Radiopharm says DSMC says Phase 1 study may continue as planned

Radiopharm (RADX) achieved a key milestone in its ongoing clinical development program for its clinical-stage radiotherapeutic asset, 177Lu-RAD204, as the Data and Safety Monitoring Committee has approved 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. The DSMC reviewed the first cohort of four patients treated with 30mCi of 177Lu-RAD204 and confirmed that there was positive safety, pharmacokinetic and biodistribution data and 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-year 2025 and 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. There are currently four clinical trial sites actively screening and recruiting patients in Australia.