Radiopharm’s BetaBart Trial Begins Amid High Hopes and Clinical Risks
Radiopharm Theranostics has initiated dosing in its Phase 1/2a clinical trial of BetaBart, a novel radiotherapeutic developed with MD Anderson Cancer Center, targeting aggressive solid tumors.
- First patient dosed in Phase 1/2a trial of 177Lu-BetaBart (RV-01)
- BetaBart developed by Radiopharm Ventures joint venture with MD Anderson Cancer Center
- Trial to assess safety, biodistribution, radiation dosimetry, and preliminary anti-tumor activity
- Preclinical studies showed tumour shrinkage and prolonged survival in animal models
- Targeting B7-H3 immune checkpoint molecule overexpressed in multiple solid tumours
A Milestone in Radiopharmaceutical Oncology
Radiopharm Theranostics has reached a significant milestone with the dosing of the first patient in its Phase 1/2a clinical trial for 177Lu-BetaBart (RV-01), marking the first clinical use of a radiotherapeutic agent developed through its joint venture with the MD Anderson Cancer Center. This trial represents a crucial step in translating promising preclinical results into potential new treatment options for patients with advanced solid tumours.
Innovative Targeting of B7-H3
BetaBart is a radiolabelled monoclonal antibody engineered to target the 4Ig isoform of B7-H3, an immune checkpoint molecule that is notably overexpressed in various aggressive cancers including prostate, pancreatic, breast, and lung tumours. By delivering targeted radiation directly to cancer cells, BetaBart aims to shrink tumours while sparing healthy tissue, a strategy that could offer a differentiated approach compared to existing therapies.
Trial Design and Objectives
The Phase 1/2a trial is designed as a dose escalation and expansion study to evaluate the safety profile, biodistribution, radiation dosimetry, and preliminary anti-tumour activity of BetaBart. It will also establish the recommended dose for future studies. The trial plans to enrol 61 participants with a range of advanced solid tumours, including castrate-resistant prostate cancer, colorectal cancer, various lung cancers, and triple-negative breast cancer, reflecting the broad potential application of this therapy.
Collaborative Strength and Clinical Expertise
The development of BetaBart through Radiopharm Ventures, a partnership between Radiopharm Theranostics and the MD Anderson Cancer Center, leverages world-class scientific expertise and clinical infrastructure. The involvement of BAMF Health, a leading centre for radiopharmaceutical trials, underscores the commitment to delivering high-quality care and rigorous evaluation of this novel agent.
Looking Ahead
While still early in clinical development, BetaBart’s promising preclinical data showing tumour shrinkage and prolonged survival in animal models provide a hopeful outlook. The coming months will be critical as safety and initial efficacy data emerge, potentially positioning BetaBart as a new weapon in the fight against difficult-to-treat solid tumours.
Bottom Line?
BetaBart’s first patient dosing sets the stage for a potentially transformative radiotherapeutic in oncology.
Questions in the middle?
- How will BetaBart’s safety and efficacy profile compare to existing radiotherapeutics targeting solid tumours?
- What timeline can investors expect for initial clinical data readouts from this Phase 1/2a trial?
- Could BetaBart’s targeting of B7-H3 open opportunities in combination therapies or other cancer indications?
