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Highlights
- Radiopharm Theranostics has dosed the first patient in its Phase 1 ‘HEAT’ clinical trial of RAD202.
- The first-in-human study has been designed to evaluate the safety, tolerability, optimal dosing, and early efficacy signals of 177Lu-RAD202.
- The therapeutic potential of RAD202 has been validated through clinical and preclinical studies.
- The Phase 1 ‘HEAT’ trial is underway at multiple clinical sites across Australia.
Radiopharm Theranostics Limited (ASX:RAD), a clinical-stage radiotherapeutics company, has announced the dosing of the first patient in its Phase 1 ‘HEAT’ clinical trial of RAD202. This milestone marks a key step in RAD’s transition to a clinical-stage company.
RAD 202, a proprietary nanobody, targets Human Epidermal Growth Factor Receptor 2 (HER2)- positive expression in advanced solid tumours. The open-label ‘HEAT’ trial is a dose escalation study of 177Lu-RAD202, conducted at multiple sites across Australia.
Clinical Data Supports Advancement of RAD202
Previously, ten HER2-positive breast cancer patients were dosed in a Phase 1 diagnostic study of RAD202. The study showed clinical proof-of-concept, along with the safety and biodistribution of RAD202. These results highlight its potential to treat advanced HER2-expressing cancers. In addition, recent preclinical studies of 177Lu-RAD202 showed therapeutic effects in HER2-positive xenograft models. Together, these findings supported the launch of first-in-human dose-escalation studies, according to the company update.
Reflecting on the development, Radiopharm’s CEO and Managing Director, Riccardo Canevari, commented, “Despite progressive improvements in the management of metastatic HER2-positive disease, the majority of patients experience disease progression on current standard of care and require further therapeutic options. The dosing of the first patient in the ‘HEAT’ trial represents a significant step toward achieving RAD202’s potential to address an unmet need for HER2-positive metastatic patients who are progressing or unable to tolerate current treatment options. With RAD202, we hope to provide an option that can meaningfully improve clinical outcomes for HER2-positive patients, while preserving their quality of life.”
RAD shares were trading at AUD 0.026 at the time of writing on 04 June 2025.
