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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
View on ClinicalTrials.gov →
NCT07223047
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)
Interventions5
Locations4 sites
Texas
1 siteUtah
1 siteSTART Mountain Region
West Valley City, Utah, 84119
Justin Call, Site 0007801-907-4750
Virginia
1 siteFind trials near these locations
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Actively Recruiting
PhasePhase 1/2
SponsorBristol-Myers Squibb
Started2025-11-25
Est. completion2028-10-13
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations4 sites
View on ClinicalTrials.gov →
NCT07223047