Clarity Hits SECuRE Cohort Expansion Main Group Target

Clarity (ASX:CU6) Pharmaceuticals has reached the recruitment target for the Main Group of the Cohort Expansion in its Phase I/IIa SECuRE trial of 67Cu-SAR-bisPSMA, while recruitment continues for the arm combining the treatment with enzalutamide.

Sixteen participants with metastatic castration-resistant prostate cancer (mCRPC) are enrolled in the Main Group and are being evaluated on up to six cycles of 8 GBq of 67Cu-SAR-bisPSMA. The Cohort Expansion aims to assess 24 mCRPC patients before taxane or radioligand-based therapies, with or without enzalutamide (approximately 8 and 16 participants, respectively). The release restates data from 19 participants reported on 5 August 2026: after a median of 2 cycles (range: 1-4) at 8 GBq, 74% of evaluable participants achieved PSA25, 63% PSA50, 53% PSA75 and 26% PSA90. Among 16 radiographically evaluable participants at 8 GBq, 81% achieved disease control, 50% with stable disease and 31% with complete response or undetectable disease. Seven participants across the program have achieved complete response/undetectable disease. The company says most related adverse events were mild or moderate and transient, and that it is planning a registrational theranostic Phase III trial.

The efficacy figures restate data reported on 5 August 2026; updates on the most recently enrolled participants are expected in the coming months. 67Cu-SAR-bisPSMA is unregistered and has not been assessed by health authorities such as the FDA or TGA.