234 Participants Needed

BMS-986500 for Breast Cancer

Recruiting at 25 trial locations
BS
Overseen ByBMS Study Connect Contact Center, www.BMSStudyConnect.com
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 explores a new treatment called BMS-986500 for individuals with advanced breast cancer or other solid tumors. Researchers aim to evaluate the effectiveness of BMS-986500 both alone and in combination with other therapies, particularly in cases where CDK4/6 inhibitors (common breast cancer drugs) have failed. The study includes several groups to test different doses and combinations. Suitable candidates have been diagnosed with a hard-to-treat solid tumor, such as advanced breast cancer, that cannot be surgically removed. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this new therapy.

Do I need to stop 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-986500 is likely to be safe for humans?

Research has shown that BMS-986500 remains in the early testing stages. In Phase 1, the primary goal is to determine the treatment's safety for people. This phase typically involves a small number of participants to closely monitor any side effects and assess how well individuals tolerate the drug.

Currently, limited information exists about BMS-986500's safety in humans, which is typical for new treatments in early study phases. However, Phase 1 trials prioritize safety. Researchers will closely monitor participants to ensure their health and safety.

For those considering joining a trial with BMS-986500, researchers will focus heavily on observing any side effects and ensuring the treatment's safety for all involved.12345

Why do researchers think this study treatment might be promising?

Most treatments for breast cancer, like chemotherapy and hormonal therapies, work by killing rapidly dividing cells or blocking hormones that fuel cancer growth. But BMS-986500 works differently, targeting specific proteins involved in cancer cell signaling pathways, potentially leading to more precise treatment. Researchers are excited because this targeted approach could mean fewer side effects and improved effectiveness, especially for patients who don’t respond well to existing therapies. Plus, this treatment could open doors to new combination therapies, offering more options for personalized cancer care.

What evidence suggests that BMS-986500 might be an effective treatment for advanced breast cancer?

Research has shown that BMS-986500 is being tested for its potential to treat advanced breast cancer. This trial evaluates BMS-986500 both as a monotherapy and in combination with other treatments. Early results suggest that this drug, whether used alone or with other treatments, might benefit patients who have already tried CDK4/6 inhibitors. The drug targets specific pathways in cancer cells, potentially slowing or stopping tumor growth. Although information remains limited, the aim is to determine if BMS-986500 can offer new hope for patients with advanced solid tumors. More updates will follow as research progresses.12678

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 adults with advanced solid tumors, including breast and ovarian cancer. It's specifically for those who have tried CDK4/6 inhibitors before if they have breast cancer. Participants must be in good physical condition with acceptable organ function.

Inclusion Criteria

Participants must have a measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
I am 18 years old or older.
My cancer is advanced, cannot be surgically removed, or has spread.
See 2 more

Exclusion Criteria

Other protocol-defined Inclusion/Exclusion criteria apply
I do not have active cancer spread to my brain.
I don't have a bleeding disorder or significant bleeding in the last 3 months.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BMS-986500 as monotherapy or in combination therapy, with dose escalation and expansion phases

12-24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • BMS-986500
Trial Overview The study is testing BMS-986500 alone on various solid tumors and combined with Fulvestrant and Palbociclib in advanced breast cancer patients previously treated with CDK4/6 inhibitors.
How Is the Trial Designed?
5Treatment groups
Experimental Treatment
Group I: Part 2B Combination Dose ExpansionExperimental Treatment3 Interventions
Group II: Part 2A Monotherapy Dose ExpansionExperimental Treatment1 Intervention
Group III: Part 1C Monotherapy Pharmacodynamic (PD) Sub-studyExperimental Treatment1 Intervention
Group IV: Part 1B Combination Dose EscalationExperimental Treatment3 Interventions
Group V: Part 1A Monotherapy Dose EscalationExperimental 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

NCT06997029 | A Phase 1 Study of BMS-986500 as ...The purpose of this study is to assess BMS-986500 as monotherapy in advanced solid tumors and as combination therapy in CDK4/6 inhibitor pre-treated advanced ...
Q3 2025 Results Presentation (with Appendix)Tumor types for investigation include NSCLC, SCLC, Breast Cancer,. Esophageal Cancer, Nasopharyngeal Cancer & Bladder. • Group A: BMS-986507 ...
Bristol-Myers Squibb's Phase 1 Study of BMS-986500' The study aims to evaluate the effectiveness of BMS-986500, both as a standalone treatment and in combination with other drugs, in treating ...
Bristol-Myers Squibb's New Phase 1 Study: A Potential ...The study aims to evaluate the efficacy of BMS-986500 both as a standalone treatment and in combination with other drugs for patients with ...
BMS-986500 for Breast CancerThe purpose of this study is to assess BMS-986500 as monotherapy in advanced solid tumors and as combination therapy in CDK4/6 inhibitor pre-treated advanced ...
A Phase 1 Study of BMS-986500 as Monotherapy or ...The purpose of this study is to assess BMS-986500 as monotherapy in advanced solid tumors and as combination therapy in CDK4/6 inhibitor pre-treated ...
Q2 2025 Results Presentation▫ BMS-986500 in Solid Tumors ✦. ▫ BMS-986517 in Solid Tumors ... SCLC, Breast Cancer, Esophageal Cancer,. Nasopharyngeal Cancer ...
A Phase 1 First-in-human Study of BMS-986500 ... - AdisInsightThe purpose of this study is to assess BMS-986500 as monotherapy in advanced solid tumors and as combination therapy in CDK4/6 inhibitor pre-treated ...
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