This is a Phase 1b, multi-center, open-label study to evaluate the safety, tolerability, dosimetry, and pharmacokinetics (PK) of \[64Cu\]Cu-AKY-2519 and/or \[225Ac\]Ac-AKY-2519, as well as the preliminary anti-tumor activity of \[225Ac\]Ac-AKY-2519 in participants with metastatic castration-resistant prostate cancer (mCRPC) with and without prior exposure to 177Lu-PSMA-617 (PLUVICTO™).
Age ≥ 18 years
Histologic or cytologic confirmation of prostatic adenocarcinoma
ECOG Performance Status of 0 or 1
Adequate end-organ function
Prior treatment with more than 2 Androgen receptor pathway inhibitors (ARPIs) and/or more than 1 taxane-based therapy in the mCRPC setting
Prior treatment with a targeted radiotherapy
Prior treatment with a B7-H3 targeted therapy
Received an investigational agent within the previous 28 days