Australian Company Finalizes Phase III Protocol for Brain Metastasis Imaging Radiopharmaceutical

Recently, Radiopharm Theranostics announced that it has received the final meeting minutes from the FDA End-of-Phase 2 meeting, during which both parties reached agreement on the design of the pivotal Phase III imaging trial for RAD101, advancing registration development preparations for this investigational radiopharmaceutical imaging agent.

The study is planned as a single-arm, multicenter Phase III trial designed to enroll approximately 280 patients with previously irradiated brain metastases of indeterminate nature. The co-primary endpoints are the sensitivity and specificity of RAD101 PET relative to an established reference standard.

RAD101 is labeled with Fluorine-18, and its development goal is to help identify brain metastasis lesions and improve the differentiation between tumor recurrence and treatment-related changes. Siemens Healthineers will provide drug manufacturing and distribution support for the planned U.S. Phase III trial.

The company expects to proceed with site initiation after completing clinical research organization selection, and to begin patient dosing in a subsequent phase. This progress pertains to trial protocol and regulatory pathway communications and does not represent drug approval or marketing authorization, nor does it indicate that the Phase III trial has been completed or has confirmed diagnostic efficacy.