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

ClinicalTrials.gov ID

NCT07562152

Lead Sponsor

Immuneering CorporationINDUSTRY

Overall Status

Recruiting

Study Type

Interventional

Phase

Phase 3

Enrollment

510Estimated

Last Update Posted

Sep 11, 2026Actual

Start Date

Jun 5, 2026Actual

Primary Completion Date

Jun 2028Estimated

Completion Date

Feb 2029Estimated

Official Title

A Phase 3 Randomized, Open-Label Study of Atebimetinib in Combination With the Modified Gemcitabine and Nab-Paclitaxel Regimen Versus the Standard Gemcitabine and Nab-Paclitaxel Regimen for the Treatment of Patients With Metastatic Pancreatic Ductal Pancreatic Adenocarcinoma Cancer (MAPKeeper 301)

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.

Detailed Description

This is a global, randomized, open-label, Phase 3 study designed to evaluate whether treatment with atebimetinib plus a modified schedule of gemcitabine and nab-paclitaxel will improve overall survival compared with standard gemcitabine and nab-paclitaxel when given as first-line treatment in patients with metastatic pancreatic adenocarcinoma.

Patients will be randomized to one of two arms: Arm A with atebimetinib + gemcitabine and nab-paclitaxel (modified dosing schedule) or Arm B with gemcitabine and nab-paclitaxel.

• Pancreatic Cancer
• Pancreatic Cancer Metastatic
• PDAC
• PDAC - Pancreatic Ductal Adenocarcinoma
• Pancreatic Ductal Adenocarcinoma
• Pancreatic Adenocarcinoma Metastatic
• Pancreatic Ductal Adenocarcinoma (PDAC)
• Pancreatic Adenocarcinoma

• Atebimetinib
• GnP
• mGnP

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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 Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Immuneering CorporationINDUSTRY

phxresearch@coh.org

jtangen@coh.org

KAdams@piedmontcancerinstitute.com

ORRTeam@piedmont.org

jtangen@coh.org

peyton.o.swearingen@osfhealthcare.org

corilynn.hughes@usoncology.com

ct.gov@nyulangone.org

rpatterson@westclinic.com

cpecknold@tnonc.com

marian.heaven@usoncology.com

tara.gray@usoncology.com

kim.bloomfield@genesicare.com.au+61 02 4632 5500

sallyheath@phcn.vic.gov.au

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