Radiopharm Theranostics receives IND approval to initiate Phase 1 therapeutic trial of RAD 402 (KLK3-mAb with Tb161) in advanced prostate cancer

CAR-T Digest - August 2020

Weekly Digest - November 2025

18 November 2025: Radiopharm Theranostics receives IND approval to initiate Phase 1 therapeutic trial of RAD 402 (KLK3-mAb with Tb161) in advanced prostate cancer

Radiopharm Theranostics received Bellberry Human Research Ethics Committee (HREC) approval in Australia to begin its first-in-human Phase 1 trial of RAD 402, a KLK3-targeting radiotherapeutic for metastatic or locally advanced prostate cancer
RAD 402 is a humanized IgG1 monoclonal antibody that binds KLK3 (the gene encoding PSA) with high affinity and is radiolabeled with terbium-161 (Tb-161)
KLK3 is highly expressed in prostate tissue and in most prostate adenocarcinomas, making it a strong target for precision radiotherapy
Preclinical biodistribution studies in mouse xenografts showed strong tumor targeting, minimal bone and marrow uptake, and expected hepatic excretion, supporting its favorable safety and targeting profile
Tb-161’s dual emission of beta particles and Auger electrons underpins the antitumor activity of RAD 402, positioning it as a potential first-in-class therapeutic as it enters clinical evaluation supported by established radionuclide supply agreements