RAD202 (177Lu-RAD202) - (HEAT)

Aug. 20, 2026: Radiopharm Theranostics (ASX: RAD, NASDAQ: RADX) said the Data Safety and Monitoring Committee recommended advancing 177Lu-RAD202 to the next dose level of 180 mCi in the Phase 1 HEAT trial in patients with HER2-positive advanced solid tumors. The recommendation followed DSMC review of study data and safety events, and the company said it supports the favorable safety profile seen so far.

RAD202 is a single-domain monoclonal antibody radiotherapeutic targeting HER2. The HEAT study is being conducted at clinical centers across Australia. The prior dose level in the trial was 130 mCi, which the company said was announced on April 8, 2026.

The release also noted prior clinical proof-of-concept from a diagnostic study in 10 HER2-positive breast cancer patients, where RAD202 showed positive safety and biodistribution.