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

Last updated: May 7, 2026
Sponsor: Incyte Corporation
Overall Status: Active - Recruiting

Phase

3

Condition

Digestive System Neoplasms

Solid Tumors

Treatment

Placebo

INCB161734

Investigator's choice of chemotherapy

Clinical Study ID

NCT07522073
INCB161734-303
  • Ages > 18
  • All Genders

Study 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

Inclusion

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

Exclusion Criteria:

  • Prior treatment with any KRAS inhibitor

  • Chronic or current active infection requiring systemic treatment within 1 week priorto the first dose of study drug

  • Known active CNS metastases

Other protocol-defined Inclusion/Exclusion Criteria may apply.

Study Design

Total Participants: 588
Treatment Group(s): 3
Primary Treatment: Placebo
Phase: 3
Study Start date:
April 09, 2026
Estimated Completion Date:
March 19, 2029

Connect with a study center

  • Investigative Site AU007

    Liverpool, New South Wales 02170
    Australia

    Site Not Available

  • Investigative Site AU003

    Wollongong, New South Wales 02500
    Australia

    Site Not Available

  • Investigative Site AU006

    Woodville South, South Australia 05011
    Australia

    Site Not Available

  • Investigative Site AU005

    Box Hill, Victoria 03128
    Australia

    Site Not Available

  • Investigative Site AU001

    Melbourne, Victoria 03004
    Australia

    Site Not Available

  • Investigative Site AU004

    Melbourne, Victoria 03000
    Australia

    Site Not Available

  • Investigative Site AU002

    Canberra, 02605
    Australia

    Site Not Available

  • Investigative Site AU008

    Perth, 06009
    Australia

    Site Not Available

  • Investigative Site AT002

    Innsbruck, 06020
    Austria

    Site Not Available

  • Investigative Site AT004

    Linz, 04010
    Austria

    Site Not Available

  • Investigative Site AT003

    Salzburg, 05020
    Austria

    Site Not Available

  • Investigative Site AT001

    Vienna, 01090
    Austria

    Site Not Available

  • Investigative Site BE008

    Anderlecht, 01070
    Belgium

    Site Not Available

  • Investigative Site BE003

    Brussels, 01090
    Belgium

    Site Not Available

  • Investigative Site BE009

    Brussels, 01200
    Belgium

    Site Not Available

  • Investigative Site BE001

    Edegem, 02650
    Belgium

    Site Not Available

  • Investigative Site BE005

    Ghent, 09000
    Belgium

    Site Not Available

  • Investigative Site BE007

    Gilly, 06060
    Belgium

    Site Not Available

  • Investigative Site BE004

    Leuven, 03000
    Belgium

    Site Not Available

  • Investigative Site BE006

    Liège, 04000
    Belgium

    Site Not Available

  • Investigative Site BE002

    Yvoir, 05530
    Belgium

    Site Not Available

  • Investigative Site CA001

    Toronto, Ontario M5G 2M9
    Canada

    Site Not Available

  • Investigative Site CA005

    Laval, Quebec H7M 3L9
    Canada

    Site Not Available

  • Investigative Site CA006

    Montreal, Quebec H4A 3J1
    Canada

    Site Not Available

  • Investigative Site CA004

    Québec, Quebec G1J 1Z4
    Canada

    Site Not Available

  • Investigative Site DK006

    Aalborg, 09000
    Denmark

    Site Not Available

  • Investigative Site DK001

    Herlev, 02730
    Denmark

    Site Not Available

  • Investigative Site DK004

    Odense C, 05000
    Denmark

    Site Not Available

  • Investigative Site DK003

    Roskilde, 04000
    Denmark

    Site Not Available

  • Investigative Site DK002

    Vejle, 07100
    Denmark

    Site Not Available

  • Investigative Site DK005

    Århus N, 08200
    Denmark

    Site Not Available

  • Investigative Site FI001

    Helsinki, 00029
    Finland

    Site Not Available

  • Investigative Site FI003

    Tampere, 33521
    Finland

    Site Not Available

  • Investigative Site FI002

    Turku, 20521
    Finland

    Site Not Available

  • Investigative Site FR013

    Brest, 29200
    France

    Site Not Available

  • Investigative Site FR012

