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Highlights
- The DSMC has recommended advancing RAD202 to a 130mCi dose level in the Phase 1 HEAT trial.
- Radiopharm progresses from Cohort 2 to Cohort 3 in its HER2-positive solid tumour stud.
- Radiopharm expects to complete Phase 1 dose escalation by the end of 2026.
- RAD202 targets HER2, a well-established oncology biomarker in multiple solid tumours.
Radiopharm Theranostics (ASX:RAD) has received a recommendation from the Data Safety and Monitoring Committee (DSMC) to proceed to the next dose level of its clinical-stage radiotherapeutic candidate, 177Lu-RAD202, in the Phase 1 ‘HEAT’ clinical trial involving patients with Human Epidermal Growth Factor Receptor 2 (HER2)-positive advanced solid tumours.
Dose Escalation Approved in Phase 1 Trial
The DSMC has recommended advancing RAD202 to a dose level of 130mCi in the Phase 1 ‘HEAT’ study. The committee, composed of multidisciplinary experts, undertakes comprehensive reviews of trial data and evaluates safety events before providing recommendations on trial continuation. The study is currently underway across multiple clinical sites in Australia.
Trial Progress and Timeline
The company has reported continued progress in the Phase 1 ‘HEAT” trial, moving dose escalation from Cohort 2 to Cohort 3. Radiopharm Theranostics has indicated that it remains on schedule to complete Phase 1 dose escalation by the end of 2026. A prior update in October 2025 documented advancement to the 75mCi dose level.
About RAD202 and HER2 Targeting
RAD202 is a proprietary single-domain monoclonal antibody designed to target HER2 expression in advanced solid tumours. HER2 is commonly overexpressed in breast cancer and other multiple solid tumours, making it a recognized target in oncology research. Earlier diagnostic studies involving HER2-positive breast cancer patients demonstrated proof-of-concept along with observed safety and biodistribution outcomes.
The DSMC recommendation marks the next step in the clinical evaluation of RAD202, as Radiopharm Theranostics continues its Phase 1 trial in HER2-positive advanced solid tumours. The study remains in progress, with further updates anticipated as dose escalation advances.
RAD shares were trading at AUD 0.021, up 5%, at the time of writing on 8 April 2026.
