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A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma
Sponsor: Incyte Corporation
Summary
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).
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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
588
Start Date
2026-04-09
Completion Date
2029-03-19
Last Updated
2026-10-30
Healthy Volunteers
No
Conditions
Interventions
INCB161734
Oral; tablet
Placebo
Oral; tablet
Investigator's choice of chemotherapy
The investigator will select the chemotherapy in accordance with the protocol-defined requirements. The possible choices as defined by the protocol:
Locations (230)
Investigative Site US058
Birmingham, Alabama, United States
Investigative Site US016
Anchorage, Alaska, United States
Investigative Site US026
Chandler, Arizona, United States
Investigative Site US045
Tucson, Arizona, United States
Investigative Site US051
Duarte, California, United States
Investigative Site US085
Fullerton, California, United States
Investigative Site US054
La Jolla, California, United States
Investigative Site US086
Long Beach, California, United States
Investigative Site US027
Los Angeles, California, United States
Investigative Site US036
Los Angeles, California, United States
Investigative Site US048
Los Angeles, California, United States
Investigative Site US049
Orange, California, United States
Investigative Site US034
San Francisco, California, United States
Investigative Site US001
Santa Monica, California, United States
Investigative Site US071
Denver, Colorado, United States
Investigative Site US013
Washington D.C., District of Columbia, United States
Investigative Site US046
Washington D.C., District of Columbia, United States
Investigative Site US072
Fort Myers, Florida, United States
Investigative Site US083
Jacksonville, Florida, United States
Investigative Site US075
Miami, Florida, United States
Investigative Site US074
St. Petersburg, Florida, United States
Investigative Site US073
West Palm Beach, Florida, United States
Investigative Site US023
Atlanta, Georgia, United States
Investigative Site US079
Chicago, Illinois, United States
Investigative Site US030
Evanston, Illinois, United States
Investigative Site US005
Naperville, Illinois, United States
Investigative Site US009
Springfield, Illinois, United States
Investigative Site US021
Indianapolis, Indiana, United States
Investigative Site US007
New Orleans, Louisiana, United States
Investigative Site US022
Boston, Massachusetts, United States
Investigative Site US006
Ann Arbor, Michigan, United States
Investigative Site US010
Detroit, Michigan, United States
Investigative Site US078
Grand Rapids, Michigan, United States
Investigative Site US012
Ypsilanti, Michigan, United States
Investigative Site US066
Maple Grove, Minnesota, United States
Investigative Site US047
Hattiesburg, Mississippi, United States
Investigative Site US084
Reno, Nevada, United States
Investigative Site US077
Hackensack, New Jersey, United States
Investigative Site US017
Morristown, New Jersey, United States
Investigative Site US059
Lake Success, New York, United States
Investigative Site US031
New York, New York, United States
Investigative Site US003
New York, New York, United States
Investigative Site US041
New York, New York, United States
Investigative Site US029
The Bronx, New York, United States
Investigative Site US035
Chapel Hill, North Carolina, United States
Investigative Site US050
Cleveland, Ohio, United States
Investigative Site US020
Cleveland, Ohio, United States
Investigative Site US033
Columbus, Ohio, United States
Investigative Site US042
Portland, Oregon, United States
Investigative Site US008
Philadelphia, Pennsylvania, United States
Investigative Site US043
Philadelphia, Pennsylvania, United States
Investigative Site US056
Pittsburgh, Pennsylvania, United States
Investigative Site US082
Charleston, South Carolina, United States
Investigative Site US055
Sioux Falls, South Dakota, United States
Investigative Site US039
Nashville, Tennessee, United States
Investigative Site US060
Nashville, Tennessee, United States
Investigative Site US070
Nashville, Tennessee, United States
Investigative Site US067
Dallas, Texas, United States
Investigative Site US062
Denison, Texas, United States
Investigative Site US011
Houston, Texas, United States
Investigative Site US080
San Antonio, Texas, United States
Investigative Site US063
San Antonio, Texas, United States
Investigative Site US053
Salt Lake City, Utah, United States
Investigative Site US057
Fairfax, Virginia, United States
Investigative Site US065
Fairfax, Virginia, United States
Investigative Site US064
Salem, Virginia, United States
Investigative Site US081
Olympia, Washington, United States
Investigative Site US032
Seattle, Washington, United States
Investigative Site US044
Madison, Wisconsin, United States
Investigative Site AU011
Macquarie Park, New South Wales, Australia
Investigative Site AU010
Chermside, Queensland, Australia
Investigative Site AU009
Townsville, Queensland, Australia
Investigative Site AU006
Woodville South, South Australia, Australia
Investigative Site AU004
Melbourne, Victoria, Australia
Investigative Site AU001
Melbourne, Victoria, Australia
Investigative Site AU005
Richmond, Victoria, Australia
Investigative Site AU002
Canberra, Australia
Investigative Site AU008
Perth, Australia
Investigative Site AT005
Graz, Austria
Investigative Site AT002
Innsbruck, Austria
Investigative Site AT004
Linz, Austria
Investigative Site AT003
Salzburg, Austria
Investigative Site BE008
Anderlecht, Belgium
Investigative Site BE003
Brussels, Belgium
Investigative Site BE009
Brussels, Belgium
Investigative Site BE001
Edegem, Belgium
Investigative Site BE005
Ghent, Belgium
Investigative Site BE007
Gilly, Belgium
Investigative Site BE004
Leuven, Belgium
Investigative Site BE006
Liège, Belgium
Investigative Site BE002
Yvoir, Belgium
Investigative Site CA007
Hamilton, Ontario, Canada
Investigative Site CA008
Kingston, Ontario, Canada
Investigative Site CA001
Toronto, Ontario, Canada
Investigative Site CA006
Montreal, Quebec, Canada
Investigative Site CA004
Québec, Quebec, Canada
Investigative Site DK006
Aalborg, Denmark
Investigative Site DK005
Århus N, Denmark
Investigative Site DK001
Herlev, Denmark
Investigative Site DK003
Køge, Denmark