Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
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)
Immuneering Corporation
510 participants
Jun 1, 2026
INTERVENTIONAL
Conditions
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
Inclusion Criteria8
- 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 Criteria4
- 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
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Interventions
Once daily oral tablets
Standard of care regimen for intravenous infusions of gemcitabine and nab-paclitaxel weekly for three weeks followed by one week without an infusion
Biweekly intravenous infusions of chemotherapy (gemcitabine and nab-paclitaxel)
Locations(16)
View Full Details on ClinicalTrials.gov
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NCT07562152