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)

Johns Hopkins Hospital

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

BC Cancer Vancouver

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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