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NCT07522073PHASE3Recruiting

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

Incyte Corporation

Start Date

4/9/2026

Completion Date

3/19/2029

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 Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * 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 Criteria: * 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.

Interventions

DRUG

INCB161734

DRUG

Placebo

DRUG

Investigator's choice of chemotherapy

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Conditions

Solid Tumors

Locations

Investigative Site US058

Birmingham, Alabama 35233

United States

Investigative Site US016

Anchorage, Alaska 99508

United States

Investigative Site US026

Chandler, Arizona 85224

United States

Investigative Site US045

Tucson, Arizona 85719

United States

Investigative Site US051

Duarte, California 91010

United States

Investigative Site US048

Fountain Valley, California 92708

United States

Investigative Site US049

Irvine, California 92612

United States

Investigative Site US054

La Jolla, California 92093

United States

Investigative Site US027

Los Angeles, California 90027

United States

Investigative Site US036

Los Angeles, California 90089

United States

Investigative Site US034

San Francisco, California 94143

United States

Investigative Site US001

Santa Monica, California 90404

United States

Investigative Site US071

Denver, Colorado 80218

United States

Investigative Site US013

Washington D.C., District of Columbia 20007

United States

Investigative Site US046

Washington D.C., District of Columbia 20016

United States

Investigative Site US072

Fort Myers, Florida 33901

United States

Investigative Site US083

Jacksonville, Florida 32207

United States

Investigative Site US075

Miami, Florida 33136

United States

Investigative Site US074

St. Petersburg, Florida 33701-4553

United States

Investigative Site US073

West Palm Beach, Florida 33401

United States

Investigative Site US023

Atlanta, Georgia 30322

United States

Investigative Site US079

Chicago, Illinois 60637

United States

Investigative Site US030

Evanston, Illinois 60201

United States

Investigative Site US005

Naperville, Illinois 60540

United States

Investigative Site US009

Springfield, Illinois 62702

United States

Investigative Site US021

Indianapolis, Indiana 46250

United States

Investigative Site US007

New Orleans, Louisiana 70121

United States

Investigative Site US022

Boston, Massachusetts 02215

United States

Investigative Site US006

Ann Arbor, Michigan 48109

United States

Investigative Site US010

Detroit, Michigan 48201

United States

Investigative Site US078

Grand Rapids, Michigan 49503

United States

Investigative Site US012

Ypsilanti, Michigan 48197

United States

Investigative Site US066

Maple Grove, Minnesota 55369

United States

Investigative Site US047

Hattiesburg, Mississippi 39401

United States

Investigative Site US084

Reno, Nevada 89502

United States

Investigative Site US077

Hackensack, New Jersey 07601

United States

Investigative Site US017

Morristown, New Jersey 07960

United States

Investigative Site US059

Lake Success, New York 11042

United States

Investigative Site US031

New York, New York 10016

United States

Investigative Site US041

New York, New York 10029

United States

Investigative Site US003

New York, New York 10065

United States

Investigative Site US029

The Bronx, New York 10461

United States

Investigative Site US035

Chapel Hill, North Carolina 27514

United States

Investigative Site US050

Cleveland, Ohio 44106

United States

Investigative Site US020

Cleveland, Ohio 44195

United States

Investigative Site US033

Columbus, Ohio 43210

United States

Investigative Site US042

Portland, Oregon 97239

United States

Investigative Site US008

Philadelphia, Pennsylvania 19104

United States

Investigative Site US043

Philadelphia, Pennsylvania 19107

United States

Investigative Site US056

Pittsburgh, Pennsylvania 15212

United States

Investigative Site US082

Charleston, South Carolina 29425

United States

Investigative Site US055

Sioux Falls, South Dakota 57105

United States

Investigative Site US039

Nashville, Tennessee 37203

United States

Investigative Site US060

