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Chemotherapy with or without INCB161734 for untreated KRAS G12D metastatic pancreatic cancer

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)

Phase 3 Interventional Incyte Corporation · NCT07522073

This will test whether adding the KRAS G12D blocker INCB161734 to standard chemotherapy helps people with newly diagnosed metastatic pancreatic cancer that has a KRAS G12D mutation.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment588 (estimated)
Ages18 Years and up
SexAll
SponsorIncyte Corporation Industry-sponsored
Drugs / interventionschemotherapy
Locations212 sites (Birmingham, Alabama and 211 other locations)
Trial IDNCT07522073 on ClinicalTrials.gov

What this trial studies

This randomized phase 3 study compares standard investigator‑choice chemotherapy given with either the oral KRAS G12D inhibitor INCB161734 or matching placebo in participants with metastatic pancreatic ductal adenocarcinoma harboring a KRAS G12D mutation. Eligible patients must be systemic treatment–naïve in the metastatic setting, have ECOG performance status 0–1, and meet organ function requirements. Participants are assigned to one of the two arms and followed for safety, tumor response, and survival outcomes. The protocol excludes prior KRAS inhibitor exposure and active central nervous system metastases.

Who should consider this trial

Good fit: Ideal candidates are people with histologically confirmed metastatic pancreatic ductal adenocarcinoma carrying a KRAS G12D mutation who have not received prior systemic therapy for metastatic disease, have ECOG 0–1, and adequate organ function.

Not a fit: Patients without a KRAS G12D mutation, those previously treated with a KRAS inhibitor, people with active CNS metastases, uncontrolled infection, or poor performance status are unlikely to be eligible or to benefit from this approach.

Why it matters

Potential benefit: If successful, adding INCB161734 to chemotherapy could improve tumor control and extend survival for people with KRAS G12D‑mutated metastatic pancreatic cancer.

How similar studies have performed: Targeting KRAS G12D is a relatively new and promising approach but has limited clinical evidence so far and no definitive phase 3 successes for KRAS G12D inhibitors have been published.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Birmingham, Alabama and 211 other locations

+162 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Solid TumorsINCB161734KRASG12D Mutationpancreatic ductal adenocarcinomaKRAS G12D inhibitorKRAS inhibitorKRAS mutationpancreatic cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.