AMG 509 in patients with mCRPC (Prostate Cancer)

What is the Purpose of this Study?

We are doing this study to learn if a new study drug called AMG-509 is safe and effective in men who have metastatic, castrate-resistant prostate cancer. AMG-509 is a type of drug that helps a type of immune cells called T cells find and kill prostate cancer cells.

The first part of this study will test different doses of AMG-509 in men, to learn what side effects the study drug causes and which doses are safe. The second part of the study will see if a safe dose of AMG-509 slows cancer growth.

This study will also teach us how long AMG-509 stays in your body, and whether treatment with AMG-509 changes the genes and proteins found in your tumor cells.

What is the Condition Being Studied?

Metastatic Castrate-Resistant Prostate Cancer

Who Can Participate in the Study?

Adults with metastatic castrate-resistant prostate cancer who:

  • Are taking androgen deprivation therapy OR have had a bilateral orchiectomy
  • Have received at least one novel hormonal therapy (such as enzalutamide or abiraterone)
  • Have had 1 or more kinds of taxane-based chemotherapy (such as docetaxel)
Age Group

What is Involved?

If you choose to join this study you will:

  • Receive a study drug called AMG-509 through an a vein in your arm
    • You will have to stay in the hospital during and after your i.v. infusion, so we can monitor you for side effects
    • You may receive AMG-509 every week or every other week
  • Have blood, urine and saliva tests
  • Send a tumor biopsy to the sponsor
  • Have imaging tests (CT, MRI, and/or bone scan)
  • Complete questionnaires

Study Details

Full Title
A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 509 in Subjects With Metastatic Castration-Resistant Prostate Cancer
Principal Investigator
Professor of Medicine
Protocol Number
IRB: PRO00105800
NCT: NCT04221542
Phase I
Enrollment Status