CU6.ASX: First patient treated in the Phase II of the SECuRE trial

First patient treated in the Phase II of the SECuRE trial

Stock	Clarity Pharmaceuticals Ltd (CU6.ASX)
Release Time	15 Apr 2025, 9:40 a.m.
Price Sensitive	Yes

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Clarity treats first patient in Phase II of SECuRE trial

Key Points

First patient dosed with 8 GBq of 67Cu-SAR-bisPSMA in Cohort Expansion Phase
Combination therapy with enzalutamide added to trial protocol
Improved 67Cu-SAR-bisPSMA formulation with room temperature stability rolled out

Full Summary

Clarity Pharmaceuticals has announced the treatment of the first participant with 8 GBq of 67Cu-SAR-bisPSMA in the Cohort Expansion Phase (Phase II) of the SECuRE trial. This follows the successful completion of the Dose Escalation Phase (Phase I) and the recommendation by the Safety Review Committee to progress to the Cohort Expansion Phase at the 8 GBq dose level, with an increase in the total number of cycles from up to 4 to up to 6. The participant will be receiving the combination of 8 GBq of 67Cu-SAR-bisPSMA and enzalutamide (ARPI), allowed by a recent protocol amendment. This amendment increased the number of participants in this cohort from 14 to 24, with a subset receiving the combination therapy. These changes are aligned with the positive results from the Enza-p trial and ongoing discussions with key global medical experts.In preparation for the Cohort Expansion Phase, Clarity has rolled out an improved 67Cu-SAR-bisPSMA product formulation. The enhanced formulation offers room temperature stability, supply and scalability, which are essential for late-stage clinical trials and streamlined commercial-scale manufacture.