XCancer

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

Description:

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™).

Sponsor:

Unknown Organization

Phase:

Phase 1

Contacts:

Tiffany Wang, MD (CONTACT)

aky-2519-01inquiries@aktisoncology.com

+1-857-216-8482

Government Study Link:

NCT07581184 - Click here to see study on

ClinicalTrials.gov

AKY-2519

Isotope(s):
Target(s):
  • B7H3
Ligand Class: Small Proteins and Antibody Fragments

AKY-2519

Isotope(s):
Target(s):
  • B7H3
Ligand Class: Small Proteins and Antibody Fragments

PSMA-617

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Chelator: DOTA
Inclusion
  • Adequate end-organ function
  • Histologic or cytologic confirmation of prostatic adenocarcinoma
  • Patients with CNS metastases are eligible if they have received therapy and are neurologically stable, asymptomatic and not receiving corticosteroids
  • Documented disease progression on most recent prior line of therapy, either by PSA or imaging-based progression
Exclusion
  • Prior treatment with a B7-H3 targeted therapy
  • Prior treatment with more than 2 Androgen receptor pathway inhibitors (ARPIs) and/or more than 1 taxane-based therapy in the mCRPC setting
  • Prior treatment with a targeted radiotherapy o Exception: Cohort B is required to have had at least 2 prior doses of 177Lu-PSMA-617 (PLUVICTO)