RecruitingPhase 1Phase 2NCT07223047

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

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


Sponsor

Bristol-Myers Squibb

Enrollment

252 participants

Start Date

Nov 25, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called BMS-986523 — alone or combined with other cancer drugs — in adults with advanced solid tumors (cancers in organs or tissues, not blood cancers) that have a specific genetic change in a gene called KRAS. KRAS mutations are found in many cancers and have historically been difficult to treat. **You may be eligible if...** - You are an adult with a solid tumor cancer that has been confirmed by biopsy - Your tumor has been tested and found to have a KRAS mutation or KRAS amplification - You have already tried standard treatments, are not eligible for them, or have chosen not to receive them after full discussion with your doctor - For one particular treatment arm (Arm D): your tumor must express a high level of a protein called PD-L1 (50% or more) **You may NOT be eligible if...** - You have brain metastases that have not yet been treated - You have another active cancer requiring treatment, or had a cancer within the past 2 years - You have a history of serious lung inflammation (interstitial lung disease or pneumonitis) - You have had a prior severe skin reaction to any drug (such as Stevens-Johnson Syndrome) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBMS-986523

Specified dose on specified days

DRUGGemcitabine

Specified dose on specified days

DRUGNab-Paclitaxel

Specified dose on specified days

DRUGCetuximab

Specified dose on specified days

DRUGPembrolizumab

Specified dose on specified days


Locations(8)

Local Institution - 0009

Baltimore, Maryland, United States

NEXT Oncology

San Antonio, Texas, United States

START Mountain Region

West Valley City, Utah, United States

NEXT Virginia

Fairfax, Virginia, United States

Local Institution - 0002

Vancouver, British Columbia, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Local Institution - 0006

Badalona, Barcelona [Barcelona], Spain

Local Institution - 0008

Hortaleza, Madrid, Spain

View Full Details on ClinicalTrials.gov

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NCT07223047


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