Recruiting
Phase 1

BMS-986500

Sponsor:

Bristol-Myers Squibb

Code:

NCT06997029

Conditions

Advanced Solid Tumor

Advanced Breast Cancer

Advanced Ovarian Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BMS-986500

Palbociclib

Fulvestrant

Study Details

Brief 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.

Conditions

Advanced Solid Tumor

Advanced Breast Cancer

Advanced Ovarian Cancer

Study ID

NCT06997029

Start date

Aug 1, 2025

Status verified date

Jul, 2026

Completion date

Dec 14, 2028

Anticipated

Primary completion date

Dec 14, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

234 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1A Monotherapy Dose Escalation

experimental: Part 1B Combination Dose Escalation

experimental: Part 1C Monotherapy Pharmacodynamic (PD) Sub-study

experimental: Part 2A Monotherapy Dose Expansion

experimental: Part 2B Combination Dose Expansion

Interventions

BMS-986500

Specified dose of specified days

Palbociclib

Specified dose on specified days

Fulvestrant

Specified dose on specified days

Primary outcome measure

  • Number of Participants With Dose Limiting Toxicities (DLTs) [ Time Frame: Up to Day 28 From Last Dose ]
  • Number of Participants With Adverse Events (AEs) [ Time Frame: Up to Day 28 From Last Dose ]
  • Number of Participants With Serious Adverse Events (SAEs) [ Time Frame: Up to Day 28 From Last Dose ]
  • Number of Participants With AEs Leading to Discontinuation [ Time Frame: Up to Day 28 From Last Dose ]
  • Number of Participants With TEAEs Leading to Death [ Time Frame: Up to Day 28 From Last Dose ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, www.BMSStudyConnect.com

855-907-3286Clinical.Trials@bms.com

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294-3300

Contacts

Mehmet Akce, Site 0001

205-975-0832

Providence St. Jude Medical Center

Recruiting

Fullerton, California, United States, 92835

Contacts

Yung Lyou, Site 0003

714-446-5900

Marin Cancer Care

Recruiting

Greenbrae, California, United States, 94904

Contacts

Cyrus Mazidi, Site 0013

415-925-5000

Moores Cancer Center

Recruiting

La Jolla, California, United States, 92093

Contacts

Peter Vu, Site 0009

858-822-2463

Hoag Memorial Hospital Presbyterian

Recruiting

Newport Beach, California, United States, 92663

Contacts

Monica Mita, Site 0010

949-764-4060

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Joyce Liu, Site 0006

617-632-5269

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Dartmouth-Hitchcock Medical Center

Recruiting

Lebanon, New Hampshire, United States, 03756

Contacts

Lionel Lewis, Site 0002

603-381-1953

Roswell Park Cancer Institute

Recruiting

Buffalo, New York, United States, 14263

Contacts

Christos Fountzilas, Site 0014

716-845-4720

Northwell Health-Cancer Institute

Recruiting

New Hyde Park, New York, United States, 11042

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Ezra Rosen, Site 0012

000-000-0000

START Dallas Fort Worth

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

Henry Xiong, Site 0018

682-350-3010

NEXT Oncology

Recruiting

San Antonio, Texas, United States, 78229

Contacts

David Sommerhalder, Site 0007

210-580-9500

More Information

Sponsor

Bristol-Myers Squibb

Last update posted

Jul 10, 2026

Last verified

Jul, 2026

Keywords

  • cancer
  • oncology
  • solid tumor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Bristol-Myers Squibb on 2026-07-10.