Radiopharm Theranostics (ASX:RAD) has commenced the first-in-human Phase 1/2a clinical trial of its novel radiopharmaceutical, 177Lu-Betabart (RV-01).
The company confirmed that the first patient has been dosed, marking a critical transition from preclinical success to clinical evaluation for the treatment of aggressive solid tumours.
Developed through Radiopharm Ventures—a collaborative joint venture with The University of Texas MD Anderson Cancer Centre—RV-01 is an engineered monoclonal antibody tagged with Lutetium-177.
The therapy specifically targets the B7-H3 immune checkpoint, a protein frequently overexpressed in various high-risk cancers.
Because deregulated B7-H3 expression is often linked to increased tumour aggressiveness and poor patient outcomes, it has become a primary focus for next-generation immunotherapy.
The dose-escalation study intends to enrol 61 participants across a broad spectrum of histopathologically-confirmed cancers, including triple-negative breast, prostate, lung, and esophageal squamous cell carcinomas.
Researchers will scrutinise the drug's safety profile, biodistribution, and anti-tumour activity to establish an optimal dose for future pivotal studies.
CEO Riccardo Canevari hailed the commencement as a "highly differentiated" step forward, noting that preclinical models demonstrated significant tumour shrinkage and prolonged survival.
With FDA investigational new drug clearance already secured, Radiopharm aims to validate RV-01 as a versatile weapon against some of the most challenging malignancies in modern oncology.
At the time of reporting, Radiopharm Theranostics' share price was $0.022.