πŸ›οΈ Verified NIH Record β€’ Updated 2026-07-13

A Study of [225Ac]Ac-AKY-2519 in Patients With Metastatic Castration-Resistant Prostate Cancer (NCT07581184)

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

🟒 Recruiting Phase1 πŸ’Š Investigational Drug / Biologic Sponsor: Aktis Oncology, Inc.

🩺 Plain-English Summary (8th-Grade Level)

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 (PLUVICTOβ„’).

Who can join: Review the eligibility criteria below.

Location: Hoag Memorial Hospital Presbyterian β€” Irvine, California

Age range: 18 Years

πŸ“‹ "Do I Qualify?" β€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria β†—

πŸ“ All Participating Trial Locations (4 Sites)

  • Hoag Memorial Hospital Presbyterian β€” Irvine, California
  • Biogenix Molecular, LLC β€” Miami, Florida
  • BAMF Health β€” Grand Rapids, Michigan
  • XCancer β€” Omaha, Nebraska

πŸ“ž Contact the Study Coordinator

Phone: (857) 216-8482

Email: AKY-2519-01inquiries@aktisoncology.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

πŸ’° Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA Β§ 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Castration Resistant Metastatic Prostate Cancer

πŸ’‘ How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
πŸ›οΈ View Official NIH Record β†—