Radiopharm Theranostics receives approval to start Phase 1 trial of RAD 202

Radiopharm Theranostic (RADX)s has been granted Belberry Human Research Ethics Committee approval in Australia to initiate its First-In-Human Phase 1 therapeutic clinical study of 177Lu-labelled RAD 202 for the treatment of HER2-expressing solid tumors. The open-label Phase 1 trial, entitled ‘HEAT’, is a dose escalation trial of 177Lu-RAD202, and is designed to evaluate the safety and preliminary clinical activity of this novel radiotherapeutic in individuals with HER2-expressing advanced cancers. RAD 202 is a single-domain monoclonal antibody that targets the Human Epidermal growth factor Receptor 2, which is overexpressed in breast cancer as well as several other solid tumors, and represents a validated target in oncology. The multicenter study is planned to recruit across Australia, with the support of leading oncology care provider GenesisCare CRO. Previous data1 demonstrated the safety and biodistribution of 99mTc-labeled RAD 202 in humans. Additional preclinical findings examining the therapeutic effect in HER2-positive xenografts were also recently reported with 177Lu-labeled RAD 2022. These data demonstrated tumor growth inhibition, significantly prolonged survival time, and further justify FIH dose finding studies.