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NCT06997029PHASE1Recruiting

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

Bristol-Myers Squibb

Start Date

8/1/2025

Completion Date

12/14/2028

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 Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Participants must be ≥ 18 years of age. * Participants must have histologically confirmed diagnosis of a locally advanced, unresectable, or metastatic solid tumor malignancy. * Participants must have a measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 * Participants must have a stable Eastern Cooperative Oncology Group Performance Status of 0 or 1. * For Part 2A only, participants must have CCNE1-amplified ovarian cancer Exclusion Criteria: * Participants must not have an active brain metastasis. * Participants must not have impaired cardiac function or clinically significant cardiac disease. * Participants must not have bleeding disorder or any history of clinically significant bleeding within the prior 3 months. * Participants must not have Grade ≥ 2 peripheral neuropathy. * Other protocol-defined Inclusion/Exclusion criteria apply.

Interventions

DRUG

BMS-986500

DRUG

Palbociclib

DRUG

Fulvestrant

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Conditions

Advanced Solid TumorAdvanced Breast CancerAdvanced Ovarian Cancer

Locations

University of Alabama at Birmingham

Birmingham, Alabama 35294-3300

United States

Providence St. Jude Medical Center

Fullerton, California 92835

United States

Marin Cancer Care

Greenbrae, California 94904

United States

Moores Cancer Center

La Jolla, California 92093

United States

Hoag Memorial Hospital Presbyterian

Newport Beach, California 92663

United States

Local Institution - 0008

Aurora, Colorado 80045

United States

Dana-Farber Cancer Institute

Boston, Massachusetts 02215

United States

Washington University School of Medicine

St Louis, Missouri 63110

United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire 03756

United States

Roswell Park Cancer Institute

Buffalo, New York 14263

United States

Northwell Health-Cancer Institute

New Hyde Park, New York 11042

United States

Local Institution - 0011

New York, New York 10016

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States

START Dallas Fort Worth

Fort Worth, Texas 76104

United States

NEXT Oncology

San Antonio, Texas 78229

United States

Odense Universitetshospital

Odense, Region Syddanmark 5000

Denmark

Copenhagen University Hospital

Copenhagen, 2100

Denmark

National Cancer Center Hospital East

Kashiwa, Chiba 277-8577

Japan

Kansai Medical University Hospital

Hirakata, Osaka 573-1191

Japan

National Cancer Center Hospital

Chuo-ku, Tokyo 104-0045

Japan

The Cancer Institute Hospital of JFCR

Koto-ku, Tokyo 135-8550

Japan