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New hope for Hard-to-Treat cancers? early trial launches

NCT ID NCT07160725

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 12, 2026 · Updated 3 times

Summary

This early-phase trial is testing a new drug called BMS-986517 in about 315 adults with advanced solid tumors that have spread or cannot be removed by surgery. The main goal is to check the drug's safety and find the right dose. Researchers will also look for signs that the drug shrinks tumors. This is a first-in-human study, so the drug's effects are not yet known.

What this could mean

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

Active substance
BMS-986517
What this could lead to
If successful, this could point toward a new treatment option for certain advanced solid tumors that have not responded to other therapies.
What could go wrong
This is a very early, first-in-human study focused mainly on safety. It is small and may not show enough benefit to move forward. Side effects are unknown.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 540 people

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

Started

Oct 2025

Expected to finish

Aug 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 have an ECOG performance status of 0 to 1. * Participants must have measurable disease by RECIST v1.1 (radiologically measured by the Investigator). * Participants must have documented histologically or cytologically confirmed advanced, unresectable/metastatic solid tumors, including NSCLC, HNSCC, TNBC, and HR+/HER2- breast cancer. Exclusion Criteria * Participants are eligible if CNS metastases have been treated and do not require immediate treatment or have been treated and have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment). * Participants must not have concurrent malignancy (present during Screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment assignment. * Participants must not have history of serious recurrent infections. * Participants must not have impaired cardiac function or history of severe heart disease. * For participants in Part 1B and 2B: Active autoimmune disease or requirement for systemic immunosuppressive therapy. * For participants in Part 1B and 2B: History of interstitial lung disease (ILD) or pneumonitis requiring systemic steroids, or current/suspected ILD/pneumonitis. * For participants in Part 1B and 2B: Significant risk of hemorrhage, including tumor invasion of major vessels or recent clinically significant bleeding. * Other protocol-defined Inclusion/Exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

head and neck squamous cell carcinoma hormone receptor-positive breast cancer non-small cell lung carcinoma triple-negative breast carcinoma

As listed by the trial registrant

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

Solid tumours

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    20 sites in 5 countries. The list below names each one and where it is.

  3. 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 ↗

  4. 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

  • Clinica Universidad de Navarra

    RECRUITING

    Pamplona, Navarre, 31008, Spain

  • Copenhagen University Hospital Rigshospitalet

    RECRUITING

    Copenhagen, 2100, Denmark

  • Fred Hutchinson Cancer Center

    RECRUITING

    Seattle, Washington, 98109, United States

  • Herlev and Gentofte Hospital

    RECRUITING

    Copenhagen, Capital Region, 2730, Denmark

  • Hospital Universitario Fundación Jiménez Díaz

    RECRUITING

    Madrid, 28040, Spain

  • Local Institution - 0022

    NOT_YET_RECRUITING

    Badalona, Barcelona [Barcelona], 08916, Spain

  • Local Institution - 0023

    NOT_YET_RECRUITING

    Madrid, 28050, Spain

  • Local Institution - 0024

    NOT_YET_RECRUITING

    Barcelona, Barcelona [Barcelona], 08035, Spain

  • Local Institution - 0026

    NOT_YET_RECRUITING

    Málaga, Andalusia, 29010, Spain

  • Local Institution - 0033

    NOT_YET_RECRUITING

    Irvine, California, 92612, United States

  • Local Institution - 0034

    NOT_YET_RECRUITING

    Guangzhou, Guangdong, 510120, China

  • National Cancer Center Hospital

    RECRUITING

    Chuo-ku, Tokyo, 104-0045, Japan

  • Odense Universitetshospital

    RECRUITING

    Odense, Region Syddanmark, 5000, Denmark

  • START - Dallas Fort Worth

    RECRUITING

    Fort Worth, Texas, 76104, United States

  • START Mountain Region

    RECRUITING

    West Valley City, Utah, 84119, United States

  • START San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

    Contact Email: •••••@•••••

  • Sanford Cancer Center

    RECRUITING

    Sioux Falls, South Dakota, 57104, United States

  • UPMC Hillman Cancer Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • USC/Norris Comprehensive Cancer Center

    RECRUITING

    Los Angeles, California, 90033, United States

  • University of California, Irvine (UCI) Health - UC Irvine Medical Center

    RECRUITING

    Orange, California, 92868-3201, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.