group including hypersensitivity, seizure history, loss of consciousness, and conditions increasing seizure risk
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 14 weeks
Participants receive up to 3 administrations of 64Cu-SAR-bisPSMA and up to 6 administrations of 67Cu-SAR-bisPSMA depending on the study phase and cohort assignment.
Up to 9 treatment visits depending on phase and cohort
Duration - Up to 5 years
Participants are monitored for safety, treatment response, and adverse events following treatment with 67Cu-SAR-bisPSMA.
Periodic visits for safety and efficacy assessments
Trial Site Locations
Total: 7 locations
1
Stanford Cancer Institute
Stanford, California, United States, 94305
Actively Recruiting
2
East Jefferson General Hospital
River Ridge, Louisiana, United States, 70123
Actively Recruiting
3
BAMF Health
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
4
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
5
Washington University School of Medicine at Barnes-Jewish Hospital
St Louis, Missouri, United States, 63110
Actively Recruiting
6
XCancer
Omaha, Nebraska, United States, 68130
Actively Recruiting
7
Weill Cornell Medicine at New York-Presbyterian
New York, New York, United States, 10021
Actively Recruiting
Research Team
C
Clarity Pharmaceuticals
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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