RecruitingPhase 1NCT06997029

A Phase 1 Study of BMS-986500 as Monotherapy or Combination Therapy in Advanced Solid Tumors

A Phase 1 First-in-human Study of BMS-986500 as Monotherapy in Advanced Solid Tumors and as Combination Therapy in CDK4/6 Inhibitor Pre-treated Advanced Breast Cancer

Sponsor

Bristol-Myers Squibb

Enrollment

234 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

Advanced Solid Tumor Advanced Breast Cancer Advanced Ovarian Cancer

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study tests BMS-986500, a new experimental drug, either alone or in combination with other drugs, in people with advanced solid tumors (cancers that have spread and cannot be surgically removed) that have not responded to standard treatments. **You may be eligible if...** - You are 18 or older with a confirmed advanced solid tumor that cannot be removed by surgery - Your cancer has measurable disease on imaging - You are in reasonably good physical condition (ECOG 0 or 1) - For one specific sub-study group: you have CCNE1-amplified ovarian cancer **You may NOT be eligible if...** - You have active cancer spread to the brain - You have impaired heart function or a clinically significant heart disease - You have a bleeding disorder or had significant bleeding in the last 3 months - You have moderate to severe nerve damage in your hands or feet (Grade 2+) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBMS-986500

Specified dose of specified days

DRUGPalbociclib

Specified dose on specified days

DRUGFulvestrant

Specified dose on specified days

Locations(21)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Providence St. Jude Medical Center

Fullerton, California, United States

Marin Cancer Care

Greenbrae, California, United States

Moores Cancer Center

La Jolla, California, United States

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States

Local Institution - 0008

Aurora, Colorado, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Washington University School of Medicine

St Louis, Missouri, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Northwell Health-Cancer Institute

New Hyde Park, New York, United States

Local Institution - 0011

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

START Dallas Fort Worth

Fort Worth, Texas, United States

NEXT Oncology

San Antonio, Texas, United States

Odense Universitetshospital

Odense, Region Syddanmark, Denmark

Local Institution - 0025

Copenhagen, Denmark

National Cancer Center Hospital East

Kashiwa, Chiba, Japan

Kansai Medical University Hospital

Hirakata, Osaka, Japan

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

The Cancer Institute Hospital of JFCR

Koto-ku, Tokyo, Japan

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06997029

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