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RecruitingLast updated: 14 August 2026

DAWN-303: Testing whether adding a targeted therapy to standard chemotherapy is safe and effective for people with metastatic pancreatic cancer with a KRAS G12D mutation.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)

Trial purpose

Medical clipboardCancer treatment

Tumor type

Upper gastrointestinal tract Cancers Upper gastrointestinal tract

Age

People18+

Trial acronym

DAWN-303

Clinical summary

Summary

TThis study is looking at whether adding a targeted drug called INCB161734 to standard chemotherapy is safe and works better than standard chemotherapy alone for people with metastatic pancreatic cancer that has a KRAS G12D mutation.

Who can take part?
You may be eligible for this study if:

  • you have pancreatic ductal adenocarcinoma (PDAC)
  • your cancer has spread to other parts of the body (metastatic)
  • your cancer has a KRAS G12D mutation
  • you have not received drug treatment for your metastatic cancer before.

If you received treatment when your cancer was at an earlier stage, you may still be eligible. Speak with your doctor or the study team to find out.

What does participation involve?
If you join this study, you will be randomly assigned (by chance) to one of two treatment groups:

  • INCB161734 plus standard chemotherapy
  • Placebo plus standard chemotherapy
The study drug or placebo is taken as a tablet. The chemotherapy treatment you receive will be decided by your doctor and will be either mFOLFIRINOX or GemNabP (gemcitabine and nab-paclitaxel).

Conditions

This trial is treating people with previously untreated, metastatic pancreatic ductal adenocarcinoma

Eligibility

Inclusion

  • 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

  • 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.

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Incyte Corporation

Scientific Title

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)

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