Core Insights - The company has received a positive recommendation from the Data Safety and Monitoring Committee (DSMC) to advance its clinical-stage radiotherapeutic asset, 177Lu-RAD202 (RAD202), to the next dose level of 75mCi in the Phase 1 'HEAT' clinical trial for patients with HER2-positive advanced solid tumors [1][2]. Group 1: Clinical Trial Progress - The Phase 1 'HEAT' trial is progressing rapidly, with initial dosing starting in June and the first cohort completed swiftly [2]. - The DSMC confirmed positive safety, pharmacokinetic, and biodistribution data from the first cohort treated with 30mCi of Lu177-RAD202, allowing the study to continue without modifications [2]. - The second cohort of patients is expected to be enrolled by Q4 2025 [2]. Group 2: Product Information - RAD202 is a proprietary single domain monoclonal antibody targeting HER2-positive expression in advanced solid tumors, which are prevalent in breast cancer and other solid tumors [4]. - Previous diagnostic studies have shown RAD202's clinical proof-of-concept, along with positive safety and biodistribution results [4]. Group 3: Company Overview - Radiopharm Theranostics is a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for high unmet medical needs [5]. - The company is listed on ASX (RAD) and NASDAQ (RADX) and has a pipeline that includes one Phase 2 and three Phase 1 trials across various solid tumor cancers [5].
Radiopharm Theranostics Receives Positive Recommendation from Data Safety and Monitoring Committee (DSMC) to Accelerate 177Lu-RAD202 Phase 1 ‘HEAT’ Dose Escalation Clinical Trial