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New experimental drug BMS-986500 enters first human trials for advanced cancers

NCT ID NCT06997029

Disease control Sponsor: Bristol-Myers Squibb Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 10, 2026 · Updated 3 times

Summary

This early-stage trial is testing an experimental drug called BMS-986500 in people with advanced solid tumors or breast cancer that has not responded to prior treatments. The study will first test the drug alone, then in combination with other cancer drugs (palbociclib and fulvestrant) for breast cancer patients. The main goals are to check safety, find the right dose, and see how the body processes the drug. About 234 participants are being recruited.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BMS-986500 (an experimental drug)
What this could lead to
If successful, this could point toward a new treatment option for advanced solid tumors and breast cancer that has stopped responding to other therapies.
What could go wrong
This is a very early Phase 1 trial focused on safety and dosing, not effectiveness. The drug may not work or could have serious side effects. Results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 234 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma neoplasm ovarian cancer ovarian carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced breast cancer Advanced ovarian cancer Advanced solid tumor

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    21 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Copenhagen University Hospital

    RECRUITING

    Copenhagen, 2100, Denmark

  • Dana-Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Dartmouth-Hitchcock Medical Center

    RECRUITING

    Lebanon, New Hampshire, 03756, United States

  • Hoag Memorial Hospital Presbyterian

    RECRUITING

    Newport Beach, California, 92663, United States

  • Kansai Medical University Hospital

    RECRUITING

    Hirakata, Osaka, 573-1191, Japan

  • Local Institution - 0008

    NOT_YET_RECRUITING

    Aurora, Colorado, 80045, United States

  • Local Institution - 0011

    NOT_YET_RECRUITING

    New York, New York, 10016, United States

  • Marin Cancer Care

    RECRUITING

    Greenbrae, California, 94904, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • Moores Cancer Center

    RECRUITING

    La Jolla, California, 92093, United States

  • NEXT Oncology

    RECRUITING

    San Antonio, Texas, 78229, United States

  • National Cancer Center Hospital

    RECRUITING

    Chuo-ku, Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East

    RECRUITING

    Kashiwa, Chiba, 277-8577, Japan

  • Northwell Health-Cancer Institute

    RECRUITING

    New Hyde Park, New York, 11042, United States

  • Odense Universitetshospital

    RECRUITING

    Odense, Region Syddanmark, 5000, Denmark

  • Providence St. Jude Medical Center

    RECRUITING

    Fullerton, California, 92835, United States

  • Roswell Park Cancer Institute

    RECRUITING

    Buffalo, New York, 14263, United States

  • START Dallas Fort Worth

    RECRUITING

    Fort Worth, Texas, 76104, United States

  • The Cancer Institute Hospital of JFCR

    RECRUITING

    Koto-ku, Tokyo, 135-8550, Japan

  • University of Alabama at Birmingham

    RECRUITING

    Birmingham, Alabama, 35294-3300, United States

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

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