BMS-986523 alone and with other cancer medicines for advanced KRAS-altered solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Bristol-Myers Squibb is running a phase 1/2 program of the investigational agent BMS-986523 given alone or together with agents such as gemcitabine, nab‑paclitaxel, cetuximab, or pembrolizumab in adults with unresectable or metastatic solid tumors that have KRAS alterations. Phase 1 focuses on safety, tolerability, and dose-finding while phase 2 explores preliminary anti-tumor activity across disease-specific arms including NSCLC, CRC, and PDAC, with one arm requiring PD-L1 ≥50%. Key outcomes include adverse events, tolerability, and measures of tumor response and disease control. Eligible participants must have a confirmed KRAS mutation or amplification and have received, be ineligible for, or decline standard treatments.

Why it matters

Who can join: the full rules

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.

Where it's running

• Johns Hopkins Hospital
  Baltimore, Maryland, United States Recruiting
• NEXT Oncology
  San Antonio, Texas, United States Recruiting
• START Mountain Region
  West Valley City, Utah, United States Recruiting
• NEXT Virginia
  Fairfax, Virginia, United States Recruiting
• BC Cancer Vancouver
  Vancouver, British Columbia, Canada Recruiting
• Princess Margaret Cancer Centre
  Toronto, Ontario, Canada Recruiting

Study contacts

• Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
• Email: Clinical.Trials@bms.com
• Phone: 855-907-3286

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.