Radiopharm Theranostics (ASX:RAD) has been granted ethics approval in Australia to commence a Phase 1 First-In-Human (FIH) clinical trial of 177Lu-labeled RAD 202 for the treatment of HER2-expressing solid tumors.
The open-label, dose-escalation Phase 1 trial, known as 'HEAT' (HER2 Antibody Therapy with Lutetium-177), is designed to evaluate the safety, tolerability, and preliminary clinical activity of 177Lu-RAD202 in patients with HER2-expressing advanced cancers. The trial will be conducted across multiple centers in Australia, with support from GenesisCare CRO.
RAD 202: Targeting HER2 with Radiopharmaceutical Precision
RAD 202 is a single-domain monoclonal antibody (sdAb) that targets the Human Epidermal growth factor Receptor 2 (HER2), a validated oncology target overexpressed in breast cancer and other solid tumors. By labeling RAD 202 with Lutetium-177 (177Lu), Radiopharm aims to deliver targeted radiation directly to cancer cells, minimizing exposure to healthy tissue.
Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics, stated, "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. With RAD 202, we hope to provide an alternative strategy that can improve clinical outcomes for patients with HER2-positive advanced cancers, while potentially preserving their quality of life."
Clinical and Preclinical Evidence
Prior data demonstrated the safety and biodistribution of 99mTc-labeled RAD 202 in humans. Furthermore, preclinical studies evaluating the therapeutic effect of 177Lu-labeled RAD 202 in HER2-positive xenografts showed tumor growth inhibition and significantly prolonged survival time, providing a rationale for FIH dose-finding studies.
Trial Design and Patient Population
The 'HEAT' trial will enroll patients with HER2-expressing advanced cancers. As a dose escalation study, the trial will initially focus on assessing the safety and tolerability of 177Lu-RAD202. Secondary endpoints will include preliminary clinical activity. The study leverages the expertise of GenesisCare CRO to facilitate patient recruitment and trial execution across Australia.
