drugset / Trial / NCT07581184
A Study of [225Ac]Ac-AKY-2519 in Patients With Metastatic Castration-Resistant Prostate Cancer
NaSingle-groupOpen-labelTreatment
Summary
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™).
Timeline
- Start
- 2026-07
- Primary completion
- 2027-12
- Completion
- 2032-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | [225Ac]Ac-AKY-2519 | Unknown | — | Intravenous |
| Subject | [64Cu]Cu-AKY-2519 | Diagnostic / imaging agent | — | Intravenous |