UPDATE: Phase 1 Trial for RAD 402 Dosed the First Patient

Following our previous article, we are pleased to report that patient dosing has commenced in this trial.

First patient has been dosed in this Phase 1 dose-escalation trial evaluating RAD 402, an anti-KLK3 (PSA) monoclonal antibody radiolabeled with Terbium-161 (Tb-161), in patients with advanced prostate cancer previously treated with standard therapies. Following our past article, we are happy to see that this trial has already started recruiting! This open-label study will assess safety, tolerability, biodistribution, dosimetry, pharmacokinetics, and preliminary antitumor activity across escalating dose levels to establish the maximum tolerated dose, with data from initial cohorts anticipated by late 2026.

RAD 402 leverages Tb-161’s unique emissions, beta particles for longer-range cytotoxicity and Auger electrons for localized DNA damage, to selectively target KLK3-expressing tumor cells, including metastases, while preclinical models indicate favorable tumor uptake, minimal bone marrow exposure, and predominant hepatic clearance.

Trial sites are active in Australia, with expansion planned based on early safety signals.

Clinical trial.