Radiopharm Theranostics (ASX:RAD), a developer of oncology radiopharmaceuticals, has reached a clinical milestone following a positive recommendation from the Data Safety and Monitoring Committee.
The company is now authorised to progress its Phase 1 'HEAT' clinical trial of 177Lu-RAD202 to the next dose level of 130mCi.
The transition to Cohort 3 marks a crucial step in evaluating the safety and efficacy of the radiotherapeutic asset in patients battling HER2-positive advanced solid tumours.
The DSMC’s endorsement follows a rigorous review of safety data from the previous 75mCi dose level, which was initiated in October 2025.
By confirming a favourable safety profile, the committee has allowed the company to accelerate its dose-escalation schedule.
CEO and Managing Director Riccardo Canevari expressed optimism regarding the trial's momentum, noting that the company remains on track to complete the Phase 1 dose escalation by the conclusion of 2026.
RAD202 is a proprietary single-domain monoclonal antibody designed to precisely target HER2, a protein frequently overexpressed in breast cancer and various other solid tumours.
Initial diagnostic studies involving HER2-positive breast cancer patients have already demonstrated successful proof-of-concept, showcasing promising biodistribution and safety.
At the time of reporting, Radiopharm Theranostics’ share price was $0.020.