Clarity advances dose escalation for cohort in SECuRE trial

2021 01 16 00 14 5464 Prostate Cancer 400

Radiopharmaceutical developer Clarity Pharmaceuticals is highlighting the completion of the second cohort, as well as the advancement to the third cohort in the dose escalation phase of its phase I/II theranostic trial, SECuRE.

The trial is evaluating the performance of copper-64 (Cu-64)/copper-67 (Cu-67) SAR-bisPSMA in patients with metastatic castration-resistant prostate cancer (mCRPC). The trial is a multicenter, single-arm, dose-escalation trial with a cohort expansion involving up to 44 patients in the US. The goal is to determine the safety and efficacy of Cu-67 SAR-bisPSMA for the treatment of prostate cancer.

The second cohort of the dose escalation, where three participants received a single administration of 8 GBq of Cu-67 SAR-bisPSMA, has been completed. Clarity said no dose-limiting tissues have been reported in any of the patients dosed to date and that the trial's progression to the third cohort will see a dose increase to 12 GBq.

Clarity also said the third cohort will be the last to assess single doses of Cu-67 SAR-bisPSMA and will be followed by a multi-dose cohort, pending safety evaluation. All three participants in the second cohort remain on the trial and are showing a prostate-specific antigen reduction, with two of the three showing an initial reduction of around 90%. The company said that a decline of 50% or greater is one of the primary endpoints of the trial.

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