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New hope for Hard-to-Treat cancers: experimental drug BMS-986523 enters human trials

NCT ID NCT07223047

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests a new drug called BMS-986523, alone or with other cancer drugs, in people with advanced solid tumors (like lung, colorectal, or pancreatic cancer) that have a specific genetic change (KRAS mutation). The goal is to see if it is safe and works. About 252 adults will take part.

What this could mean

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

Active substance
BMS-986523
What this could lead to
If successful, this could point toward a new treatment option for people with advanced solid tumors that have KRAS mutations.
What could go wrong
This is an early-phase trial (Phase 1/2a) with a small number of participants, so safety and effectiveness are not yet proven. The drug may cause side effects or not work as hoped.

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 252 people

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

Started

Nov 2025

Expected to finish

Oct 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 a histologically confirmed diagnosis of a locally advanced and unresectable or metastatic solid tumor malignancy with a known Kirsten rat sarcoma viral oncogene homolog (KRAS) alteration (mutation or amplification). * Participants must, for Arm D, have a PD-L1 expression (≥50%). * Participants must have previously received, be ineligible for, or decline (after having been provided adequate information to make an informed decision) the protocol defined standard of care (SoC) treatments. Exclusion Criteria * Participants must not have untreated central nervous system (CNS) metastases. * Participants must not have concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment. * Participants must not have a history of, or any evidence of, interstitial lung disease or active, non-infectious pneumonitis. A history of radiation pneumonitis in the radiation field is permitted. * Participants must not have a history of prior severe cutaneous adverse reactions (SCARs), including Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN). * Other protocol-defined Inclusion/Exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

cancer colorectal cancer colorectal neoplasm lung neoplasm non-small cell lung carcinoma pancreatic ductal adenocarcinoma pancreatic neoplasm

As listed by the trial registrant

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

Advanced solid malignancies Colorectal cancer (CRC) Non-small cell lung cancer (NSCLC) Pancreatic ductal adenocarcinoma (PDAC)

How to take part

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

  1. The places running it

    8 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

  • BC Cancer Vancouver

    RECRUITING

    Vancouver, British Columbia, V5Z 4E6, Canada

  • Johns Hopkins Hospital

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Local Institution - 0006

    NOT_YET_RECRUITING

    Badalona, Barcelona [Barcelona], 08916, Spain

  • Local Institution - 0008

    NOT_YET_RECRUITING

    Hortaleza, Madrid, 28050, Spain

  • NEXT Oncology

    RECRUITING

    San Antonio, Texas, 78229, United States

  • NEXT Virginia

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Princess Margaret Cancer Centre

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • START Mountain Region

    RECRUITING

    West Valley City, Utah, 84119, United States

More trials for these conditions

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