Clarity Pharmaceuticals announced the dosing of the first patient in its theranostic (64) Cu® Cu SAR-Bombesin Phase I/II trial in metastatic castrate resistant prostate cancer . No issues were observed during the administration of 6GBq of (67) Cu 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 cancer (NCT05633160)(1) is a dose escalation and cohort expansion trial for up to 38 participants.

(64) Cu SAR- Bombesin is used to visualise gastrin-releasing peptide receptor (GRPr)-expressing lesions and select candidates for subsequent (67) Cu SAR-BBombesin therapy. The aim for the trial is to determine the safety and efficacy of (67) CuAR-Bombesin in participants with GRPr expressing mCRPC who are ineligible for therapy with (177) Lu PSMA-617. About SAR-Bombesin SAR-Bombesin is a highly targeted pan-cancer radiopharmaceutical with broad cancer application.

It targets the gastrin-releasingptide 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 leators, the SAR technology prevents copper leakage into the body. SAR-Bombesin is an Targeted Copper Theranostic (TCT) that can be used with isotopes of copper-64 (Cu-64 or (64) Cu) for imaging and copper-67 (Cu-67 or (67) Cu) for therapy. (64) Cu SAR the company and (67) Cu SAR-Bankesin 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 US Food and Drug Administration (FDA). A clinical development program is currently underway to assess the efficacy and safety of these products.

There is no guarantee that these products will become commercially available.