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

Sponsor: Incyte Corporation

Sponsor score: 60

ClinicalTrials ID:NCT07522073

This study assesses the efficacy and safety of adding INCB161734 to standard chemotherapy in metastatic PDAC patients with KRAS G12D mutation. Eligible participants must have confirmed metastatic PDAC, no prior systemic treatment, ECOG 0-1, and adequate organ function. Interventions include oral INCB161734 or placebo, alongside investigator-selected chemotherapy.

Patient Parameters

Program 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).

Eligibility Criteria

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.

Locations

FACILITYZIPCITYSTATE
Investigative Site US05835233BirminghamAlabama
Investigative Site US01699508AnchorageAlaska
Investigative Site US02685224ChandlerArizona
Investigative Site US04585719TucsonArizona
Investigative Site US05191010DuarteCalifornia
Investigative Site US04892708Fountain ValleyCalifornia
Investigative Site US04992612IrvineCalifornia
Investigative Site US05492093La JollaCalifornia
Investigative Site US02790027Los AngelesCalifornia
Investigative Site US03690033Los AngelesCalifornia

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