Radiopharm receives DSMC recommendation to advance Phase 1 ‘HEAT’ trial

Radiopharm (RADX) Theranostics announced that it has received a positive recommendation from the Data Safety and Monitoring Committee to advance its clinical-stage radiotherapeutic asset, 177Lu-RAD202, to the next dose level of 75mCi in the Phase 1 ‘HEAT’ clinical trial in patients with Human Epidermal Growth Factor Receptor 2-positive advanced solid tumors. The DSMC is a multidisciplinary committee that conducts detailed reviews of study data, discusses potential safety events and provides recommendations regarding trial continuation. The DSMC reviewed the first cohort of patients treated with 30mCi of Lu177-RAD202 and confirmed there was positive safety, pharmacokinetic, and biodistribution data and agreed that the study may continue without modifications and accelerate to the second cohort of patients at 75mCi of Lu177-RAD202. The second cohort of patients is expected to be enrolled by Q4 2025. The Phase 1 ‘HEAT’ study is currently being conducted at clinical centers across Australia.