Recruiting
Phase 3

Atebimetinib & Modified GnP

Sponsor:

Immuneering Corporation

Code:

NCT07562152

Conditions

Pancreatic Cancer

Pancreatic Cancer Metastatic

PDAC

PDAC - Pancreatic Ductal Adenocarcinoma

Pancreatic Ductal Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Atebimetinib

GnP

mGnP

Study Details

Brief 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.

Conditions

Pancreatic Cancer

Pancreatic Cancer Metastatic

PDAC

PDAC - Pancreatic Ductal Adenocarcinoma

Pancreatic Ductal Adenocarcinoma

Study ID

NCT07562152

Start date

Jun 5, 2026

Status verified date

Oct, 2026

Completion date

Feb, 2029

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

510 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Atebimetinib + mGnP

Atebimetinib in combination with modified gemcitabine and nab-paclitaxel for first line pancreatic adenocarcinoma

active comparator: GnP

Standard of care gemcitabine and nab-paclitaxel for first line pancreatic adenocarcinoma

Interventions

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)

Primary outcome measure

  • Overall Survival [ Time Frame: Up to approximately 2 years ]

Central Contacts and Locations

Central contacts

Locations

Clearview Cancer Institute

Recruiting

Huntsville, Alabama, United States, 35805

City of Hope

Recruiting

Phoenix, Arizona, United States, 85338

Contacts

City of Hope

Recruiting

Duarte, California, United States, 91010

Contacts

Jalene Tangen

jtangen@coh.org

University of California San Diego

Recruiting

San Diego, California, United States, 92037

Poudre Valley Health Care, Inc

Recruiting

Fort Collins, Colorado, United States, 80528

Contacts

Rocky Mountain Cancer Centers

Recruiting

Lone Tree, Colorado, United States, 80124

Contacts

Medical Oncology Hematology Consultants

Recruiting

Newark, Delaware, United States, 19713

Contacts

Hematology Oncology Associates of the Treasure Coast

Recruiting

Port Saint Lucie, Florida, United States, 34952

Contacts

Christine Gerdes

cgerdes@hemoncfl.com

Florida Cancer Specialists - South

Recruiting

Sarasota, Florida, United States, 34239

Contacts

Florida Cancer Specialists - North

Recruiting

St. Petersburg, Florida, United States, 33701

Contacts

Florida Cancer Specialists - East

Recruiting

West Palm Beach, Florida, United States, 33401

Contacts

Piedmont Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30318

Contacts

Piedmont Healthcare

Recruiting

Atlanta, Georgia, United States, 30318

Contacts

Illinois Cancer Specialists

Recruiting

Arlington Heights, Illinois, United States, 60005

Contacts

City of Hope

Recruiting

Chicago, Illinois, United States, 60099

Contacts

Jalene Tangen

jtangen@coh.org

OSF Medical Center

Recruiting

Peoria, Illinois, United States, 61603

Contacts

University of Kansas Cancer Center

Recruiting

Fairway, Kansas, United States, 66205

Contacts

Maryland Oncology

Recruiting

Columbia, Maryland, United States, 21044

Contacts

Missouri Cancer Associates

Recruiting

Columbia, Missouri, United States, 65201

Contacts

Comprehensive Cancer Centers

Recruiting

Las Vegas, Nevada, United States, 89169

Contacts

Regional Cancer Care

Recruiting

Belleville, New Jersey, United States, 07109

Contacts

Astera Cancer Care

Recruiting

East Brunswick, New Jersey, United States, 08816

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Contacts

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

FirstHealth of the Carolinas

Recruiting

Pinehurst, North Carolina, United States, 28374

Contacts

University of Cincinnati Cancer Center

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

Taylor Cancer Research Center

Recruiting

Maumee, Ohio, United States, 43537

Contacts

Stephanie Ambrose

sambrose@tcrcpt.org

Willamette Valley Cancer Institute

Recruiting

Eugene, Oregon, United States, 97401

Contacts

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97201

Contacts

Study Team

trials@ohsu.edu

Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Prisma Health

Recruiting

Greenville, South Carolina, United States, 29605

Avera Cancer Institute Research

Recruiting

Sioux Falls, South Dakota, United States, 57105

Contacts

Study Coordinator

MedOncResearch@avera.org

West Cancer Center

Recruiting

Germantown, Tennessee, United States, 38138

Contacts

Sarah Cannon Research Institute

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Tennessee Oncology

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Catt Pecknold

cpecknold@tnonc.com

Texas Oncology - West Texas

Recruiting

Abilene, Texas, United States, 79606

Contacts

Texas Oncology - Austin

Recruiting

Austin, Texas, United States, 78705

Contacts

Texas Oncology - San Antonio

Recruiting

San Antonio, Texas, United States, 78240

Contacts

Texas Oncology Gulf Coast

Recruiting

Webster, Texas, United States, 77598

Contacts

Blue Ridge Cancer Care

Recruiting

Blacksburg, Virginia, United States, 24060

Contacts

Virginia Cancer Specialists

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

University of Washington Fred Hutchinson Cancer Center

Recruiting

Seattle, Washington, United States, 98109

Contacts

Northwest Cancer Specialists

Recruiting

Vancouver, Washington, United States, 98684

Contacts

University of Wisconsin Carbone Cancer Center

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

More Information

Sponsor

Immuneering Corporation

Last update posted

Oct 5, 2026

Last verified

Oct, 2026

Keywords

  • mitogen-activated protein kinase (MAPK)
  • MAPK
  • MEK
  • metastatic cancer
  • gemcitabine
  • nab-paclitaxel
  • nab-p
  • atebimetinib
  • KRAS
  • pan-RAS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-08. This information was provided to ClinicalTrials.gov by Immuneering Corporation on 2026-10-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.