Clarity Pharmaceuticals (ASX:CU6) has announced that the SECuRE trial, a Phase 1/2a study of 67Cu-SAR-bisPSMA for metastatic castration-resistant prostate cancer, will continue with no modifications to its protocol following a safety review committee meeting.
The interim review assessed nine participants with evaluable data as of Nov. 25, the majority of whom had received at least two cycles of 8 GBq of 67Cu-SAR-bisPSMA.
Two participants received combination therapy with enzalutamide. Most participants were heavily pre-treated, with over half having undergone more than five prior anti-cancer regimens, and two-thirds presented with bone metastases.
The safety profile remains favorable, with most adverse events being Grade 1 or 2, predominantly nausea and lymphopenia, and no overall renal or ECG abnormalities reported.