Clarity’s theranostic prostate cancer trial advances to highest dose level

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Clinical stage radiopharmaceutical company Clarity Pharmaceuticals (ASX:CU6) has announced the completion of cohort two and advancement to cohort three in the dose escalation phase of its Phase 1/2 theranostic trial, SECuRE.

The trial is evaluating the company's 64Cu/67Cu SAR-bisPSMA in patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC).

In the trial, 64Cu SAR-bisPSMA is used to visualise PSMA-expressing lesions and select candidates for subsequent 67Cu SAR-bisPSMA therapy.

The trial is a multi-centre, single-arm, dose-escalation trial with a cohort expansion involving up to 44 patients in the US. The aim of the trial is to determine the safety and efficacy of 67Cu SAR-bisPSMA for the treatment of prostate cancer.

The second cohort two of the dose escalation, where three participants received a single administration of 8GBq of 67Cu SARbisPSMA, has been completed. The company said no dose-limiting toxicities have been reported in any of the patients dosed to date.

The third cohort will be the last to assess single doses of 67Cu SAR-bisPSMA and will be followed by a multi-dose cohort, pending safety evaluation.