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

Sponsor: Immuneering Corporation

Sponsor score: 0

ClinicalTrials ID:NCT07562152

This Phase 3 study assesses the safety and efficacy of atebimetinib with modified gemcitabine and nab-paclitaxel (mGnP) versus standard GnP in metastatic pancreatic adenocarcinoma. Eligible patients are ≥18, treatment-naive, with confirmed metastatic disease and ECOG 0-1. Interventions include oral atebimetinib and biweekly mGnP or standard GnP.

Patient Parameters

Program Overview

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

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.

Eligibility Criteria

Inclusion Criteria

  • 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

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

Locations

FACILITYZIPCITYSTATE
City of Hope85338PhoenixArizona
City of Hope91010DuarteCalifornia
Piedmont Healthcare30318AtlantaGeorgia
City of Hope60099ChicagoIllinois
Missouri Cancer Associates65201ColumbiaMissouri
Comprehensive Cancer Centers89169Las VegasNevada
Regional Cancer Care07109BellevilleNew Jersey
NYU Langone Health10016New YorkNew York
Taylor Cancer Research Center43537MaumeeOhio
Sarah Cannon Research Institute37203NashvilleTennessee

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