Phase I/II Trial of 225Ac-PSMA-R2, PSMA-targeted alpha therapy.

This open-label study by Novartis evaluates the safety, tolerability, and anti-tumor activity of 225Ac-PSMA-R2—a PSMA-targeted alpha emitter—in men with metastatic castration-resistant and hormone-sensitive prostate cancer confirmed PSMA-positive. Subjects are enrolled in three cohorts based on prior 177Lu-PSMA radioligand therapy exposure, with dose escalation followed by expansion to identify the recommended dose.