BMS-986460 for Prostate Cancer

Recruiting at 6 trial locations

Overseen By First line of the email MUST contain the NCT# and Site#

Age: 18+

Sex: Male

Trial Phase: Phase 1

Sponsor: Bristol-Myers Squibb

Must be taking: Androgen deprivation

Disqualifiers: Brain metastases, Cardiac disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8-12 weeks

90 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called BMS-986460 to see if it is safe and effective for men with advanced prostate cancer that doesn't respond to hormone treatments. The goal is to find out if the drug can help control the cancer's growth and spread.

Do I need to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

This trial is for men with advanced prostate cancer that has spread and doesn't respond to hormone therapy. They should be relatively healthy, able to perform daily activities (ECOG 0-1), and have a PSA level of at least 2 ng/mL. Men can't join if they have serious health issues, brain metastases, or significant heart disease.

Inclusion Criteria

You must have a Prostate Specific Antigen level of at least 2 nanograms per milliliter during the screening process.

My prostate cancer has been confirmed by a lab test.

My prostate cancer has worsened despite hormone therapy and at least one other treatment.

Exclusion Criteria

Participant must not have any significant medical condition, including active or uncontrolled infection, psychiatric illness, or the presence of laboratory abnormalities, which places the participant at unacceptable risk or prevent participation in the study based on Investigator assessment.

I have never had cancer spread to my brain.

My heart is healthy and I don't have significant heart disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BMS-986460 to assess safety, tolerability, and preliminary efficacy

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• BMS-986460

Trial Overview The study is testing BMS-986460's safety and early effectiveness in treating metastatic castration-resistant prostate cancer. Participants will receive this investigational drug to see how well it works and what side effects it may cause.

Participant Groups

Group I: Administration of BMS-986460 Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania