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

Recruiting now · Phase 1/Phase 2

Conditions studied: Advanced Solid Malignancies, Non-small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Pancreatic Ductal Adenocarcinoma (PDAC)

In brief

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

Key facts

Study ID

NCT07223047

Run by

Bristol-Myers Squibb

People needed

252

Starts

2025-11-25

Expected to finish

2028-10-13

Last updated by the study team

2026-05-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Johns Hopkins Hospital — Baltimore, Maryland, United States (enrolling)
• NEXT Oncology — San Antonio, Texas, United States (enrolling)
• START Mountain Region — West Valley City, Utah, United States (enrolling)
• NEXT Virginia — Fairfax, Virginia, United States (enrolling)
• BC Cancer Vancouver — Vancouver, British Columbia, Canada (enrolling)
• Princess Margaret Cancer Centre — Toronto, Ontario, Canada (enrolling)
• Local Institution - 0006 — Badalona, Barcelona [Barcelona], Spain
• Local Institution - 0008 — Hortaleza, Madrid, Spain

Full record on ClinicalTrials.gov

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