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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
2026-05-08
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 (212)
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 US048
Fountain Valley, California, United States
Investigative Site US049
Irvine, California, United States
Investigative Site US054
La Jolla, California, United States
Investigative Site US027
Los Angeles, California, United States
Investigative Site US036
Los Angeles, 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 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 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 US041
New York, New York, United States
Investigative Site US004
New York, New York, United States
Investigative Site US003
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 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 US018
Houston, Texas, United States
Investigative Site US063
San Antonio, Texas, United States
Investigative Site US053
Salt Lake City, Utah, United States
Investigative Site US076
Charlottesville, Virginia, 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 US032
Seattle, Washington, United States
Investigative Site US044
Madison, Wisconsin, United States
Investigative Site AU007
Liverpool, New South Wales, Australia
Investigative Site AU003
Wollongong, New South Wales, Australia
Investigative Site AU006
Woodville South, South Australia, Australia
Investigative Site AU005
Box Hill, Victoria, Australia
Investigative Site AU004
Melbourne, Victoria, Australia
Investigative Site AU001
Melbourne, Victoria, Australia
Investigative Site AU002
Canberra, Australia
Investigative Site AU008
Perth, Australia
Investigative Site AT002
Innsbruck, Austria
Investigative Site AT004
Linz, Austria
Investigative Site AT003
Salzburg, Austria
Investigative Site AT001
Vienna, 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 CA001
Toronto, Ontario, Canada
Investigative Site CA005
Laval, Quebec, 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 DK004
Odense C, Denmark
Investigative Site DK003
Roskilde, Denmark
Investigative Site DK002
Vejle, Denmark
Investigative Site FI001
Helsinki, Finland
Investigative Site FI003
Tampere, Finland
Investigative Site FI002
Turku, Finland
Investigative Site FR013
Brest, France
Investigative Site FR012
Chambray-lès-Tours, France
Investigative Site FR014
Dijon, France
Investigative Site FR002
Lille, France
Investigative Site FR011
Lyon, France
Investigative Site FR016
Lyon, France
Investigative Site FR006
Marseille, France
Investigative Site FR015
Montpellier, France
Investigative Site FR003
Paris, France
Investigative Site FR009
Paris, France
Investigative Site FR004
Pessac, France
Investigative Site FR008
Poitiers, France
Investigative Site FR010
Reims, France
Investigative Site FR005
Rennes, France
Investigative Site FR007
Toulouse, France
Investigative Site FR001
Villejuif, France
Investigative Site DE018
Berlin, Germany
Investigative Site DE020
Berlin, Germany
Investigative Site DE003
Bochum, Germany
Investigative Site DE019
Bonn, Germany
Investigative Site DE008
Cologne, Germany
Investigative Site DE001
Dresden, Germany
Investigative Site DE013
Düsseldorf, Germany
Investigative Site DE004
Essen, Germany
Investigative Site DE005
Frankfurt, Germany
Investigative Site DE016
Freiburg im Breisgau, Germany
Investigative Site DE017
Göttingen, Germany
Investigative Site DE002
Halle, Germany
Investigative Site DE007
Hamburg, Germany
Investigative Site DE006
Hamburg, Germany
Investigative Site DE009
Leipzig, Germany
Investigative Site DE015
Munich, Germany
Investigative Site DE014
München, Germany
Investigative Site DE010
Nuremberg, Germany
Investigative Site DE011
Ulm, Germany
Investigative Site IT002
Bologna, Italy
Investigative Site IT010
Brescia, Italy
Investigative Site IT009
Candiolo, Italy
Investigative Site IT012
Foggia, Italy
Investigative Site IT006
Milan, Italy
Investigative Site IT008
Milan, Italy
Investigative Site IT011
Naples, Italy
Investigative Site IT003
Pisa, Italy
Investigative Site IT004
Roma, Italy
Investigative Site IT005
Rome, Italy
Investigative Site IT001
Rozzano, Italy
Investigative Site IT007
Verona, Italy
Investigative Site JP002
Kashiwa-shi, Japan
Investigative Site JP003
Kōtoku, Japan
Investigative Site JP007
Mitaka-shi, Japan
Investigative Site JP004
Osaka, Japan
Investigative Site JP009
Shinjuku-ku, Japan
Investigative Site JP006
Toyama, Japan
Investigative Site JP008
Wakayama, Japan
Investigative Site JP001
Yokohama, Japan
Investigative Site NL001
Amsterdam, Netherlands
Investigative Site NL007
Eindhoven, Netherlands
Investigative Site NL005
Groningen, Netherlands
Investigative Site NL003
Maastricht, Netherlands
Investigative Site NL006
Nieuwegein, Netherlands
Investigative Site NO002
Bergen, Norway
Investigative Site NO001
Oslo, Norway
Investigative Site NO005
Stavanger, Norway
Investigative Site NO003
Trondheim, Norway
Investigative Site PL008
Gdansk, Poland
Investigative Site PL003
Krakow, Poland
Investigative Site PL007
Warsaw, Poland
Investigative Site PL001
Warsaw, Poland
Investigative Site PL002
Warsaw, Poland
Investigative Site PL004
Wroclaw, Poland
Investigative Site PR001
Dorado, Puerto Rico
Investigative Site KR004
Goyang-si, South Korea
Investigative Site KR005
Seongnam, South Korea
Investigative Site KR007
Seongnam-si, South Korea
Investigative Site KR002
Seoul, South Korea
Investigative Site KR006
Seoul, South Korea
Investigative Site KR001
Seoul, South Korea
Investigative Site KR003
Seoul, South Korea
Investigative Site KR008
Seoul, South Korea
Investigative Site ES011
Badalona, Spain
Investigative Site ES003
Barcelona, Spain
Investigative Site ES002
Barcelona, Spain
Investigative Site ES014
Las Palmas de Gran Canaria, Spain
Investigative Site ES016
Madrid, Spain
Investigative Site ES006
Madrid, Spain
Investigative Site ES007
Madrid, Spain
Investigative Site ES012
Madrid, Spain
Investigative Site ES008
Madrid, Spain
Investigative Site ES013
Madrid, Spain
Investigative Site ES005
Palma de Mallorca, Spain
Investigative Site ES009
Santander, Spain
Investigative Site ES010
Seville, Spain
Investigative Site ES015
Valencia, Spain
Investigative Site ES017
Valencia, Spain
Investigative Site ES001
Valencia, Spain
Investigative Site ES004
Zaragoza, Spain
Investigative Site SE003
Linköping, Sweden
Investigative Site SE001
Malmö, Sweden
Investigative Site SE002
Solna, Sweden
Investigative Site CH005
Basel, Switzerland
Investigative Site CH003
Bern, Switzerland
Investigative Site CH004
Geneva, Switzerland
Investigative Site CH002
Lausanne, Switzerland
Investigative Site CH001
Zurich, Switzerland
Investigative Site GB008
Dundee, United Kingdom
Investigative Site GB011
Guildford, United Kingdom
Investigative Site GB002
Headington, United Kingdom
Investigative Site GB001
Leeds, United Kingdom
Investigative Site GB009
London, United Kingdom
Investigative Site GB004
London, United Kingdom
Investigative Site GB003
Manchester, United Kingdom
Investigative Site GB010
Northwood, United Kingdom
Investigative Site GB005
Norwich, United Kingdom