Nashville, Tennessee 37203

United States

Investigative Site US070

Nashville, Tennessee 37232

United States

Investigative Site US067

Dallas, Texas 75246

United States

Investigative Site US062

Denison, Texas 75020

United States

Investigative Site US011

Houston, Texas 77030

United States

Investigative Site US080

San Antonio, Texas 78229

United States

Investigative Site US063

San Antonio, Texas 78240

United States

Investigative Site US053

Salt Lake City, Utah 84112

United States

Investigative Site US076

Charlottesville, Virginia 22903

United States

Investigative Site US057

Fairfax, Virginia 22031

United States

Investigative Site US065

Fairfax, Virginia 22031

United States

Investigative Site US064

Salem, Virginia 24153

United States

Investigative Site US081

Olympia, Washington 98506

United States

Investigative Site US032

Seattle, Washington 98122

United States

Investigative Site US044

Madison, Wisconsin 53792

United States

Investigative Site AU007

Liverpool, New South Wales 02170

Australia

Investigative Site AU006

Woodville South, South Australia 05011

Australia

Investigative Site AU004

Melbourne, Victoria 03000

Australia

Investigative Site AU001

Melbourne, Victoria 03004

Australia

Investigative Site AU005

Richmond, Victoria 03121

Australia

Investigative Site AU002

Canberra, 02605

Australia

Investigative Site AU008

Perth, 06009

Australia

Investigative Site AT002

Innsbruck, 06020

Austria

Investigative Site AT004

Linz, 04010

Austria

Investigative Site AT003

Salzburg, 05020

Austria

Investigative Site BE008

Anderlecht, 01070

Belgium

Investigative Site BE003

Brussels, 01090

Belgium

Investigative Site BE009

Brussels, 01200

Belgium

Investigative Site BE001

Edegem, 02650

Belgium

Investigative Site BE005

Ghent, 09000

Belgium

Investigative Site BE007

Gilly, 06060

Belgium

Investigative Site BE004

Leuven, 03000

Belgium

Investigative Site BE006

Liège, 04000

Belgium

Investigative Site BE002

Yvoir, 05530

Belgium

Investigative Site CA007

Hamilton, Ontario L8V 5C2

Canada

Investigative Site CA008

Kingston, Ontario K7L 5P9

Canada

Investigative Site CA001

Toronto, Ontario M5G 2M9

Canada

Investigative Site CA006

Montreal, Quebec H4A 3J1

Canada

Investigative Site CA004

Québec, Quebec G1J 1Z4

Canada

Investigative Site DK006

Aalborg, 09000

Denmark

Investigative Site DK005

Århus N, 08200

Denmark

Investigative Site DK001

Herlev, 02730

Denmark

Investigative Site DK004

Odense C, 05000

Denmark

Investigative Site DK003

Roskilde, 04000

Denmark

Investigative Site DK002

Vejle, 07100

Denmark

Investigative Site FI001

Helsinki, 00029

Finland

Investigative Site FI003

Tampere, 33521

Finland

Investigative Site FI002

Turku, 20521

Finland

Investigative Site FR013

Brest, 29200

France

Investigative Site FR012

Chambray-lès-Tours, 37170

France

Investigative Site FR014

Dijon, 21000

France

Investigative Site FR002

Lille, 59037

France

Investigative Site FR011

Lyon, 69008

France

Investigative Site FR016

Lyon, 69373

France

Investigative Site FR006

Marseille, 13385

France

Investigative Site FR015

Montpellier, 34298

France

Investigative Site FR003

Paris, 75013

France

Investigative Site FR009

Paris, 75015

France

Investigative Site FR004

Pessac, 33604

France

Investigative Site FR008

Poitiers, 86021

France

Investigative Site FR010

Reims, 51100

France

Investigative Site FR005

Rennes, 35042

France

Investigative Site FR007

Toulouse, 31059

France

Investigative Site FR001

Villejuif, 94805

France

Investigative Site DE018

Berlin, 10365

Germany

Investigative Site DE020

Berlin, 13353

Germany

Investigative Site DE003

Bochum, 44791

Germany

Investigative Site DE019

Bonn, 53127

Germany

Investigative Site DE008

Cologne, 50937

Germany

Investigative Site DE001

Dresden, 01307

Germany

Investigative Site DE013

Düsseldorf, 40225

Germany

Investigative Site DE004

Essen, 45147

Germany

Investigative Site DE005

Frankfurt, 60488

Germany

Investigative Site DE016

Freiburg im Breisgau, 79106

Germany

Investigative Site DE017

Göttingen, 37075

Germany

Investigative Site DE002

Halle, 06120

Germany

Investigative Site DE007

Hamburg, 20251

Germany

Investigative Site DE006

Hamburg, 22763

Germany

Investigative Site DE009

Leipzig, 04103

Germany

