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Highlights
- Radiopharm Theranostics’ Phase 2b trial of RAD101 for brain metastases imaging has reached 50% enrollment.
- Early patient data show significant and selective tumour uptake in brain metastases.
- Results from the Phase 2b trial are expected in the first half of 2026, with potential to lead to a Phase 3 international trial.
Radiopharm Theranostics (ASX:RAD) (NASDAQ:RADX), a clinical-stage biopharmaceutical company focused on oncology radiopharmaceuticals, has announced that its Phase 2b clinical trial of RAD101 has reached 50% enrollment. The trial is designed to evaluate RAD101's performance in imaging brain metastases.
Promising Early Data
Preliminary findings from the first three participants in the ongoing Phase 2b trial indicated substantial and selective tumour uptake in brain metastases. Brain metastases showed metabolic activity in imaging tests, which contrasted with the ambiguous results from MRI scans. These initial findings are in line with the earlier Phase 2a trial. If these results are verified, the next step will be to design a large-scale, international Phase 3 registrational trial.
Next Steps: Phase 2b Trial to Complete in 2026
The company expects to complete the full enrollment for the Phase 2b trial and release topline data in the first half of 2026.
RAD101: Targeting Fatty Acid Synthase for Precise Imaging
RAD101 is a novel small molecule that targets fatty acid synthase (FASN), an enzyme overexpressed in many solid tumours, including brain metastases. An imaging method targeting FASN activity could lead to better detection of cancer cells. A Phase 2a trial in patients with brain metastases at Imperial College London using the agent 18F-RAD101 found significant tumour uptake that was not affected by the tumour of origin. The study also offered initial evidence that PET-MRI might be able to non-invasively forecast how long a patient will survive, suggesting the need for larger studies.
Data source: Company update
Brain metastases are increasingly common; in the U.S. alone, more than 300,000 patients are diagnosed with cerebral metastases annually. However, current preferred imaging methods like contrast-enhanced MRI (CE-MRI) have limitations, particularly during follow-up surveillance scans intended to optimise patient care.
Details of the Phase 2 Clinical Trial
RAD Shares Rally
RAD shares were trading 4.55% higher at AUD 0.023 per share at the time of writing on 17 November 2025.
