Gastrointestinal Cancers

A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma

National Clinical Trial ID:: NCT07522073(opens in a new tab)
Protocol ID:: VICCGI26024
Primary Investigator:: Dana Cardin
Phase:: III
Age Group:: Adults
Genders Eligible:: All
Drug:: Fluorouracil (5-FU), Folinic Acid, Gemcitabine, INCB161734, Irinotecan, Leucovorin, Nab-Paclitaxel, Oxaliplatin
Cancer Type:: Gastrointestinal Cancers

Overview

The purpose of this study is to evaluate the efficacy and safety of standard chemotherapy with or without INCB161734 in participants with metastatic pancreatic ductal adenocarcinoma (PDAC).

Who Can Participate

Inclusion Criteria

Histologically or cytologically confirmed metastatic PDAC with a KRAS G12D mutation

No prior systemic treatment in the metastatic setting

ECOG Performance status 0-1

Adequate organ function

Exclusion Criteria

Prior treatment with any KRAS inhibitor

Chronic or current active infection requiring systemic treatment within 1 week prior to the first dose of study drug

Known active CNS metastases

Other protocol-defined Inclusion/Exclusion Criteria may apply.

Disclaimer

This summary is based on publicly available information from clinicaltrials.gov and is intended to help patients discuss possible trial options with their oncology care team. ClinicalTrials.gov and related public listings do not independently review or approve the safety and scientific merit of every study.

Participation decisions can be made only after review by the study team and your treating clinician.