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Clinical Trials List

Protocol NumberIMM1104-301

NCT Number(ClinicalTrials.gov Identfier)NCT07562152

Not yet recruiting

2026-09-01 - 2029-03-31

Phase III

Not yet recruiting4

A Phase 3, randomized, open-label study (MAPKeeper 301) comparing atebimetinib combined with a modified gemcitabine and nab-paclitaxel regimen versus the standard gemcitabine and nab-paclitaxel regimen for the treatment of patients with metastatic pancreatic ductal adenocarcinoma.

Trial Applicant

WORLDWIDE CLINICAL TRIALS (TAIWAN) CO., LTD.
Sponsor

WorldWide Clinical Trials(Taiwan) Co., LTD.
Trial scale

Multi-Regional Multi-Center
Update

2026/09/30

Investigators and Locations

Principal Investigator Li-Yuan Bai 無

China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator SHAO-CIAO LUO 無

Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Chung-Pin Li 無

Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Wen-Chi Chou

Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Condition/Disease

Metastatic pancreatic adenocarcinoma

Objectives

Atebimetinib is a drug designed to achieve profound and sustained MEK inhibition; it offers improved tolerability and the ability to prevent the rapid rebound of RAF-mediated pathway signaling, thereby providing a novel therapeutic approach for patients with MAPK-driven tumors. This trial aims to evaluate its potential to address a significant unmet medical need in the treatment of metastatic pancreatic adenocarcinoma. Primary Objective: To evaluate the overall survival (OS) associated with atebimetinib in combination with modified gemcitabine plus nab-paclitaxel (mGnP) versus gemcitabine plus nab-paclitaxel in patients with previously untreated metastatic pancreatic adenocarcinoma.

Test Drug

Atebimetinib

Active Ingredient

IMM-1-104

Dosage Form

TABLETS

Dosage

120 mg/ 160 mg

Endpoints

Time from randomization to the date of death (any cause).

Inclution Criteria

This trial will enroll adult participants (≥18 years of age) with a new diagnosis of metastatic pancreatic adenocarcinoma (AJCC 8th edition criteria), an ECOG performance status score of 0–1, and at least one measurable metastatic lesion per RECIST version 1.1 at screening.

Exclusion Criteria

Participants with squamous cell carcinoma, adenosquamous carcinoma, neuroendocrine carcinoma, or acinar cell carcinoma of the pancreas; those who have previously received systemic therapy, radiotherapy, surgery, or experimental treatment for metastatic pancreatic cancer; and those who have received adjuvant chemotherapy or have unresolved treatment-related toxicities within 6 months prior to screening will be excluded.

The Estimated Number of Participants

Taiwan

40 participants
Global

510 participants