NCT07562152

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
510

participants targeted

Target at P75+ for phase_3 pancreatic-cancer

Timeline
34mo left

Started May 2026

Shorter than P25 for phase_3 pancreatic-cancer

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
May 2026Feb 2029

First Submitted

Initial submission to the registry

April 20, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 1, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2029

Last Updated

May 6, 2026

Status Verified

May 1, 2026

Enrollment Period

2.1 years

First QC Date

April 20, 2026

Last Update Submit

May 5, 2026

Conditions

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

Keywords

mitogen-activated protein kinase (MAPK)MAPKMEKmetastatic cancergemcitabinenab-paclitaxelnab-patebimetinib

Outcome Measures

Primary Outcomes (1)

  • Overall Survival

    The OS of participants with atebimetinib in combination with mGnP versus GnP

    Up to approximately 2 years

Secondary Outcomes (5)

  • Progression Free Survival (PFS)

    Up to approximately 2 years

  • Overall Response Rate (ORR)

    Up to approximately 2 years

  • Disease Control Rate (DCR)

    Up to approximately 2 years

  • Incidence of Adverse Events (AEs)

    Up to approximately 2 years

  • Quality of Life (QOL) with European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)

    Up to approximately 2 years

Study Arms (2)

Atebimetinib + mGnP

EXPERIMENTAL

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

Drug: AtebimetinibDrug: mGnP

GnP

ACTIVE COMPARATOR

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

Drug: GnP

Interventions

AtebimetinibDRUG

Once daily oral tablets

Atebimetinib + mGnP
GnPDRUG

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

GnP
mGnPDRUG

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

Atebimetinib + mGnP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must be ≥18 years of age
  • Must have confirmed diagnosis according to AJCC staging as follows:
  • Metastatic pancreatic adenocarcinoma at least 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

City of Hope

Phoenix, Arizona, 85338, United States

RECRUITING

City of Hope

Duarte, California, 91010, United States

RECRUITING

City of Hope

Chicago, Illinois, 60099, United States

RECRUITING

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

Taylor Cancer Research Center

Maumee, Ohio, 43537, United States

RECRUITING

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

RECRUITING

MeSH Terms

Conditions

Pancreatic NeoplasmsNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Immuneering Study Team

CONTACT

860-321-1302clinicaltrials@immuneering.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2026

First Posted

May 1, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

February 1, 2029

Last Updated

May 6, 2026

Record last verified: 2026-05

Locations

US(6)