Radiopharm Theranostics RAD101 Aligns with FDA for Phase 3 Brain Metastases Trial
Radiopharm Theranostics announced alignment with the U.S. FDA on the design of a pivotal Phase 3 trial for its oncology radiopharmaceutical, RAD101, intended for the diagnosis of brain metastases. The single, multicenter trial will enroll approximately 280 patients and focus on sensitivity and specificity as co-primary endpoints. RAD101 targets FASN, which is overexpressed in brain metastases, and has shown potential in Phase 2b trials to improve diagnostic accuracy compared to MRI. The company also confirmed a partnership with Siemens Healthineers for clinical supply and expects to initiate the trial in the first half of 2027.
Key Highlights
- Radiopharm Theranostics aligned with U.S. FDA on pivotal Phase 3 trial design for RAD101 in brain metastases.
- The Phase 3 trial will enroll approximately 280 patients with indeterminate brain metastases.
- Co-primary endpoints are sensitivity and specificity of RAD101 PET against a defined reference standard.
- RAD101 targets FASN, overexpressed in brain metastases, potentially improving detection accuracy.
- Phase 2b data showed 93% concordance between MRI and PET imaging, with PET identifying equivocal lesions on MRI.
- FDA Fast Track Designation received for RAD101 to distinguish recurrent disease from treatment effect.
- Partnership with Siemens Healthineers to supply 18F-labeled RAD101 for the Phase 3 trial.
- Company expects to complete CRO selection in Q4 2026 and initiate site activations in H1 2027.
Price Impact
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