On October 3, 2023 Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), a clinical stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, reported the dosing of the first patient in its theranostic 64Cu/67Cu SAR-Bombesin Phase I/II trial in metastatic castrate resistant prostate cancer (mCRPC) (Press release, Clarity Pharmaceuticals, OCT 3, 2023, View Source [SID1234635593]). 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.
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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."