RV 01 (Betabart)

Aug. 26, 2026: Radiopharm Theranostics (ASX: RAD, NASDAQ: RADX) announced first-patient dosing in cohort 2 of its first-in-human Phase 1/2a trial of RV-01 (177Lu-Betabart) in patients with B7-H3-expressing tumors, after the independent Safety and Monitoring Committee recommended escalation to the 70 mCi dose.

RV-01 is a 177Lu-labeled engineered monoclonal antibody targeting the 4Ig isoform of B7-H3. The Phase 1/2a study (NCT07189871) is evaluating safety, biodistribution, pharmacokinetics, radiation dosimetry, and preliminary anti-tumor activity, with the goal of selecting a recommended dose for future studies. The U.S.-based trial aims to enroll 61 patients with confirmed castration-resistant prostate cancer, colorectal cancer, non-small cell lung cancer, small cell lung cancer, head and neck squamous cell cancer, ovarian cancer, cervical cancer, endometrial cancer, triple-negative breast cancer, or esophageal squamous cell carcinoma.

The company said initial clinical data are expected later in 2026.