Radiopharm Theranostics (ASX:RAD) has achieved a milestone in its ongoing clinical development program for its radiotherapeutic asset, 177Lu-RAD204. The Data and Safety Monitoring Committee (DSMC) has approved it to proceed to the next dose in its Phase 1 clinical trial in patients with PD-L1-positive advanced cancers.
The DSMC is an independent multidisciplinary group that conducts detailed reviews of unblinded study data, discusses potential safety concerns and provides recommendations regarding trial continuation.
“We greatly appreciate the DSMC’s judicious review of our first cohort of patients in the Phase 1 study of Lu177-RAD204, which allows us to advance to the higher dose cohort in a variety of PD-L1- driven cancers,” said Riccardo Canevari, the CEO and managing director of Radiopharm Theranostics.
v“With this clearance from the DSMC, the increased number of active centres and expansion to multiple tumour types beyond Non-Small Cell Lung Cancer (NSCLC), we expect to accelerate our timelines for complete enrolment of the next cohort by mid-2025. We believe that RAD204 has the potential to strongly improve clinical outcomes for patients with PD-L1 positive advanced cancers and we look forward to seeing data from the first two cohorts of patients later this year.”
Radiopharm said the DSMC reviewed the first cohort of four patients treated with 30mCi of Lu177-RAD204 and confirmed positive safety, pharmacokinetic and biodistribution data. The DSMC agreed that the study may continue without modifications.
The second cohort of patients will start at 60mCi of Lu177 rather than 40mCi previously assumed in the protocol. The second cohort of patients is expected to be enrolled by mid-2025. It will include expansion to multiple tumor types including NSCLC, Small-Cell Lung Cancer, Triple-negative Breast Cancer, Cutaneous Melanoma, head and neck squamous cell carcinoma and Endometrial Cancer.
Radiopharm added that there are currently four clinical trial sites actively screening and recruiting patients in Australia.