    Chambray-lès-Tours, 37170
    France

    Site Not Available

  • Investigative Site FR014

    Dijon, 21000
    France

    Site Not Available

  • Investigative Site FR002

    Lille, 59037
    France

    Site Not Available

  • Investigative Site FR011

    Lyon, 69008
    France

    Site Not Available

  • Investigative Site FR016

    Lyon, 69373
    France

    Site Not Available

  • Investigative Site FR006

    Marseille, 13385
    France

    Site Not Available

  • Investigative Site FR015

    Montpellier, 34298
    France

    Site Not Available

  • Investigative Site FR003

    Paris, 75013
    France

    Site Not Available

  • Investigative Site FR009

    Paris, 75015
    France

    Site Not Available

  • Investigative Site FR004

    Pessac, 33604
    France

    Site Not Available

  • Investigative Site FR008

    Poitiers, 86021
    France

    Site Not Available

  • Investigative Site FR010

    Reims, 51100
    France

    Site Not Available

  • Investigative Site FR005

    Rennes, 35042
    France

    Site Not Available

  • Investigative Site FR007

    Toulouse, 31059
    France

    Site Not Available

  • Investigative Site FR001

    Villejuif, 94805
    France

    Site Not Available

  • Investigative Site DE018

    Berlin, 10365
    Germany

    Site Not Available

  • Investigative Site DE020

    Berlin, 13353
    Germany

    Site Not Available

  • Investigative Site DE003

    Bochum, 44791
    Germany

    Site Not Available

  • Investigative Site DE019

    Bonn, 53127
    Germany

    Site Not Available

  • Investigative Site DE008

    Cologne, 50937
    Germany

    Site Not Available

  • Investigative Site DE001

    Dresden, 01307
    Germany

    Site Not Available

  • Investigative Site DE013

    Düsseldorf, 40225
    Germany

    Site Not Available

  • Investigative Site DE004

    Essen, 45147
    Germany

    Site Not Available

  • Investigative Site DE005

    Frankfurt, 60488
    Germany

    Site Not Available

  • Investigative Site DE016

    Freiburg im Breisgau, 79106
    Germany

    Site Not Available

  • Investigative Site DE017

    Göttingen, 37075
    Germany

    Site Not Available

  • Investigative Site DE002

    Halle, 06120
    Germany

    Site Not Available

  • Investigative Site DE006

    Hamburg, 22763
    Germany

    Site Not Available

  • Investigative Site DE007

    Hamburg, 20246
    Germany

    Site Not Available

  • Investigative Site DE009

    Leipzig, 04103
    Germany

    Site Not Available

  • Investigative Site DE015

    Munich, 81377
    Germany

    Site Not Available

  • Investigative Site DE014

    München, 81737
    Germany

    Site Not Available

  • Investigative Site DE010

    Nuremberg, 90419
    Germany

    Site Not Available

  • Investigative Site DE011

    Ulm, 89081
    Germany

    Site Not Available

  • Investigative Site IT002

    Bologna, 40138
    Italy

    Site Not Available

  • Investigative Site IT010

    Brescia, 25124
    Italy

    Site Not Available

  • Investigative Site IT009

    Candiolo, 10060
    Italy

    Site Not Available

  • Investigative Site IT012

    Foggia, 71122
    Italy

    Site Not Available

  • Investigative Site IT006

    Milan, 20132
    Italy

    Site Not Available

  • Investigative Site IT008

    Milan, 20133
    Italy

    Site Not Available

  • Investigative Site IT011

    Naples, 80131
    Italy

    Site Not Available

  • Investigative Site IT003

    Pisa, 56126
    Italy

    Site Not Available

  • Investigative Site IT004

    Roma, 00152
    Italy

    Site Not Available

  • Investigative Site IT005

    Rome, 00138
    Italy

    Site Not Available

  • Investigative Site IT001

    Rozzano, 20089
    Italy

    Site Not Available

  • Investigative Site IT007

    Verona, 37134
    Italy

    Site Not Available

  • Investigative Site JP002

    Kashiwa-shi, 277-8577
    Japan

    Site Not Available

  • Investigative Site JP003

    Kōtoku, 135-8550
    Japan

    Site Not Available

  • Investigative Site JP007

    Mitaka-shi, 181-8611
    Japan

    Site Not Available

