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Radiopharm aligns with FDA on single Phase 3 trial for RAD101 in brain metastases
RDPTFRadiopharm Theranostics Ltd
Radiopharm Theranostics reached alignment with the U.S. Food and Drug Administration (FDA) on the design of a pivotal, multicenter Phase 3 imaging trial for its investigational agent RAD101. The study will enroll approximately 280 patients with indeterminate brain metastases following radiotherapy to evaluate sensitivity and specificity against a reference standard. This single-trial approach is substantially smaller than historical registrational studies for similar agents. The company has partnered with Siemens Healthineers to manufacture clinical supply of the 18F-labeled tracer and expects to complete CRO selection in late 2026, initiating dosing in the first half of 2027. RAD101 targets fatty acid synthase (FASN) to improve detection of cancer cells in the central nervous system. Radiopharm Theranostics is a clinical-stage biopharmaceutical company developing innovative oncology radiopharmaceuticals for diagnostic and therapeutic applications.