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 Alan Taylor, commented, "SAR-Bombesin has already resulted in improvements to the management of prostate cancer for patients with PSMA-negative or low PSMA expressing lesions through diagnostic trials and we hope to confirm its safety and efficacy in this theranostic trial. We look forward to progressing the COMBAT trial and building on the compelling data from our preclinical and clinical studies to date. Combined with the logistical and manufacturing benefits of Targeted Copper Theranostics and with commercial quantities of the ⁶⁷Cu radioisotope now being routinely produced domestically in the US, we see a clear path to bringing SAR-Bombesin and SAR-bisPSMA to the prostate cancer patient population in need of novel treatments."