  • Investigative Site JP004

    Osaka, 541-8567
    Japan

    Site Not Available

  • Investigative Site JP009

    Shinjuku-ku, 160-0023
    Japan

    Site Not Available

  • Investigative Site JP006

    Toyama, 930-0194
    Japan

    Site Not Available

  • Investigative Site JP008

    Wakayama, 641-8510
    Japan

    Site Not Available

  • Investigative Site JP001

    Yokohama, 241-8515
    Japan

    Site Not Available

  • Investigative Site NL001

    Amsterdam, 1081 HV
    Netherlands

    Site Not Available

  • Investigative Site NL007

    Eindhoven, 5623 EJ
    Netherlands

    Site Not Available

  • Investigative Site NL005

    Groningen, 9700 RB
    Netherlands

    Site Not Available

  • Investigative Site NL003

    Maastricht, 6202 AZ
    Netherlands

    Site Not Available

  • Investigative Site NL006

    Nieuwegein, 3430 EM
    Netherlands

    Site Not Available

  • Investigative Site NO002

    Bergen, 05021
    Norway

    Site Not Available

  • Investigative Site NO001

    Oslo, 00379
    Norway

    Site Not Available

  • Investigative Site NO005

    Stavanger, 04011
    Norway

    Site Not Available

  • Investigative Site NO003

    Trondheim, 07030
    Norway

    Site Not Available

  • Investigative Site PL008

    Gdansk, 80-214
    Poland

    Site Not Available

  • Investigative Site PL003

    Krakow, 31-501
    Poland

    Site Not Available

  • Investigative Site PL001

    Warsaw, 02-034
    Poland

    Site Not Available

  • Investigative Site PL002

    Warsaw, 02-507
    Poland

    Site Not Available

  • Investigative Site PL007

    Warsaw, 01-748
    Poland

    Site Not Available

  • Investigative Site PL004

    Wroclaw, 53-439
    Poland

    Site Not Available

  • Investigative Site PR001

    Dorado, 00646
    Puerto Rico

    Active - Recruiting

  • Investigative Site KR004

    Goyang-si, 10408
    South Korea

    Site Not Available

  • Investigative Site KR005

    Seongnam, 13620
    South Korea

    Site Not Available

  • Investigative Site KR007

    Seongnam-si, 13496
    South Korea

    Site Not Available

  • Investigative Site KR001

    Seoul, 05505
    South Korea

    Site Not Available

  • Investigative Site KR002

    Seoul, 03080
    South Korea

    Site Not Available

  • Investigative Site KR003

    Seoul, 06351
    South Korea

    Site Not Available

  • Investigative Site KR006

    Seoul, 03722
    South Korea

    Site Not Available

  • Investigative Site KR008

    Seoul, 06591
    South Korea

    Site Not Available

  • Investigative Site ES011

    Badalona, 08916
    Spain

    Site Not Available

  • Investigative Site ES002

    Barcelona, 08036
    Spain

    Site Not Available

  • Investigative Site ES003

    Barcelona, 08035
    Spain

    Site Not Available

  • Investigative Site ES014

    Las Palmas de Gran Canaria, 35016
    Spain

    Site Not Available

  • Investigative Site ES006

    Madrid, 28034
    Spain

    Site Not Available

  • Investigative Site ES007

    Madrid, 28040
    Spain

    Site Not Available

  • Investigative Site ES008

    Madrid, 28041
    Spain

    Site Not Available

  • Investigative Site ES012

    Madrid, 28040
    Spain

    Site Not Available

  • Investigative Site ES013

    Madrid, 28050
    Spain

    Site Not Available

  • Investigative Site ES016

    Madrid, 28007
    Spain

    Site Not Available

  • Investigative Site ES005

    Palma de Mallorca, 07120
    Spain

    Site Not Available

  • Investigative Site ES009

    Santander, 39012
    Spain

    Site Not Available

  • Investigative Site ES010

    Seville, 41009
    Spain

    Site Not Available

  • Investigative Site ES001

    Valencia, 46014
    Spain

    Site Not Available

  • Investigative Site ES015

    Valencia, 46009
    Spain

    Site Not Available

  • Investigative Site ES017

    Valencia, 46010
    Spain

    Site Not Available

  • Investigative Site ES004

    Zaragoza, 50009
    Spain

    Site Not Available

  • Investigative Site SE003

    Linköping, 58185
    Sweden

    Site Not Available

  • Investigative Site SE001

    Malmo, 21428
