Phase II trial of JSB462 (AR inhibitor) with 177Lu vipivotide tetraxetan (PSMA-directed beta emitter)

This Phase II trial, sponsored by Novartis Pharmaceuticals, evaluates the efficacy and safety of JSB462 in combination with lutetium vipivotide tetraxetan versus lutetium vipivotide tetraxetan alone in adult men with PSMA‐positive metastatic castration‐resistant prostate cancer. Participants have prior androgen receptor pathway inhibitor exposure and 0—2 taxane regimens. The study will assess two dosing arms for JSB462 and determine the optimal combination dose for phase III based on efficacy, safety, tolerability, and pharmacokinetic data.