RecruitingPhase 3NCT07522073

A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma

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)

Sponsor

Incyte Corporation

Enrollment

588 participants

Start Date

Apr 9, 2026

Study Type

INTERVENTIONAL

Conditions

Solid Tumors

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called INCB161734, a drug called Investigator's choice of chemotherapy, and others for people with solid tumors. The study is currently recruiting participants at 218 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGINCB161734

Oral; tablet

DRUGPlacebo

Oral; tablet

DRUGInvestigator'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(215)

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 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 US041

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 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 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 US081

Olympia, Washington, 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 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 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 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 JP010

Kahoku-gun, Japan

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

Utrecht, 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 ES002

Barcelona, Spain

Investigative Site ES003

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

Lund, 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

View Full Details on ClinicalTrials.gov

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NCT07522073

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