Clinical Trial · NCT07581184

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

Overview

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

ClinicalTrials.gov

NCT07581184

Drug / Compound

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

Eligibility

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)