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SEC filingRadiopharm Theranostics received DSMC positive recommendation to advance 177Lu-RAD202 Phase 1 HEAT trial to Cohort 3 at 130mCi dose level in HER2+ advanced solid tumor patients.
Radiopharm Theranostics announced a key milestone in its lead radiotherapeutic asset, 177Lu-RAD202, with the Data Safety and Monitoring Committee (DSMC) providing a positive recommendation to escalate dosing to 130mCi in Cohort 3 of the Phase 1 HEAT trial. This progression from the prior 75mCi dose level in Cohort 2 highlights the asset's favorable safety profile, enabling accelerated development in HER2-positive advanced solid tumors, a validated oncology target overexpressed in breast and other cancers. CEO Riccardo Canevari emphasized the rapid trial execution, reinforcing confidence in completing dose escalation by year-end 2026. RAD202, a proprietary single-domain antibody radioconjugate, builds on prior diagnostic study data showing clinical proof-of-concept, positive safety, and biodistribution in ten HER2-positive breast cancer patients. For investors, this de-risks the program, supports pipeline momentum across five Phase 1 and one Phase 2 trials targeting lung, breast, prostate, and brain cancers, and positions Radiopharm to address high unmet needs in radiotherapeutics.