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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

RECRUITINGPhase 1/2Sponsored by Bristol-Myers Squibb
Actively Recruiting
PhasePhase 1/2
SponsorBristol-Myers Squibb
Started2025-11-25
Est. completion2028-10-13
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations4 sites

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

Age: 18 Years+Healthy volunteers accepted
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.

Conditions6

Advanced Solid MalignanciesCancerColorectal Cancer (CRC)Lung CancerNon-small Cell Lung Cancer (NSCLC)Pancreatic Ductal Adenocarcinoma (PDAC)

Locations4 sites

Maryland

1 site
Local Institution - 0009
Baltimore, Maryland, 21287
Site 0009

Texas

1 site
NEXT Oncology
San Antonio, Texas, 78229
David Sommerhalder, Site 0001210-580-9500

Utah

1 site
Local Institution - 0007
Salt Lake City, Utah, 84124
Site 0007

Virginia

1 site
NEXT Virginia
Fairfax, Virginia, 22031
Alexander Spira, Site 0011703-280-5390

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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