Core Insights - The Data and Safety Monitoring Committee (DSMC) has approved the continuation of the Phase 1 clinical trial for 177Lu-RAD204 without modifications, allowing the company to proceed to the next dose level [1][2] - The company aims to complete enrollment of the first two cohorts by mid-2025, with an expansion to multiple tumor types beyond Non-Small Cell Lung Cancer (NSCLC) [2][3] Company Overview - Radiopharm Theranostics is a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for high unmet medical needs, listed on ASX (RAD) and NASDAQ (RADX) [6] - The company has a pipeline that includes one Phase 2 and three Phase 1 trials targeting various solid tumors, including lung, breast, and brain cancers [6] Clinical Trial Details - The first cohort of the Phase 1 study involved four patients treated with 30mCi of 177Lu-RAD204, showing positive safety and pharmacokinetic data, leading to the decision to increase the dose for the second cohort to 60mCi [2][4] - The second cohort will include patients with various PD-L1-driven cancers, such as SCLC, Triple-negative Breast Cancer (TNBC), Cutaneous Melanoma, head and neck squamous cell carcinoma (HNSCC), and Endometrial Cancer [2][4] Product Information - 177Lu-RAD204 is a single-domain monoclonal antibody targeting PD-L1, which is overexpressed in many solid tumors, making it a promising therapeutic target [4][5] - Previous Phase I imaging data indicated that the diagnostic compound is safe and associated with acceptable dosimetry [4]
Radiopharm Theranostics Accelerates 177Lu-RAD204 Phase 1 Dose Escalation Clinical Trial Based on Positive Recommendation from Data Safety and Monitoring Committee (DSMC)