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

ConditionSolid Tumors
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorIncyte Corporation

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • INCB161734
  • Placebo
  • Investigator's choice of chemotherapy

Treatment groups

588 Participants
are divided into 2 treatment groups

Locations

217
Australia
Investigative Site AU00702170, LiverpoolNew South Wales, Australia
Investigative Site AU00302500, WollongongNew South Wales, Australia
Investigative Site AU00605011, Woodville SouthSouth Australia, Australia
Investigative Site AU00103004, MelbourneVictoria, Australia

Sponsors and collaborators

Incyte Corporation

Lead sponsor

Qiagen Manchester Ltd

Collaborator