Radiopharm Theranostics said its Data Safety and Monitoring Committee has cleared the company to advance its RAD202 radiotherapeutic to a higher dose level in a Phase 1 clinical trial.
The HEAT study, evaluating 177Lu-RAD202 in patients with HER2-positive advanced solid tumors, received approval to escalate from 130mCi to 180mCi. The previous dose level was announced on April 8, 2026, following a review of safety and efficacy data.
The Phase 1 trial is part of a broader clinical program that includes one Phase 2 study and five Phase 1 studies targeting solid tumors such as lung, breast, prostate, and brain cancers. The company did not disclose enrollment numbers or specific safety outcomes from prior dose levels.
RAD202 is a single-domain monoclonal antibody designed to target HER2-positive expression in advanced solid tumors, a biomarker overexpressed in breast cancer and other malignancies. A prior diagnostic study involving ten HER2-positive breast cancer patients showed clinical proof-of-concept with positive safety and biodistribution results, according to the company.
The trial is being conducted at clinical centers in Australia. Radiopharm Theranostics, listed on the ASX under ticker RAD and on the NASDAQ under RADX, did not provide additional details on timing for patient enrollment or next milestones.
