Radiopharm Theranostics (ASX:RAD) announced a clinical milestone with the dosing of the first patient in its Phase 1 clinical trial of RAD 402.
The next-generation radiotherapeutic is being evaluated for the treatment of advanced prostate cancer, specifically targeting the KLK3 expression commonly found in prostate cancer cells and their metastases.
The study is designed as a dose-escalation trial to assess the safety, tolerability, and biodistribution of the drug, with the ultimate goal of identifying the maximum tolerated dose and the recommended dose for future Phase 2 expansion.
The innovative therapy leverages a monoclonal antibody radiolabelled with Terbium 161 (Tb161).
According to preclinical data derived from mouse xenografts, RAD 402 demonstrated exceptionally strong tumour targeting with minimal uptake in bone and marrow, suggesting a favourable safety profile and clear hepatic excretion.
CEO and Managing Director Riccardo Canevari emphasised that this first-in-human dosing represents a vital step toward delivering meaningful data for patients facing high unmet medical needs.
The company remains on track to share preliminary data from the first two dose levels in the second half of 2026.
The progress is supported by strategic partnerships with TerThera and Cyclotek, who assist in the supply and distribution of the radionuclide components.
By selectively targeting KLK3-expressing tumours while minimising off-target exposure, Radiopharm aims to establish RAD 402 as a differentiated, first-in-class treatment option within the rapidly evolving oncology landscape.