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.
Efficacy signals are encouraging: six participants had at least two post-treatment prostate-specific antigen (PSA) measurements, all showing declines.
Four participants achieved PSA reductions of ≥50% (PSA50), while two demonstrated reductions of ≥80% (PSA80).
One participant with bone metastases achieved undetectable PSA and no disease on imaging following three cycles, reporting excellent quality of life.
Clarity’s Executive Chair Dr Alan Taylor highlighted the potential of 67Cu-SAR-bisPSMA to advance prostate cancer treatment, noting ongoing planning for a registrational Phase 3 trial.
Recruitment for the Cohort expansion phase will continue through 2026, including a subset receiving combination therapy with enzalutamide.
At the time of reporting, Clarity Pharmaceuticals' share price was $3.36.