Tests a new drug with chemotherapy in pancreatic cancer with a KRAS G12D mutation
Tests adding INCB161734 to chemotherapy in adults with spread pancreatic cancer.
Key facts
- Who runs it
- Incyte Corporation
- Where
- Anderlecht, Brussels, Edegem, Ghent, Gilly, Leuven, Liège, and Yvoir, BelgiumSee the 9 sitesAlso in 21 other countries, 221 sites
- Trial code
- Registry title
- A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 588 people, planned
- Started
- 9 Apr 2026
- Expected to end
- 19 Mar 2029
- Type of study
- Interventional, 2 groups
- Treatments tested
- INCB161734
- Placebo
- Investigator's choice of chemotherapy
- Record updated
- 30 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with pancreatic cancer that has spread to other parts of the body and has a KRAS G12D change. They must not have had drug treatment for the spread yet.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Metastatic pancreatic ductal adenocarcinoma (PDAC), confirmed by tissue or cell tests. ECOG performance status 0-1.
- Earlier treatment
- No earlier drug treatment (systemic treatment) for the cancer once it had spread. No earlier treatment with any KRAS inhibitor.
- Biomarker or test result
- KRAS G12D mutation
Main reasons for not taking part
- Earlier treatment with any KRAS inhibitor
- Ongoing infection needing drug treatment in the week before the first dose of study drug
- Known active cancer spread to the brain or spinal cord (CNS metastases)
- Organs that do not work well enough
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Has a test of your tumor found a change in the KRAS gene called G12D?
- Which describes how well you can do daily activities?
Where in Belgium
Also in 21 other countries, 221 sites
- AnderlechtHospital not named in the registryNot yet recruiting
- BrusselsHospital not named in the registryTaking people
- BrusselsHospital not named in the registryTaking people
- EdegemHospital not named in the registryTaking people
- GhentHospital not named in the registryTaking people
- GillyHospital not named in the registryTaking people
- LeuvenHospital not named in the registryTaking people
- LiègeHospital not named in the registryNot yet recruiting
- YvoirHospital not named in the registryNot yet recruiting
About the trial
What the trial wants to find out
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).
The 2 groups in the trial
- INCB161734 plus chemotherapyTreatment being tested
INCB161734 at the protocol-defined dose with investigator's choice of chemotherapy (mFOLFIRINOX or GemNabP) in accordance with the protocol-defined requirements.
Treatment: INCB161734 and Investigator's choice of chemotherapy
- Placebo plus chemotherapyTreatment being tested
Placebo at the protocol-defined dose with investigator's choice of chemotherapy (mFOLFIRINOX or GemNabP) in accordance with the protocol-defined requirements.
Treatment: Placebo and Investigator's choice of chemotherapy
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official 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)
- Plain-language title
- Tests a new drug with chemotherapy in pancreatic cancer with a KRAS G12D mutationGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07522073, who can take part
- Record updated
- 30 October 2026