Purpose of this Study
We are doing this study to find the most safe and effective dose of an experimental drug called BMS-986460 (the study drug) for men with metastatic castration resistant prostate cancer.
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Are diagnosed with advanced or metastatic castration resistant prostate cancer
- Have already received a novel hormonal agent (such as abiraterone [Zytiga] or enzalutamide [Xtandi])
- Have not received platinum chemotherapy (previous taxane chemotherapy is okay)
Age Range
18-110
Sex/Genders
Male (cisgender)
Looking for Healthy Participants
No
What is Involved?
Description
The study is divided into three periods: a screening period, a study dosing period, and follow-up.
If you choose to join the study, you will go through a screening period that lasts about 2-4 weeks. During this period, you will:
- Have a cancer tissue biopsy
- Have a skin biopsy (from your shoulder)
- Have imaging done (CT and bone scan)
- Have blood draws and give urine samples
- Have physical exams
- Take the study drug by mouth once a day with breakfast
- Have clinic visits every week for 2 months, then every 2 weeks for 2 months, then once a month
- Have blood and urine tests, EKGs, physical exams, and CT and bone scans done at various visits throughout the study
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
A Phase 1, Open-label Study of BMS-986460 in Participants with Metastatic Castration-Resistant Prostate Cancer
Principal Investigator
Andrew
Armstrong
Protocol Number
PRO00114099
NCT ID
NCT06067841
Phase
I
Enrollment Status
Open to Enrollment