Radiopharm Theranostics (ASX:RAD) has announced that the final patient has been dosed in its US Phase 2b imaging trial for RAD 101.
The trial, spanning multiple centres across the US, is evaluating the performance of RAD 101 in patients with confirmed recurrent brain metastases from a range of solid tumours. The company said early indications have been promising, with interim data showing a 90 per cent concordance rate with MRI scans, the study’s primary benchmark.
Riccardo Canevari, CEO and Managing Director, said, “Dosing the final patient in our most advanced diagnostic program represents an important milestone for Radiopharm and underscores the continued momentum of our radiopharmaceutical pipeline.”
Canevari cited the interim findings as a source of confidence, noting that the strong alignment with MRI results reinforces RAD 101's potential to improve diagnostic accuracy. “The interim results we have seen to date, demonstrating a high level of concordance with MRI, reinforce our confidence in RAD 101’s potential to address a critical unmet need in the accurate detection of recurrent brain metastases,” he said.
With the full dataset expected mid-year, Radiopharm plans to move swiftly into a US Phase 3 pivotal trial while engaging regulators to determine the most effective approval pathway. Canevari emphasised the broader clinical implications, saying, “We believe RAD 101 has the potential to meaningfully improve clinical decision-making for patients and physicians navigating this challenging disease.”
Canevari also acknowledged the human effort behind the trial’s progress. “I would like to take the opportunity to thank all the patients, families, and caregivers for their trust in our clinical trial. The investigators and the Clinical Center did an amazing job in the recruitment process, and our congratulations go to BAMF HEALTH for leading the table of the top recruiters,” he said.