On March 27, 2026 Radiopharm Theranostics (ASX:RAD, "Radiopharm" or the "Company"), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, reported that the first patient has been dosed in its first-in-human Phase 1 clinical trial of RAD 402, a monoclonal antibody targeting KLK3 radiolabelled with Terbium 161 being evaluated in advanced prostate cancer.
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The Phase 1 clinical trial (NCT07259213) is designed to study the safety, tolerability, whole-body distribution, and preliminary clinical activity of RAD 402 in patients with advanced prostate cancer. The dose escalation Phase 1 study is designed to determine the Maximum Tolerated Dose (MTD) and/or recommended phase 2 dose (RP2D) for expansion.
"Dosing the first patient in our Phase 1 study of RAD 402 marks an important step forward for Radiopharm and for patients with advanced prostate cancer," said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. "RAD 402 is a differentiated, first-in-class, next-generation radiotherapeutic designed to selectively target KLK3-expressing tumors while minimizing off-target exposure. With preclinical data demonstrating strong tumor uptake and minimal bone or marrow involvement, we are optimistic about its potential clinical profile. Advancing this program into the clinic reflects our continued commitment to delivering meaningful data across our portfolio this year. I like to take the opportunity to thank our partners, TerThera and Cyclotek, for the great support in supplying Tb161, radiolabelling, and distributing RAD 402."
About RAD 402
RAD 402 (NCT07259213) is an anti-KLK3 monoclonal antibody radiolabelled with the radionuclide 161Tb that is being evaluated in a Phase 1/2a clinical trial for the treatment of prostate cancer. Prostate Specific Antigen (PSA) is a widely used biomarker to detect prostate cancer and is encoded by the KLK3 gene. KLK3 is highly expressed in prostate cancer cells along with most adenocarcinomas of the prostate including their metastases and has limited expression in sites outside of the prostrate. Preclinical proof-of-concept biodistribution studies of RAD 402 in mouse xenografts showed strong tumor targeting, limited bone and marrow uptake, and a hepatic excretion profile consistent with expectations for a monoclonal antibody.
(Press release, Radiopharm Theranostics, MAR 27, 2026, View Source [SID1234663990])