Clinical Trial

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

Study acronym: BActinium-1
Recruiting Phase 1
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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™).
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2026-05-06; most recent amendment 2026-07-13.
Trial Details
NCT Number NCT07581184
Lead Sponsor Aktis Oncology, Inc.
Conditions Castration Resistant Metastatic Prostate Cancer, Prostate Cancer, mCRPC (Metastatic Castration-resistant Prostate Cancer), mCRPC, B7H3
Enrollment 138 participants
Start Date 2026-07
Primary Completion 2027-12 (estimated)
Study Completion 2032-06 (estimated)
Updated on ClinicalTrials.gov 2026-07-14