MedTrace Logo

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

NCT07581184 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2026-05-12

No results posted yet for this study

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™).

Conditions

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

Interventions

DRUG

[225Ac]Ac-AKY-2519 (therapeutic)

\[225Ac\]Ac-AKY-2519 Injection

DRUG

[64Cu]Cu-AKY-2519 (imaging)

\[64Cu\]Cu-AKY-2519 Injection

Sponsors & Collaborators

  • Aktis Oncology, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2027-12-31
Completion
2032-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07581184 on ClinicalTrials.gov