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

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™).

Trial Details

NCT ID
NCT07581184
Phase
PHASE1
Sponsor
Aktis Oncology, Inc.
Status
RECRUITING
Cancer Type
Prostate Cancer
Interventions
  • [225Ac]Ac-AKY-2519 (therapeutic)
  • [64Cu]Cu-AKY-2519 (imaging)
Locations (sample)
  • Irvine, California, United States|33.66946,-117.82311
  • Miami, Florida, United States|25.77427,-80.19366
  • Kansas City, Kansas, United States|39.11417,-94.62746
  • Metairie, Louisiana, United States|29.98409,-90.15285
  • Boston, Massachusetts, United States|42.35843,-71.05977

Key Eligibility Criteria

  • Age ≥ 18 years
  • Histologic or cytologic confirmation of prostatic adenocarcinoma
  • ECOG Performance Status of 0 or 1
  • Adequate end-organ function

For full eligibility, visit ClinicalTrials.gov.

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