Phase 1b Study of Intravenous 225AcAc-AKY-2519 for Treating Metastatic Castration-Resistant Prostate Cancer in Men

What this Trial Is About

Researchers are evaluating the safety, tolerability, dosimetry, pharmacokinetics, and preliminary anti-tumor activity of the radiopharmaceutical 225AcAc-AKY-2519 in people with metastatic castration-resistant prostate cancer mCRPC. This Phase 1b, multi-center, open-label study includes participants with and without prior exposure to 177Lu-PSMA-617 PLUVICTO17. The purpose is to assess these aspects and gather early information to guide further development. The study has two parts a dose escalation portion and a backfill portion. Dose escalation involves two parallel cohortsCohort A includes participants without prior 177Lu-PSMA-617 exposure, and Cohort B includes those with such exposure. The backfill phase will focus on selected dose levels from each cohort to collect additional safety and efficacy data and to determine recommended Phase 2 doses. Participants receive intravenous administration of 225AcAc-AKY-2519 and may also receive 64CuCu-AKY-2519 for imaging. Participants will be monitored for adverse events and dose-limiting toxicities during treatment cycles of 28 days. Safety assessments continue up to 30 days after the last dose. Researchers will evaluate tumor response, progression-free survival, and prostate-specific antigen PSA responses, with some outcomes measured up to five years after treatment. Neurological stability and organ function are assessed, and participants must comply with study requirements throughout the trial.

A Study of [225Ac]Ac-AKY-2519 in Patients With Metastatic Castration-Resistant Prostate Cancer