BMS-986500 for Breast Cancer

Recruiting at 12 trial locations

Overseen By BMS Study Connect Contact Center, www.BMSStudyConnect.com

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Bristol-Myers Squibb

Disqualifiers: Active brain metastasis, Cardiac disease, Bleeding disorder, Peripheral neuropathy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12-24 weeks

234 Participants Needed

Trial Summary

What is the purpose of this trial?

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 breast cancer.

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

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.

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Part 2B Combination Dose Expansion Experimental Treatment 3 Interventions

Group II: Part 2A Monotherapy Dose Expansion Experimental Treatment 1 Intervention

Group III: Part 1C Monotherapy Pharmacodynamic (PD) Sub-study Experimental Treatment 1 Intervention

Group IV: Part 1B Combination Dose Escalation Experimental Treatment 3 Interventions

Group V: Part 1A Monotherapy Dose Escalation 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