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NCT07223047PHASE1, PHASE2Recruiting

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

Bristol-Myers Squibb

Start Date

11/25/2025

Completion Date

10/13/2028

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 Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

BMS-986523

DRUG

Gemcitabine

DRUG

Nab-Paclitaxel

DRUG

Cetuximab

DRUG

Pembrolizumab

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Conditions

Advanced Solid MalignanciesNon-small Cell Lung Cancer (NSCLC)Colorectal Cancer (CRC)Pancreatic Ductal Adenocarcinoma (PDAC)

Locations

Johns Hopkins Hospital

Baltimore, Maryland 21287

United States

NEXT Oncology

San Antonio, Texas 78229

United States

START Mountain Region

West Valley City, Utah 84119

United States

NEXT Virginia

Fairfax, Virginia 22031

United States

BC Cancer Vancouver

Vancouver, British Columbia V5Z 4E6

Canada

Princess Margaret Cancer Centre

Toronto, Ontario M5G 2M9

Canada

Local Institution - 0006

Badalona, Barcelona [Barcelona] 08916

Spain

Local Institution - 0008

Hortaleza, Madrid 28050

Spain