RAD101 Shows Promising Tumor Uptake as Phase 2b Trial Reaches Halfway Point
Radiopharm Theranostics has reached the halfway mark in enrolling patients for its Phase 2b trial of RAD101, a novel imaging agent targeting brain metastases. Early data suggest RAD101 may outperform MRI in distinguishing tumor recurrence from radiation damage.
- 50% patient enrollment achieved in Phase 2b RAD101 trial
- Early data show significant tumor uptake compared to MRI
- RAD101 targets fatty acid synthase overexpressed in brain metastases
- Trial topline results expected in first half of 2026
- FDA Fast Track designation supports accelerated development
Halfway Milestone in Brain Metastases Imaging Trial
Radiopharm Theranostics, a clinical-stage biopharmaceutical company listed on the ASX and NASDAQ, announced it has reached 50% enrollment in its Phase 2b clinical trial evaluating RAD101, an innovative imaging agent designed to detect brain metastases. This milestone marks a significant step forward in the company’s efforts to improve diagnostic accuracy for patients with recurrent brain tumors.
RAD101 is a small molecule that targets fatty acid synthase (FASN), an enzyme overexpressed in many solid tumors including brain metastases. Early patient data from the trial, involving the first three participants, revealed significant and selective uptake of RAD101 in tumor tissue compared to conventional MRI scans. This suggests RAD101 could better distinguish between tumor recurrence and radiation necrosis, a common challenge in post-treatment brain imaging.
Clinical and Market Context
Brain metastases affect over 300,000 patients annually in the U.S. alone, with incidence rising partly due to improved systemic therapies that extend survival but increase the need for precise imaging follow-up. Currently, contrast-enhanced MRI is the standard imaging modality, but it has limitations in differentiating active tumor from treatment-related changes.
RAD101’s ability to target FASN offers a novel metabolic imaging approach that could enhance diagnostic confidence and guide treatment decisions. The Phase 2b trial is a multicenter, open-label study enrolling 30 patients with confirmed recurrent brain metastases from various solid tumors. The primary endpoint focuses on concordance between RAD101 PET imaging and MRI findings, while secondary endpoints assess diagnostic accuracy in distinguishing tumor recurrence from radiation effects.
Regulatory and Development Outlook
Importantly, RAD101 has received Fast Track designation from the U.S. Food and Drug Administration, underscoring its potential to address an unmet medical need. Positive results from a prior Phase 2a study conducted at Imperial College London demonstrated significant tumor uptake independent of tumor origin, further validating the approach.
With enrollment progressing steadily, Radiopharm Theranostics expects to complete the Phase 2b trial and report topline data in the first half of 2026. Should these results confirm RAD101’s clinical benefit, the company plans to initiate a global, multi-center Phase 3 registrational trial, potentially paving the way for regulatory approval and commercialisation.
As the company advances its pipeline of radiopharmaceuticals targeting solid tumors, RAD101’s progress highlights Radiopharm’s commitment to innovative oncology diagnostics that could transform patient care in brain metastases.
Bottom Line?
RAD101’s promising trial progress sets the stage for a pivotal Phase 3 study that could redefine brain metastases imaging.
Questions in the middle?
- Will RAD101’s Phase 2b data confirm superiority over MRI in larger patient cohorts?
- How quickly can Radiopharm initiate and complete a global Phase 3 trial following topline results?
- What impact will RAD101 have on clinical decision-making and patient outcomes if approved?
