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.
Who Can Participate?
Eligibility
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 Range
18-110
Sex/Genders
Male (cisgender)
Looking for Healthy Participants
No
What is Involved?
Description
If you choose to join this study, you will:
- Receive a study drug called AMG-509 through a vein in your arm
- Have blood, urine and saliva tests
- Send a tumor biopsy to the sponsor
- Have imaging tests (CT, MRI, and/or bone scan)
- Complete questionnaires
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
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
Andrew
Armstrong
Protocol Number
PRO00105800
NCT ID
NCT04221542
Phase
I
Enrollment Status
Open to Enrollment