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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
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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.
About the study
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
What is being tested
- BMS-986523 (drug)
- Gemcitabine (drug)
- Nab-Paclitaxel (drug)
- Cetuximab (drug)
- Pembrolizumab (drug)
Sponsor: Bristol-Myers Squibb · Participants: 252 · Started: Nov 25, 2025
Contact the study team
- BMS Clinical Trials Contact Center www.BMSClinicalTrials.com · Phone: 855-907-3286
Official record on ClinicalTrials.gov — NCT07223047
Locations in the U.S.
| Maryland | Johns Hopkins Hospital, Baltimore |
| Texas | NEXT Oncology, San Antonio |
| Utah | START Mountain Region, West Valley City |
| Virginia | NEXT Virginia, Fairfax |
Conditions
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.