AMG 509 in patients with mCRPC (Prostate Cancer) - Clinical Trial

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
Adults

What is Involved?

If you choose to join this study you will:
- Receive a study drug called AMG-509 through an i.v.in 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
Protocol Number
IRB: PRO00105800
NCT: NCT04221542
Phase
Phase I
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Participate
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698