SAR-BBN Radiotracers for Prostate Cancer
(COMBAT Trial)
Trial Summary
What is the purpose of this trial?
The aim for this study is to determine the safety and efficacy of 67Cu-SAR-BBN in participants with Gastrin Releasing Peptide Receptor (GRPR)-expressing metastatic castrate resistant prostate cancer in patients who are ineligible for therapy with 177Lu-PSMA-617.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, certain treatments like systemic anti-cancer therapy must be stopped at least 4 weeks before starting the trial, except for specific hormone therapies and low-dose corticosteroids.
What data supports the effectiveness of the treatment 64Cu-SAR-BBN for prostate cancer?
Research shows that copper-64 (64Cu) is effective in imaging and potentially treating prostate cancer due to its ability to target specific receptors on cancer cells. In a study, a similar treatment using copper-67 (67Cu) significantly inhibited tumor growth in mice, suggesting that copper-based treatments like 64Cu-SAR-BBN could be promising for prostate cancer.12345
Is 64Cu-SAR-BBN safe for use in humans?
What makes the SAR-BBN radiotracers unique for prostate cancer treatment?
The SAR-BBN radiotracers, using copper isotopes like 64Cu and 67Cu, are unique because they target the gastrin-releasing peptide receptor (GRPR) which is overexpressed in prostate cancer cells, allowing for both precise imaging and targeted therapy. This dual capability, known as theranostics, enables the same compound to be used for both diagnosing and treating cancer, which is not common in many existing treatments.23456
Research Team
Clarity Pharmaceuticals
Principal Investigator
Clarity Pharmaceuticals
Eligibility Criteria
This trial is for adults with metastatic castrate resistant prostate cancer that expresses GRPR, who can't have 177Lu-PSMA-617 therapy. They must have good kidney function, progressive bone disease visible on scans, and a positive PET/CT scan with 64Cu-SAR-BBN. Participants need to be ineligible for certain other treatments and recovered from previous therapies' side effects.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive up to 2 administrations of 64Cu-SAR-BBN and single or multiple administrations of 67Cu-SAR-BBN based on cohort allocation
Cohort Expansion
Participants receive up to 3 administrations of 64Cu-SAR-BBN and 2 administrations of 67Cu-SAR-BBN at the recommended dose level
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- 64Cu-SAR-BBN
- 67Cu-SAR-BBN
Find a Clinic Near You
Who Is Running the Clinical Trial?
Clarity Pharmaceuticals Ltd
Lead Sponsor