Phase 1 trial shows safety and early PSA responses for novel PSMA radioligand in mCRPC

A Phase 1 study evaluated the long‑circulating PSMA therapeutic radioligand [177Lu]Lu‑D‑Dan‑Phe‑PSMA in patients with metastatic castration‑resistant prostate cancer. The trial enrolled several dose cohorts and monitored safety and tumor targeting.

Across all dose levels the agent was well tolerated, with no dose‑limiting toxicities observed during the 42‑day observation period. No immediate or life‑threatening serious adverse events were reported.

In the 3.70 GBq cohort, all three patients experienced a reduction in PSA after two treatment cycles, and two of the three achieved a decline of at least 50 % in PSA levels, indicating early signs of anti‑tumor activity.

These findings suggest that the radioligand delivers high tumor‑absorbed radiation doses while maintaining a manageable safety profile, supporting further clinical development.