Radiopharm Theranostics (ASX:RAD) Begins Phase 2b U.S. Trial for 18F-RAD101

Clinical Trial Initiation

Radiopharm Theranostics has dosed the first patient in its Phase 2b imaging study of 18F-RAD101 for suspected recurrent brain metastasis in the U.S. The multicenter, open-label, single-arm trial aims to evaluate the diagnostic performance of the novel imaging agent in 30 individuals with confirmed recurrent brain metastases from various solid tumours.

Study Objectives

The primary objective is to assess the concordance between 18F-RAD101 positive lesions and those identified through conventional MRI with gadolinium. RAD101 targets fatty acid synthase (FASN), overexpressed in many solid tumours, enabling accurate cancer cell detection.

Executive Comments

Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics, stated, “18F-RAD101 has the strong potential to improve diagnostic accuracy of brain metastases, and holds promise for discriminating between treatment effect and true progression in the more than 300,000 patients diagnosed with brain metastasis each year in the U.S. alone. We look forward to advancing this clinical trial and to reporting topline data in the second half of 2025.”

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