drugset / Trial / NCT07581184

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

NCT07581184 ↗

Phase 1 Recruiting 138 enrolled Aktis Oncology, Inc.
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

EvaluationDrugModalityDoseRoute
Subject [225Ac]Ac-AKY-2519 Unknown — Intravenous
Subject [64Cu]Cu-AKY-2519 Diagnostic / imaging agent — Intravenous