BMS-986460 for Prostate Cancer

Not currently recruiting at 13 trial locations
BS
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Overseen ByFirst 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
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called BMS-986460, an experimental drug for men with metastatic castration-resistant prostate cancer. This type of cancer continues to grow despite hormone therapy. The trial's main goal is to determine the treatment's safety and effectiveness. It suits those diagnosed with prostate cancer that has spread and who have not responded to standard hormone treatments. Participants should not have brain metastases or serious heart problems. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive it.

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.

Is there any evidence suggesting that BMS-986460 is likely to be safe for humans?

Research has shown that BMS-986460 is in the early stages of testing with people. Scientists are primarily assessing its safety and how well the body tolerates it. Due to its early testing phase, limited information exists on how this treatment affects people.

In early studies like this, only a few participants initially receive the treatment. Scientists closely monitor for any adverse reactions or side effects. As a new treatment, its tolerability and potential side effects remain uncertain.

Prospective trial participants should discuss with the study team. They can provide more details on what to expect and address any safety concerns.12345

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for prostate cancer, such as hormone therapy, chemotherapy, or radiation, BMS-986460 offers a unique approach by potentially targeting specific pathways involved in cancer growth with a novel mechanism of action. Researchers are excited about BMS-986460 because it represents a new class of drugs that could provide an alternative when existing options may not be effective or suitable. This treatment could offer new hope for patients by addressing prostate cancer in a way that current therapies do not, potentially leading to better outcomes with different side effect profiles.

What evidence suggests that BMS-986460 might be an effective treatment for prostate cancer?

Research shows that BMS-986460, the investigational treatment studied in this trial, might help treat a type of prostate cancer that has spread and resists usual hormone treatments. This drug targets specific processes that aid cancer cell survival and growth. Early studies suggest that BMS-986460 could shrink tumors and slow cancer progression. Although extensive data is not yet available, initial results are promising and suggest potential effectiveness for this challenging cancer.25678

Who Is on the Research Team?

BS

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

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.
See 1 more

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Administration of BMS-986460Experimental Treatment1 Intervention

Find a Clinic Near You

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 profile image

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 profile image

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

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

Citations

NCT06067841 | A Study to Assess BMS-986460 in ...The purpose of this study is to assess the safety, tolerability, and preliminary efficacy of BMS-986460 in men with Metastatic Castration-resistant Prostate ...
A Study to Assess BMS-986460 in Participants ...The purpose of this study is to assess the safety, tolerability, and preliminary efficacy of BMS-986460 in men with Metastatic Castration-resistant Prostate ...
BMS-986460 for Prostate Cancer · Info for ParticipantsThis 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 ...
Prostate Cancer trials in Durham, North CarolinaA Study to Assess BMS-986460 in Participants With Metastatic Castration-resistant Prostate Cancer. purpose of this study is to assess the safety, tolerability, ...
A Study to Assess BMS-986460 in Participants ...The purpose of this study is to assess the safety, tolerability, and preliminary efficacy of BMS-986460 in men with Metastatic Castration-resistant Prostate ...
NCT06067841 | A Study to Assess BMS-986460 in ...The purpose of this study is to assess the safety, tolerability, and preliminary efficacy of BMS-986460 in men with Metastatic Castration-resistant Prostate ...
A Study to Assess BMS-986460 in Participants With Metastatic ...The purpose of this study is to assess the safety, tolerability, and preliminary efficacy of BMS-986460 in men with Metastatic Castration-resistant Prostate ...
A Study to Assess BMS-986460 in Participants With Metastatic ...A phase of research to describe clinical trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the goal is to ...
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