Investigative Site DE015

Munich, 81377

Germany

Investigative Site DE014

München, 81737

Germany

Investigative Site DE010

Nuremberg, 90419

Germany

Investigative Site DE011

Ulm, 89081

Germany

Investigative Site IT002

Bologna, 40138

Italy

Investigative Site IT010

Brescia, 25124

Italy

Investigative Site IT009

Candiolo, 10060

Italy

Investigative Site IT012

Foggia, 71122

Italy

Investigative Site IT006

Milan, 20132

Italy

Investigative Site IT008

Milan, 20133

Italy

Investigative Site IT011

Naples, 80131

Italy

Investigative Site IT003

Pisa, 56126

Italy

Investigative Site IT004

Roma, 00152

Italy

Investigative Site IT005

Rome, 00138

Italy

Investigative Site IT001

Rozzano, 20089

Italy

Investigative Site IT007

Verona, 37134

Italy

Investigative Site JP010

Kahoku-gun, 920-0293

Japan

Investigative Site JP002

Kashiwa-shi, 277-8577

Japan

Investigative Site JP003

Kōtoku, 135-8550

Japan

Investigative Site JP007

Mitaka-shi, 181-8611

Japan

Investigative Site JP004

Osaka, 541-8567

Japan

Investigative Site JP009

Shinjuku-ku, 160-0023

Japan

Investigative Site JP006

Toyama, 930-0194

Japan

Investigative Site JP008

Wakayama, 641-8510

Japan

Investigative Site JP001

Yokohama, 241-8515

Japan

Investigative Site NL001

Amsterdam, 1081 HV

Netherlands

Investigative Site NL007

Eindhoven, 5623 EJ

Netherlands

Investigative Site NL005

Groningen, 9700 RB

Netherlands

Investigative Site NL003

Maastricht, 6229 HX

Netherlands

Investigative Site NL006

Utrecht, 3543 AZ

Netherlands

Investigative Site NO002

Bergen, 05021

Norway

Investigative Site NO001

Oslo, 00379

Norway

Investigative Site NO005

Stavanger, 04011

Norway

Investigative Site NO003

Trondheim, 07030

Norway

Investigative Site PL008

Gdansk, 80-214

Poland

Investigative Site PL003

Krakow, 31-501

Poland

Investigative Site PL007

Warsaw, 01-748

Poland

Investigative Site PL001

Warsaw, 02-034

Poland

Investigative Site PL002

Warsaw, 02-507

Poland

Investigative Site PL004

Wroclaw, 53-439

Poland

Investigative Site PR001

Dorado, 00646

Puerto Rico

Investigative Site KR004

Goyang-si, 10408

South Korea

Investigative Site KR005

Seongnam, 13620

South Korea

Investigative Site KR007

Seongnam-si, 13496

South Korea

Investigative Site KR002

Seoul, 03080

South Korea

Investigative Site KR006

Seoul, 03722

South Korea

Investigative Site KR001

Seoul, 05505

South Korea

Investigative Site KR003

Seoul, 06351

South Korea

Investigative Site KR008

Seoul, 06591

South Korea

Investigative Site ES011

Badalona, 08916

Spain

Investigative Site ES002

Barcelona, 08011

Spain

Investigative Site ES003

Barcelona, 08035

Spain

Investigative Site ES014

Las Palmas de Gran Canaria, 35016

Spain

Investigative Site ES016

Madrid, 28009

Spain

Investigative Site ES006

Madrid, 28034

Spain

Investigative Site ES007

Madrid, 28040

Spain

Investigative Site ES012

Madrid, 28040

Spain

Investigative Site ES008

Madrid, 28041

Spain

Investigative Site ES013

Madrid, 28050

Spain

Investigative Site ES005

Palma de Mallorca, 07120

Spain

Investigative Site ES009

Santander, 39008

Spain

Investigative Site ES010

Seville, 41009

Spain

Investigative Site ES015

Valencia, 46009

Spain

Investigative Site ES017

Valencia, 46010

Spain

Investigative Site ES001

Valencia, 46014

Spain

Investigative Site ES004

Zaragoza, 50009

Spain

Investigative Site SE003

Linköping, 58185

Sweden

Investigative Site SE001

Lund, 222 42

Sweden

Investigative Site SE002

Solna, 171 76

Sweden

Investigative Site CH005

Basel, 04058

Switzerland

Investigative Site CH003

Bern, 03010

Switzerland

Investigative Site CH004

Geneva, 01205

Switzerland

Investigative Site CH002

Lausanne, 01011

Switzerland

Investigative Site CH001

Zurich, 08091

Switzerland

Investigative Site GB008

Dundee, DD2 1GZ

United Kingdom

Investigative Site GB011

Guildford, GU2 7XX

United Kingdom

Investigative Site GB002

Headington, OX3 7LE

United Kingdom

Investigative Site GB001

Leeds, LS9 7TF

United Kingdom

Investigative Site GB009

London, EC1A 7BE

United Kingdom

Investigative Site GB004

London, NW3 2QG

United Kingdom

Investigative Site GB003

Manchester, M20 4BX

United Kingdom

Investigative Site GB010

Northwood, HA6 2RN

United Kingdom

Investigative Site GB005

Norwich, NR4 7UY

United Kingdom