ClinicalTrialsFinder
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 TumorAdvanced Breast CancerAdvanced 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

Inclusion Criteria5

  • 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 Criteria4

  • 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.

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

Local Institution - 0014

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

Local Institution - 0024

Odense, Region Syddanmark, Denmark

Local Institution - 0025

Copenhagen, Denmark

Local Institution - 0021

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.

Visit

NCT06997029

Related Trials

A Study of Disitamab Vedotin With Other Anticancer Drugs in Solid Tumors

NCT06157892139 locations

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer

NCT066493311 location

Phase 1/2 Study of ETX-636 in Participants With Advanced Solid Tumors

NCT0699384410 locations

Engage Psychosocial Intervention for Cancer Symptoms

NCT065555881 location

Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors

NCT042224132 locations