Radiopharm Theranostics (ASX:RAD), a clinical-stage biopharmaceutical company, has received approval from the Belberry Human Research Ethics Committee to commence its Phase 1 therapeutic trial in Australia.
The trial, named 'HEAT' (HER2 Antibody Therapy with Lutetium-177), will explore the safety and preliminary clinical activity of 177Lu-RAD202 in HER2-expressing advanced cancers, including breast and gastric cancers.
The Phase 1 first-in-human study aims to assess the response of individuals with HER2-positive metastatic solid tumours to the 177Lu-RAD202 treatment.
The therapy involves a single-domain monoclonal antibody that targets the Human Epidermal Growth Factor Receptor 2 (HER2), which is overexpressed in several cancer types, making it a significant target in oncology.
Previous studies involving 10 HER2-positive breast cancer patients have demonstrated the safety and promising distribution of 177Lu-RAD202, underpinning the potential for this new line of treatment.
The trial will be conducted across multiple centres in Australia, with GenesisCare CRO supporting the recruitment process.
"We are thrilled to receive approval to proceed with our Phase 1 FIH basket trial in Australia," said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics.
"RAD 202 has the potential to address an unmet treatment gap in HER2-positive metastatic patients that are refractory to or unable to tolerate current standard of care treatments," the executive added.
Radiopharm Theranostics has been listed on the ASX since November 2021 and continues to advance its pipeline of differentiated molecules targeting cancers, with ongoing trials across various stages of development.