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Recruiting Phase 3

Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma

NCT07562152 · tracked via the Priya Life Science USA tracker
Phase
Phase 3
Started
2026-06-05
Last updated
2026-10-30

Condition(s) studied

Pancreatic CancerPancreatic Cancer MetastaticPDACPDAC - Pancreatic Ductal AdenocarcinomaPancreatic Ductal AdenocarcinomaPancreatic Adenocarcinoma MetastaticPancreatic Ductal Adenocarcinoma (PDAC)Pancreatic Adenocarcinoma

Investigational drug(s) / intervention(s)

AtebimetinibGnPmGnP

Atebimetinib: Once daily oral tablets

GnP: Standard of care regimen for intravenous infusions of gemcitabine and nab-paclitaxel weekly for three weeks followed by one week without an infusion

mGnP: Biweekly intravenous infusions of chemotherapy (gemcitabine and nab-paclitaxel)

Study summary

The purpose of this study is to evaluate the safety and efficacy of atebimetinib in combination with modified GnP compared with SOC GnP alone.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Must be ≥18 years of age * Must have confirmed diagnosis according to AJCC staging as follows: * Metastatic pancreatic adenocarcinoma within 12 weeks prior to screening * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Participants must be treatment naive as follows: * First-line PDAC participants will have received no previous systemic anti-cancer therapy * Must have evidence of measurable disease (at least one target lesion) per RECIST v1.1 criteria * Adequate organ function, hepatic function, coagulation studies and protocol determined clinical laboratory values Exclusion Criteria: * Inability to swallow oral medications * Participant has squamous, adenosquamous, neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma * Participants with only locally advanced disease * Symptomatic, untreated, or actively progressing known central nervous system (CNS) metastases

Primary outcome measure(s)

  • Overall Survival — Up to approximately 2 years
    The OS of participants with atebimetinib in combination with mGnP versus GnP

Trial sites (72)

FacilityCityRegionStatus
Clearview Cancer Institute Huntsville Alabama Recruiting
City of Hope Phoenix Arizona Recruiting
City of Hope Duarte California Recruiting
University of California San Diego San Diego California Recruiting
Poudre Valley Health Care, Inc Fort Collins Colorado Recruiting
Rocky Mountain Cancer Centers Lone Tree Colorado Recruiting
Medical Oncology Hematology Consultants Newark Delaware Recruiting
Miami Cancer Institute Miami Florida Recruiting
Hematology Oncology Associates of the Treasure Coast Port Saint Lucie Florida Recruiting
Florida Cancer Specialists - South Sarasota Florida Recruiting
Florida Cancer Specialists - North St. Petersburg Florida Recruiting
Florida Cancer Specialists - East West Palm Beach Florida Recruiting
Piedmont Cancer Institute Atlanta Georgia Recruiting
Piedmont Healthcare Atlanta Georgia Recruiting
Illinois Cancer Specialists Arlington Heights Illinois Recruiting
City of Hope Chicago Illinois Recruiting
OSF Medical Center Peoria Illinois Recruiting
University of Kansas Cancer Center Fairway Kansas Recruiting
Maryland Oncology Columbia Maryland Recruiting
Missouri Cancer Associates Columbia Missouri Recruiting
University of Nebraska Medical Center Omaha Nebraska Recruiting
Comprehensive Cancer Centers Las Vegas Nevada Recruiting
Regional Cancer Care Belleville New Jersey Recruiting
Astera Cancer Care East Brunswick New Jersey Recruiting
NYU Langone Health New York New York Recruiting
Memorial Sloan Kettering Cancer Center New York New York Recruiting
FirstHealth of the Carolinas Pinehurst North Carolina Recruiting
University of Cincinnati Cancer Center Cincinnati Ohio Recruiting
Taylor Cancer Research Center Maumee Ohio Recruiting
Willamette Valley Cancer Institute Eugene Oregon Recruiting
Oregon Health and Science University Portland Oregon Recruiting
Thomas Jefferson University Philadelphia Pennsylvania Recruiting
Prisma Health Greenville South Carolina Recruiting
Avera Cancer Institute Research Sioux Falls South Dakota Recruiting
West Cancer Center Germantown Tennessee Recruiting
Sarah Cannon Research Institute Nashville Tennessee Recruiting
Tennessee Oncology Nashville Tennessee Recruiting
Texas Oncology - West Texas Abilene Texas Recruiting
Texas Oncology - Austin Austin Texas Recruiting
Texas Oncology - San Antonio San Antonio Texas Recruiting

+ 32 more sites — see the full list on the official registry below.

More Immuneering Corporation trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07562152 on ClinicalTrials.gov ↗ ← All trials in the USA