RecruitingPhase 1NCT07581184

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

BActinium-1: A Phase 1b, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Intravenous Administration of B7-H3 Radiopharmaceutical ([225Ac]Ac-AKY-2519) in Metastatic Castration-Resistant Prostate Cancer

Sponsor

Aktis Oncology, Inc.

Enrollment

138 participants

Start Date

Jul 1, 2026

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer mCRPC (Metastatic Castration-resistant Prostate Cancer)Castration Resistant Metastatic Prostate Cancer mCRPC B7H3

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™).

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called [225Ac]Ac-AKY-2519 (therapeutic) and a drug called [64Cu]Cu-AKY-2519 (imaging) for people with b7h3, castration resistant metastatic prostate cancer, and other related conditions. The study is currently recruiting participants at 3 locations. People eligible for this study include men aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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