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.
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:<ul>
<li>Are taking androgen deprivation therapy OR have had a bilateral orchiectomy</li>
<li>Have received at least one novel hormonal therapy (such as enzalutamide or abiraterone)</li>
<li>Have had 1 or more kinds of taxane-based chemotherapy (such as docetaxel)</li>
<li>Are taking androgen deprivation therapy OR have had a bilateral orchiectomy</li>
<li>Have received at least one novel hormonal therapy (such as enzalutamide or abiraterone)</li>
<li>Have had 1 or more kinds of taxane-based chemotherapy (such as docetaxel)</li>
Age Range
18-110
Sex/Genders
Male (cisgender)
Looking for Healthy Participants
No
What is Involved?
If you choose to join this study, you will:<ul>
<li>Receive a study drug called AMG-509 through a vein in your arm</li>
<li>Have blood, urine and saliva tests</li>
<li>Send a tumor biopsy to the sponsor</li>
<li>Have imaging tests (CT, MRI, and/or bone scan)</li>
<li>Complete questionnaires</li></ul>
You will have to stay in the hospital during and after your study drug infusions so we can monitor you for side effects. You may receive AMG-509 every week or every other week.
<li>Receive a study drug called AMG-509 through a vein in your arm</li>
<li>Have blood, urine and saliva tests</li>
<li>Send a tumor biopsy to the sponsor</li>
<li>Have imaging tests (CT, MRI, and/or bone scan)</li>
<li>Complete questionnaires</li></ul>
You will have to stay in the hospital during and after your study drug infusions so we can monitor you for side effects. You may receive AMG-509 every week or every other week.
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