    Sweden

    Site Not Available

  • Investigative Site SE001

    Malmö, 21428
    Sweden

    Site Not Available

  • Investigative Site SE002

    Solna, 171 76
    Sweden

    Site Not Available

  • Investigative Site CH005

    Basel, 04058
    Switzerland

    Site Not Available

  • Investigative Site CH003

    Bern, 03010
    Switzerland

    Site Not Available

  • Investigative Site CH004

    Geneva, 01205
    Switzerland

    Site Not Available

  • Investigative Site CH002

    Lausanne, 01011
    Switzerland

    Site Not Available

  • Investigative Site CH001

    Zurich, 08091
    Switzerland

    Site Not Available

  • Investigative Site GB008

    Dundee, DD1 9SY
    United Kingdom

    Site Not Available

  • Investigative Site GB011

    Guildford, GU2 7XX
    United Kingdom

    Site Not Available

  • Investigative Site GB002

    Headington, OX3 7LE
    United Kingdom

    Site Not Available

  • Investigative Site GB001

    Leeds, LS9 7TF
    United Kingdom

    Site Not Available

  • Investigative Site GB004

    London, NW3 2QG
    United Kingdom

    Site Not Available

  • Investigative Site GB009

    London, EC1A 7BE
    United Kingdom

    Site Not Available

  • Investigative Site GB003

    Manchester, M20 4BX
    United Kingdom

    Site Not Available

  • Investigative Site GB006

    Metropolitan Borough of Wirral, CH63 4JY
    United Kingdom

    Site Not Available

  • Investigative Site GB010

    Northwood, HA6 2RN
    United Kingdom

    Site Not Available

  • Investigative Site GB005

    Norwich, NR4 7UY
    United Kingdom

    Site Not Available

  • Investigative Site US058

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Investigative Site US016

    Anchorage, Alaska 99508
    United States

    Active - Recruiting

  • Investigative Site US026

    Chandler, Arizona 85224
    United States

    Site Not Available

  • Investigative Site US045

    Tucson, Arizona 85719
    United States

    Site Not Available

  • Investigative Site US051

    Duarte, California 91010
    United States

    Site Not Available

  • Investigative Site US048

    Fountain Valley, California 92708
    United States

    Site Not Available

  • Investigative Site US049

    Irvine, California 92612
    United States

    Site Not Available

  • Investigative Site US054

    La Jolla, California 92093
    United States

    Site Not Available

  • Investigative Site US019

    Los Angeles, California 90048
    United States

    Site Not Available

  • Investigative Site US027

    Los Angeles, California 90027
    United States

    Site Not Available

  • Investigative Site US036

    Los Angeles, California 90033
    United States

    Site Not Available

  • Investigative Site US034

    San Francisco, California 94143
    United States

    Site Not Available

  • Investigative Site US001

    Santa Monica, California 90404
    United States

    Site Not Available

  • Investigative Site US071

    Denver, Colorado 80218
    United States

    Active - Recruiting

  • Investigative Site US013

    Washington D.C., District of Columbia 20007
    United States

    Site Not Available

  • Investigative Site US046

    Washington D.C., District of Columbia 20016
    United States

    Site Not Available

  • Investigative Site US072

    Fort Myers, Florida 33901
    United States

    Active - Recruiting

  • Investigative Site US075

    Miami, Florida 33136
    United States

    Site Not Available

  • Investigative Site US074

    St. Petersburg, Florida 33701-4553
    United States

    Active - Recruiting

  • Investigative Site US073

    West Palm Beach, Florida 33401
    United States

    Active - Recruiting

  • Investigative Site US074

    Winter Park, Florida 32789
    United States

    Site Not Available

  • Investigative Site US023

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Investigative Site US079

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Investigative Site US030

    Evanston, Illinois 60201
    United States

    Site Not Available

  • Investigative Site US005

    Naperville, Illinois 60540
