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].

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]