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.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma
Key facts
- Where
- Berlin, Bochum, Bonn, Cologne, Dresden, Düsseldorf, Essen, Frankfurt, Freiburg im Breisgau, Göttingen, Halle, Hamburg, Leipzig, München, Munich, Nuremberg, and Ulm, GermanySee the 19 sites
- Phase
- Phase 3
AI summary: who the study is looking for
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
Read by machine on 9 November 2026.
Could this be for you?
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?
Source: NCT07522073, who can take part
Where in Germany
- BerlinHospital not named in the registryNot yet recruiting
- BerlinHospital not named in the registryTaking people
- BochumHospital not named in the registryTaking people
- BonnHospital not named in the registryNot yet recruiting
- CologneHospital not named in the registryTaking people
- DresdenHospital not named in the registryNot yet recruiting
- DüsseldorfHospital not named in the registryNot yet recruiting
- EssenHospital not named in the registryTaking people
- FrankfurtHospital not named in the registryTaking people
- Freiburg im BreisgauHospital not named in the registryTaking people
- GöttingenHospital not named in the registryNot yet recruiting
- HalleHospital not named in the registryNot yet recruiting
- HamburgHospital not named in the registryTaking people
- HamburgHospital not named in the registryTaking people
- LeipzigHospital not named in the registryNot yet recruiting
- MünchenHospital not named in the registryTaking people
- MunichHospital not named in the registryNot yet recruiting
- NurembergHospital not named in the registryTaking people
- UlmHospital not named in the registryTaking people
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 doctorTrial details
- Who runs it
- Incyte Corporation
- Trial code
- NCT07522073
- Record updated
- 30 October 2026
- Original description
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).Read full original descriptionShow less
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)
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).
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.