    United States

    Site Not Available

  • Investigative Site US009

    Springfield, Illinois 62702
    United States

    Site Not Available

  • Investigative Site US021

    Indianapolis, Indiana 46250
    United States

    Site Not Available

  • Investigative Site US007

    New Orleans, Louisiana 70121
    United States

    Site Not Available

  • Investigative Site US022

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Investigative Site US006

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Investigative Site US010

    Detroit, Michigan 48201
    United States

    Site Not Available

  • Investigative Site US078

    Grand Rapids, Michigan 49546
    United States

    Site Not Available

  • Investigative Site US012

    Ypsilanti, Michigan 48197
    United States

    Site Not Available

  • Investigative Site US066

    Maple Grove, Minnesota 55369
    United States

    Site Not Available

  • Investigative Site US047

    Hattiesburg, Mississippi 39401
    United States

    Site Not Available

  • Investigative Site US077

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Investigative Site US017

    Morristown, New Jersey 07960
    United States

    Site Not Available

  • Investigative Site US059

    Lake Success, New York 11042
    United States

    Active - Recruiting

  • Investigative Site US003

    New York, New York 10065
    United States

    Site Not Available

  • Investigative Site US004

    New York, New York 10032
    United States

    Site Not Available

  • Investigative Site US031

    New York, New York 10016
    United States

    Site Not Available

  • Investigative Site US041

    New York, New York 10029
    United States

    Site Not Available

  • Investigative Site US029

    The Bronx, New York 10461
    United States

    Site Not Available

  • Investigative Site US035

    Chapel Hill, North Carolina 27514
    United States

    Site Not Available

  • Investigative Site US020

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Investigative Site US050

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Investigative Site US033

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Investigative Site US042

    Portland, Oregon 97239
    United States

    Site Not Available

  • Investigative Site US008

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Investigative Site US043

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Investigative Site US056

    Pittsburgh, Pennsylvania 15212
    United States

    Site Not Available

  • Investigative Site US055

    Sioux Falls, South Dakota 57105
    United States

    Site Not Available

  • Investigative Site US039

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Investigative Site US060

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Investigative Site US070

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Investigative Site US067

    Dallas, Texas 75246
    United States

    Active - Recruiting

  • Investigative Site US062

    Denison, Texas 75020
    United States

    Active - Recruiting

  • Investigative Site US011

    Houston, Texas 77030
    United States

    Site Not Available

  • Investigative Site US018

    Houston, Texas 77030
    United States

    Site Not Available

  • Investigative Site US063

    San Antonio, Texas 78240
    United States

    Active - Recruiting

  • Investigative Site US053

    Salt Lake City, Utah 84112
    United States

    Site Not Available

  • Investigative Site US076

    Charlottesville, Virginia 22903
    United States

    Site Not Available

  • Investigative Site US057

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • Investigative Site US065

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • Investigative Site US064

    Salem, Virginia 24153
    United States

    Active - Recruiting

  • Investigative Site US032

    Seattle, Washington 98122
    United States

    Site Not Available

  • Investigative Site US044

    Madison, Wisconsin 53706
    United States

    Site Not Available

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