Radiopharm Theranostics (ASX:RAD) has announced the dosing of the first patient in its US Phase 2b imaging study of 18F-RAD101 in suspected recurrent brain metastasis.
The multicentre, open-label, single-arm Phase 2b clinical trial¹ is evaluating the diagnostic performance of 18f-RAD101 in 30 people with confirmed recurrent brain metastases from solid tumours of different origins.
Radiopharm said the study's primary objective is to determine the concordance between 18f-RAD101-positive lesions and those seen in conventional imaging (MRI with gadolinium) in participants with suspected recurrent brain metastases.
RAD101 is a novel imaging small molecule that targets fatty acid synthase (FASN). This multi-enzyme protein catalyses fatty acid synthesis and is overexpressed in many solid tumours, including cerebral metastasis. Disruption of FASN activity allows for the accurate detection of cancer cells, representing a strong viable target for the imaging of brain metastasis.
The company said positive data from the Imperial College of London’s Phase 2a imaging trial of 18f-RAD101 in patients with brain metastases showed significant tumour uptake consistent with and independent from the tumour of origin.
“We are proud to pioneer the first U.S. clinical trial of RAD101,” said Dr Harshad R. Kulkarni, chief medical advisor at BAMF Health and principal investigator of this Phase 2b study. “This marks an important step toward improving diagnostic precision and enabling more evidence-based, individualised treatment decisions for patients with brain metastases following stereotactic radiosurgery.”
“This trial is an excellent illustration of BAMF Health’s clinical trials platform in action,” added BAMF Health’s director of clinical trials. “Our Radiopharmacy is producing the imaging agent on-site, our clinic team is caring for the patient and providing the best image in the world, and our clinical trials team expertly coordinates it all. BAMF’s facility and team were built to do trials just like this.”
“Current standard of care imaging is less sensitive in discriminating between tumour recurrence and radiation necrosis in patients with brain metastasis who have received anticancer treatments, including radiation,” said Riccardo Canevari, the CEO and managing director of Radiopharm Theranostics. “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.”
