No issues were observed during the administration of 6GBq of 67Cu SAR-Bombesin and the participant continues to be followed for further safety and efficacy assessments as per protocol.
COMBAT, which derives from 'Copper-67 SAR Bombesin in metastatic castrate resistant prostate cancer' (NCT05633160)1 is a dose escalation and cohort expansion trial for up to 38 participants. 64Cu SAR-Bombesin is used to visualise gastrin-releasing peptide receptor (GRPr)-expressing lesions and select candidates for subsequent 67Cu SAR-Bombesin therapy. The aim for the trial is to determine the safety and efficacy of 67Cu SAR-Bombesin in participants with GRPr expressing mCRPC who are ineligible for therapy with 177Lu PSMA-617. These patients are unlikely to benefit from prostate-specific membrane antigen (PSMA)-targeted agents and represent a significant unmet need for both imaging and therapy. Doses of up to 14GBq of 67Cu SAR-Bombesin, in up to four cycles, are planned to be investigated in this trial (pending safety reviews).
Clarity's Executive Chairperson, Dr
About SAR-Bombesin
SAR-Bombesin is a highly targeted pan-cancer radiopharmaceutical with broad cancer application. It targets the gastrin-releasing peptide receptor (GRPr) present on cells of a range of cancers, including but not limited to prostate, breast and ovarian cancers. GRPr is found in up to 100% of prostate cancers, including prostate cancers that don't express PSMA (PSMA-negative)2-6. The product utilises Clarity's proprietary sarcophagine (SAR) technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-Bombesin is a Targeted Copper Theranostic (TCT) that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy.
64Cu SAR-Bombesin and 67Cu SAR-Bombesin are unregistered products. Individual results may not represent the overall safety and efficacy of the products. The data outlined in this announcement has not been assessed by health authorities such as the
About Prostate Cancer
Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death worldwide7.
Approximately 25% of mCRPC patients have low or no uptake of a PSMA-targeting tracer.9 These patients are therefore unlikely to respond to therapeutic PSMA-targeted products and currently have few treatment options available to them. Given the prostate cancer indication is one of the largest in oncology, there is a significant unmet medical need in this segment. The SAR-Bombesin product could offer valuable imaging and therapeutic options for not only PSMA-negative patients, but also the large number of patients that have the target receptor on their cancers.
About Clarity
Clarity is a clinical stage radiopharmaceutical company focused on the treatment of serious disease. The Company is a leader in innovative radiopharmaceuticals, developing targeted copper theranostics based on its SAR Technology Platform for the treatment of cancer in children and adults.
Contact:
Dr
Tel: +61 (0)413 871 165
Email: ataylor@claritypharm.com
Web: www.claritypharmaceuticals.com
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