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

NCT06997029 · tracked via the Priya Life Science USA tracker

Sponsor

Bristol-Myers Squibb

Phase

Phase 1

Started

2025-08-01

Last updated

2026-07-10

Condition(s) studied

Advanced Solid TumorAdvanced Breast CancerAdvanced Ovarian Cancer

Investigational drug(s) / intervention(s)

BMS-986500PalbociclibFulvestrant

BMS-986500: Specified dose of specified days

Palbociclib: Specified dose on specified days

Fulvestrant: Specified dose on specified days

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Number of Participants With Dose Limiting Toxicities (DLTs) — Up to Day 28 From Last Dose
Number of Participants With Adverse Events (AEs) — Up to Day 28 From Last Dose
Number of Participants With Serious Adverse Events (SAEs) — Up to Day 28 From Last Dose
Number of Participants With AEs Leading to Discontinuation — Up to Day 28 From Last Dose
Number of Participants With TEAEs Leading to Death — Up to Day 28 From Last Dose

Trial sites (21)

Facility	City	Region	Status
University of Alabama at Birmingham	Birmingham	Alabama	Recruiting
Providence St. Jude Medical Center	Fullerton	California	Recruiting
Marin Cancer Care	Greenbrae	California	Recruiting
Moores Cancer Center	La Jolla	California	Recruiting
Hoag Memorial Hospital Presbyterian	Newport Beach	California	Recruiting
Local Institution - 0008	Aurora	Colorado	Not Yet Recruiting
Dana-Farber Cancer Institute	Boston	Massachusetts	Recruiting
Washington University School of Medicine	St Louis	Missouri	Recruiting
Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	Recruiting
Roswell Park Cancer Institute	Buffalo	New York	Recruiting
Northwell Health-Cancer Institute	New Hyde Park	New York	Recruiting
Local Institution - 0011	New York	New York	Not Yet Recruiting
Memorial Sloan Kettering Cancer Center	New York	New York	Recruiting
START Dallas Fort Worth	Fort Worth	Texas	Recruiting
NEXT Oncology	San Antonio	Texas	Recruiting
Odense Universitetshospital	Odense	Region Syddanmark	Recruiting
Copenhagen University Hospital	Copenhagen	Denmark	Recruiting
National Cancer Center Hospital East	Kashiwa	Chiba	Recruiting
Kansai Medical University Hospital	Hirakata	Osaka	Recruiting
National Cancer Center Hospital	Chuo-ku	Tokyo	Recruiting
The Cancer Institute Hospital of JFCR	Koto-ku	Tokyo	Recruiting

On this site

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06997029 on ClinicalTrials.gov ↗ ← All trials in the USA