Radiopharm Theranostics (ASX:RAD) has entered a significant new phase in its oncology program, announcing that the first patient has been dosed in a First-In-Human Phase 1/2a clinical trial of its experimental radiotherapeutic candidate, 177Lu BetaBart, also known as RV-01.
The development marks the first time a therapy created through Radiopharm Ventures, the company’s joint venture with The University of Texas MD Anderson Cancer Center, has advanced into human clinical testing.
The study is designed to evaluate safety, biodistribution and radiation dosimetry while also gathering early signals of anti-tumour activity. Researchers will use the trial to determine the recommended dose for future studies, positioning the program for later-stage development if results prove encouraging. The therapy previously received Investigational New Drug clearance from the United States Food and Drug Administration in mid 2025, allowing the trial to proceed.
177Lu BetaBart is an engineered monoclonal antibody linked to the radioisotope Lutetium 177. It targets the 4Ig isoform of B7-H3, an immune checkpoint molecule highly expressed across multiple aggressive cancers and increasingly recognised as a promising immunotherapy target. By delivering radiation directly to tumour cells expressing this marker, the therapy aims to combine the specificity of antibody targeting with the cell-killing power of radiotherapy.
Preclinical studies in animals have already shown tumour shrinkage and extended survival, supporting the rationale for testing the agent in humans. Investigators believe the approach may ultimately be applicable across a broad range of difficult-to-treat malignancies, including prostate, pancreatic and breast cancers, as well as other solid tumours.
Radiopharm’s leadership described the first dosing as an important inflection point for the company and its pipeline. The trial is expected to enrol 61 participants with advanced cancers spanning multiple tumour types, including castration resistant prostate cancer, colorectal cancer, lung cancers, ovarian and cervical cancers, triple-negative breast cancer and several other solid tumours.