BMS CA125-1008: AR degradation in mCRPC patients

What is the 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.

What is the Condition Being Studied?

Metastatic Castration Resistant Prostate Cancer

Who Can Participate in the Study?

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)

For more information about this study, please contact the study team at blayne.carney@duke.edu.

What is Involved?

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

If we find that you are eligible to continue, you will proceed to the study dosing period. During this period of the study, you will:

  • 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

You will take the study drug until your study doctor believes it is no longer necessary or giving you any benefit. When you stop taking the study drug, you will enter the follow-up portion of the study. During this portion, you will visit our clinic monthly for PSA checks and every 3 months for imaging.

Study Details

Full Title
A Phase 1, Open-label Study of BMS-986460 in Participants with Metastatic Castration-Resistant Prostate Cancer
Principal Investigator
Professor of Medicine
Protocol Number
IRB: PRO00114099
NCT: NCT06067841
Phase
Phase I
ClinicalTrials.gov
Enrollment Status
OPEN TO ACCRUAL
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