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Taking people in ItalyPhase 3

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
Bologna, Brescia, Candiolo, Foggia, Milan, Naples, Pisa, Roma, Rome, Rozzano, and Verona, ItalySee the 12 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 Italy

  • BolognaHospital not named in the registryNot yet recruiting
  • BresciaHospital not named in the registryTaking people
  • CandioloHospital not named in the registryTaking people
  • FoggiaHospital not named in the registryNot yet recruiting
  • MilanHospital not named in the registryTaking people
  • MilanHospital not named in the registryNot yet recruiting
  • NaplesHospital not named in the registryNot yet recruiting
  • PisaHospital not named in the registryNot yet recruiting
  • RomaHospital not named in the registryTaking people
  • RomeHospital not named in the registryNot yet recruiting
  • RozzanoHospital not named in the registryTaking people
  • VeronaHospital not named in the registryTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial 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.

ClinicalTrials.gov NCT07522073