Radiopharm Theranostics Advances RV-01 Trial with 70 mCi Dose in Solid Tumors
Radiopharm Theranostics has dosed the first patient in the second cohort of its Phase 1/2a trial for RV-01, a radiopharmaceutical targeting B7-H3 expressing solid tumors, marking a key dose escalation milestone.
- First patient dosed at 70 mCi RV-01 dose
- Phase 1/2a trial focuses on safety and anti-tumor activity
- RV-01 targets B7-H3 immune checkpoint in multiple cancers
- Joint venture with MD Anderson Cancer Center
- Initial clinical data expected later in 2026
Dose Escalation Milestone Reached in RV-01 Trial
Radiopharm Theranostics (ASX:RAD, Nasdaq: RADX) has dosed the first patient in the second cohort of its Phase 1/2a clinical trial for RV-01 (177Lu-Betabart), advancing to a 70 mCi dose following a positive safety recommendation from an independent Safety and Monitoring Committee. This step represents a significant clinical and operational milestone for the company’s first radiopharmaceutical therapeutic developed through its joint venture with MD Anderson Cancer Center.
Targeting B7-H3 Across Multiple Solid Tumors
RV-01 is a 177Lutetium-tagged engineered monoclonal antibody designed to bind with high affinity to the 4Ig isoform of B7-H3, an immune checkpoint molecule overexpressed in a variety of solid tumors. B7-H3 has gained attention as a promising target in oncology immunotherapy due to its broad tumor expression. Preclinical studies have demonstrated tumor shrinkage and prolonged survival in animal models treated with RV-01, supporting its potential as a differentiated therapeutic approach.
Trial Design and Objectives
The ongoing Phase 1/2a trial is a dose escalation and expansion study enrolling patients with B7-H3 expressing tumors, including prostate, colorectal, lung, head and neck, ovarian, cervical, endometrial, triple negative breast, and esophageal cancers. Its goals are to evaluate safety, biodistribution, radiation dosimetry, and preliminary anti-tumor activity to establish the recommended dose for future development. The trial is being conducted across multiple clinical centres in the United States.
Company Leadership Highlights Progress
CEO Riccardo Canevari described the dosing of the first patient in the 70 mCi cohort as a key indicator of the program’s progression through dose escalation, reinforcing confidence in RV-01’s development pathway. Chief Medical Officer Dimitris Voliotis emphasised the compelling nature of B7-H3 as a target and the potential for RV-01 to address significant unmet needs in oncology. The company is focused on enrolling patients in this cohort and anticipates reporting initial clinical data later this year.
Positioning Within Radiopharm’s Pipeline
RV-01 is the inaugural therapeutic radiopharmaceutical from Radiopharm Ventures, the joint venture between Radiopharm and MD Anderson Cancer Center. It complements Radiopharm’s broader clinical program, which includes multiple Phase 1 and Phase 2 trials across various solid tumor indications. This development follows recent progress in other Radiopharm candidates, underscoring the company’s commitment to advancing innovative radiopharmaceuticals in oncology.
Bottom Line?
The successful dose escalation to 70 mCi in the RV-01 trial sets the stage for critical clinical readouts later in 2026, which will be pivotal in validating this novel approach to targeting B7-H3 in solid tumors.
Questions in the middle?
- Will RV-01 demonstrate meaningful clinical efficacy in diverse B7-H3 expressing tumors?
- How will safety and tolerability evolve at higher dose levels in the ongoing trial?
- What regulatory pathways will Radiopharm pursue following Phase 1/2a data readouts?
