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

A Randomized, Double-Blind, Phase 3 Study of Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma (DAWN-303)

Who can join

Ages 18 and older · All sexes

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.

About the study

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).

What is being tested

• INCB161734 (drug)
• Placebo (drug)
• Investigator's choice of chemotherapy (drug)

Sponsor: Incyte Corporation · Participants: 588 · Started: Apr 9, 2026

Contact the study team

• Incyte Corporation Call Center (US) · Phone: 1.855.463.3463
• Incyte Corporation Call Center (ex-US) · Phone: +800 00027423

Official record on ClinicalTrials.gov — NCT07522073

Locations in the U.S.

Conditions

• Pancreatic Cancer

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.