Clinical trial Recruiting at 18 sites Phase 1 Interventional Ages 18 and up

BMS-986500 alone or with other therapies for advanced solid tumors

Official title: 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

Run by Bristol-Myers Squibb · NCT06997029 · Data updated 2026-11-12

This trial will test whether BMS-986500 by itself or combined with palbociclib and fulvestrant can help adults with advanced solid tumors, including breast and ovarian cancers, especially after CDK4/6 inhibitor treatment.

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment234 (estimated)
SponsorBristol-Myers Squibb
Industry-sponsored
Locations21 sites (Birmingham, Alabama and 20 other locations)
StatusRecruiting
StartedAugust 1, 2025
Main results expectedDecember 14, 2028
Study endsDecember 14, 2028
Registry record updatedOctober 6, 2026
Trial IDNCT06997029 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (≥18) with histologically confirmed advanced, unresectable, or metastatic solid tumors with measurable disease and ECOG 0–1 are the main candidates, with specific cohorts for CDK4/6-pretreated breast cancer and CCNE1-amplified ovarian cancer in Part 2A.

Probably not a fit

Patients with active brain metastases, significant cardiac disease, recent clinically significant bleeding, Grade ≥2 peripheral neuropathy, or other protocol-defined exclusions are unlikely to be eligible or to benefit from participation.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1, open-label trial testing BMS-986500 as monotherapy in adults with advanced, unresectable, or metastatic solid tumors and as combination therapy in selected breast and ovarian cancer cohorts. The study uses dose-escalation and expansion cohorts to define safety, tolerability, and an appropriate dose, with tumor response measured by RECIST v1.1. Part 2A specifically enrolls patients with CCNE1-amplified ovarian cancer, while combination arms focus on patients previously treated with CDK4/6 inhibitors. Eligible participants must be adults with measurable disease and ECOG performance status 0–1, and the protocol excludes patients with active brain metastases, significant cardiac disease, recent major bleeding, or high-grade neuropathy.

Why it matters

Potential benefit: If successful, this approach could offer a new treatment option for people with advanced solid tumors and a targeted combo option for breast and CCNE1-amplified ovarian cancers after CDK4/6 therapy.

How similar studies have gone: Other early-phase targeted-agent combinations have shown preliminary activity in advanced cancers, but BMS-986500 is in early human testing and has limited prior clinical data.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • University of Alabama at Birmingham
    Birmingham, Alabama, United States
    Recruiting
  • Providence St. Jude Medical Center
    Fullerton, California, United States
    Recruiting
  • Marin Cancer Care
    Greenbrae, California, United States
    Recruiting
  • Moores Cancer Center
    La Jolla, California, United States
    Recruiting
  • Hoag Memorial Hospital Presbyterian
    Newport Beach, California, United States
    Recruiting
  • Washington University School of Medicine
    St Louis, Missouri, United States
    Recruiting
Show 15 more locations
  • Dartmouth-Hitchcock Medical Center
    Lebanon, New Hampshire, United States
    Recruiting
  • Roswell Park Cancer Institute
    Buffalo, New York, United States
    Recruiting
  • Northwell Health-Cancer Institute
    New Hyde Park, New York, United States
    Recruiting
  • Memorial Sloan Kettering Cancer Center
    New York, New York, United States
    Recruiting
  • START Dallas Fort Worth
    Fort Worth, Texas, United States
    Recruiting
  • NEXT Oncology
    San Antonio, Texas, United States
    Recruiting
  • Odense Universitetshospital
    Odense, Region Syddanmark, Denmark
    Recruiting
  • Copenhagen University Hospital
    Copenhagen, Denmark
    Recruiting
  • National Cancer Center Hospital East
    Kashiwa, Chiba, Japan
    Recruiting
  • Kansai Medical University Hospital
    Hirakata, Osaka, Japan
    Recruiting
  • National Cancer Center Hospital
    Chuo-ku, Tokyo, Japan
    Recruiting
  • The Cancer Institute Hospital of JFCR
    Koto-ku, Tokyo, Japan
    Recruiting
  • Local Institution - 0008
    Aurora, Colorado, United States
    Not yet recruiting
  • Local Institution - 0006
    Boston, Massachusetts, United States
    Completed
  • Local Institution - 0011
    New York, New York, United States
    Not yet recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.