Core Insights - Radiopharm Theranostics has received approval from the Bellberry Human Research Ethics Committee (HREC) in Australia to initiate a First-In-Human (FIH) Phase 1 clinical trial for RAD 402, a radiotherapeutic targeting KLK3 for metastatic or locally advanced prostate cancer [1][4] 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) [5] - The company has a diverse pipeline that includes one Phase 2 and four Phase 1 trials targeting various solid tumors, including lung, breast, and brain metastases [5] Product Details - RAD 402 is an anti-KLK3 monoclonal antibody radiolabelled with the radionuclide 161Tb, designed for the treatment of prostate cancer, with KLK3 being a key biomarker for the disease [2] - Preclinical studies have demonstrated strong tumor targeting and a favorable excretion profile for RAD 402, supporting its potential effectiveness [3] Clinical Development - The initiation of the Phase 1 trial for RAD 402 is significant as it is reportedly the first company-sponsored therapeutic trial utilizing 161Tb, highlighting the innovative approach of targeting KLK3 in advanced prostate cancer [4]
Radiopharm Theranostics Receives Approval to Initiate Phase 1 Therapeutic Trial of RAD 402 (KLK3-mAb with Tb161) in Advanced Prostate Cancer