A Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986523 Alone and in Combination With Anti-Cancer Agents in Participants With Advanced Solid Malignancies

May 26, 2026 updated by: Bristol-Myers Squibb

A Phase 1/2a, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of BMS-986523 As Monotherapy and in Combination With Anti-Cancer Agents in Participants With Advanced Solid Malignancies

The purpose of this study is to evaluate the safety, tolerability, and efficacy of BMS-986523 alone and in combination with anti-cancer agents in participants with advanced solid malignancies

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

252

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: First line of the email MUST contain NCT # and Site #.

Study Contact Backup

  • Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Recruiting
        • BC Cancer Vancouver
        • Contact:
          • Daniel Renouf, Site 0002
          • Phone Number: 6048776000Ext3297
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Princess Margaret Cancer Centre
        • Contact:
          • Albiruni Abdul Razak, Site 0010
          • Phone Number: 6479709845
  • Spain
    • Barcelona [Barcelona]
      • Badalona, Barcelona [Barcelona], Spain, 08916
        • Not yet recruiting
        • Local Institution - 0006
        • Contact:
          • Site 0006
    • Madrid
      • Hortaleza, Madrid, Spain, 28050
        • Not yet recruiting
        • Local Institution - 0008
        • Contact:
          • Site 0008
  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins Hospital
        • Contact:
          • Nilofer Azad, Site 0009
          • Phone Number: 410-502-2995
    • Texas
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Next Oncology
        • Contact:
          • David Sommerhalder, Site 0001
          • Phone Number: 210-580-9500
    • Utah
      • West Valley City, Utah, United States, 84119
        • Recruiting
        • START Mountain Region
        • Contact:
          • Justin Call, Site 0007
          • Phone Number: 801-907-4750
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • NEXT Virginia
        • Contact:
          • Alexander Spira, Site 0011
          • Phone Number: 703-280-5390

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
Drug: BMS-986523
Specified dose on specified days
Experimental: Arm B
Drug: BMS-986523
Specified dose on specified days
Experimental: Arm C
Drug: BMS-986523
Specified dose on specified days
Experimental: Arm D
Drug: Pembrolizumab
Specified dose on specified days
Drug: BMS-986523
Specified dose on specified days
Experimental: Arm E
Drug: Cetuximab
Specified dose on specified days
Drug: BMS-986523
Specified dose on specified days
Experimental: Arm F
Drug: Gemcitabine
Specified dose on specified days
Drug: Nab-Paclitaxel
Specified dose on specified days
Drug: BMS-986523
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events (AEs)
Time Frame: Up to 3 years
Up to 3 years
Number of participants with serious adverse events (SAEs)
Time Frame: Up to 3 years
Up to 3 years
Number of participants with AEs leading to discontinuation
Time Frame: Up to 3 years
Up to 3 years
Number of participants with AEs meeting protocol-defined dose limiting toxicity (DLT) criteria
Time Frame: Up to 3 years
Up to 3 years
Number of deaths
Time Frame: Up to 3 years
Up to 3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by the investigator.
Time Frame: Up to 3 years
Up to 3 years
Duration of response (DOR) per RECIST v1.1 as assessed by the investigator.
Time Frame: Up to 3 years
Up to 3 years
Maximum observed plasma concentration (Cmax)
Time Frame: Up to 3 years
Up to 3 years
Time of maximum observed plasma concentration (Tmax)
Time Frame: Up to 3 years
Up to 3 years
Area under the concentration-time curve in 1 dosing interval (AUC(TAU))
Time Frame: Up to 3 years
Up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 25, 2025

Primary Completion (Estimated)

October 13, 2028

Study Completion (Estimated)

October 13, 2028

Study Registration Dates

First Submitted

October 29, 2025

First Submitted That Met QC Criteria

October 29, 2025

First Posted (Actual)

October 31, 2025

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 26, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA256-0001
  • 2025-523547-35 (Other Identifier: EU CTR)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Non-small Cell Lung Cancer (NSCLC)

Clinical Trials on Pembrolizumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bosnia & Herzegovina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe