Clinical trial · NCT07522073

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

RecruitingPhase 3

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).

Interventions

INCB161734 · DRUG
Oral; tablet
Placebo · DRUG
Oral; tablet
Investigator's choice of chemotherapy · DRUG
The investigator will select the chemotherapy in accordance with the protocol-defined requirements. The possible choices as defined by the protocol:

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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.

Sites (228)

Investigative Site US058, Birmingham, Alabama · Not yet recruiting
Investigative Site US016, Anchorage, Alaska · Recruiting
Investigative Site US026, Chandler, Arizona · Recruiting
Investigative Site US045, Tucson, Arizona · Not yet recruiting
Investigative Site US051, Duarte, California · Not yet recruiting
Investigative Site US085, Fullerton, California · Not yet recruiting
Investigative Site US054, La Jolla, California · Not yet recruiting
Investigative Site US086, Long Beach, California · Not yet recruiting
Investigative Site US027, Los Angeles, California · Recruiting
Investigative Site US036, Los Angeles, California · Recruiting
Investigative Site US048, Los Angeles, California · Recruiting
Investigative Site US049, Orange, California · Not yet recruiting
Investigative Site US034, San Francisco, California · Not yet recruiting
Investigative Site US001, Santa Monica, California · Recruiting
Investigative Site US071, Denver, Colorado · Recruiting
Investigative Site US013, Washington D.C., District of Columbia · Not yet recruiting
Investigative Site US046, Washington D.C., District of Columbia · Not yet recruiting
Investigative Site US072, Fort Myers, Florida · Recruiting
Investigative Site US083, Jacksonville, Florida · Not yet recruiting
Investigative Site US075, Miami, Florida · Recruiting
Investigative Site US074, St. Petersburg, Florida · Recruiting
Investigative Site US073, West Palm Beach, Florida · Recruiting
Investigative Site US023, Atlanta, Georgia · Not yet recruiting
Investigative Site US079, Chicago, Illinois · Not yet recruiting
Investigative Site US030, Evanston, Illinois · Not yet recruiting
Investigative Site US005, Naperville, Illinois · Recruiting
Investigative Site US009, Springfield, Illinois · Recruiting
Investigative Site US021, Indianapolis, Indiana · Not yet recruiting
Investigative Site US007, New Orleans, Louisiana · Not yet recruiting
Investigative Site US022, Boston, Massachusetts · Recruiting
Investigative Site US006, Ann Arbor, Michigan · Not yet recruiting
Investigative Site US010, Detroit, Michigan · Recruiting
Investigative Site US078, Grand Rapids, Michigan · Recruiting
Investigative Site US012, Ypsilanti, Michigan · Not yet recruiting
Investigative Site US066, Maple Grove, Minnesota · Recruiting
Investigative Site US047, Hattiesburg, Mississippi · Not yet recruiting
Investigative Site US084, Reno, Nevada · Not yet recruiting
Investigative Site US077, Hackensack, New Jersey · Recruiting
Investigative Site US017, Morristown, New Jersey · Recruiting
Investigative Site US059, Lake Success, New York · Recruiting
Investigative Site US031, New York, New York · Recruiting
Investigative Site US003, New York, New York · Recruiting
Investigative Site US041, New York, New York · Recruiting
Investigative Site US029, The Bronx, New York · Recruiting
Investigative Site US035, Chapel Hill, North Carolina · Recruiting
Investigative Site US050, Cleveland, Ohio · Recruiting
Investigative Site US020, Cleveland, Ohio · Recruiting
Investigative Site US033, Columbus, Ohio · Not yet recruiting
Investigative Site US042, Portland, Oregon · Not yet recruiting
Investigative Site US008, Philadelphia, Pennsylvania · Recruiting
Investigative Site US043, Philadelphia, Pennsylvania · Recruiting
Investigative Site US056, Pittsburgh, Pennsylvania · Not yet recruiting
Investigative Site US082, Charleston, South Carolina · Not yet recruiting
Investigative Site US055, Sioux Falls, South Dakota · Recruiting
Investigative Site US039, Nashville, Tennessee · Not yet recruiting
Investigative Site US060, Nashville, Tennessee · Recruiting
Investigative Site US070, Nashville, Tennessee · Not yet recruiting
Investigative Site US067, Dallas, Texas · Recruiting
Investigative Site US062, Denison, Texas · Recruiting
Investigative Site US011, Houston, Texas · Recruiting
Investigative Site US080, San Antonio, Texas · Not yet recruiting
Investigative Site US063, San Antonio, Texas · Recruiting
Investigative Site US053, Salt Lake City, Utah · Recruiting
Investigative Site US057, Fairfax, Virginia · Not yet recruiting
Investigative Site US065, Fairfax, Virginia · Recruiting
Investigative Site US064, Salem, Virginia · Recruiting
Investigative Site US081, Olympia, Washington · Recruiting
Investigative Site US032, Seattle, Washington · Not yet recruiting
Investigative Site US044, Madison, Wisconsin · Recruiting
Investigative Site AU011, Macquarie Park, New South Wales · Not yet recruiting
Investigative Site AU010, Chermside, Queensland · Not yet recruiting
Investigative Site AU009, Townsville, Queensland · Recruiting
Investigative Site AU006, Woodville South, South Australia · Not yet recruiting
Investigative Site AU004, Melbourne, Victoria · Recruiting
Investigative Site AU001, Melbourne, Victoria · Recruiting
Investigative Site AU005, Richmond, Victoria · Recruiting
Investigative Site AU002, Canberra, Australia · Not yet recruiting
Investigative Site AU008, Perth, Australia · Recruiting
Investigative Site AT002, Innsbruck, Austria · Not yet recruiting
Investigative Site AT004, Linz, Austria · Not yet recruiting
Investigative Site AT003, Salzburg, Austria · Not yet recruiting
Investigative Site BE008, Anderlecht, Belgium · Not yet recruiting
Investigative Site BE003, Brussels, Belgium · Not yet recruiting
Investigative Site BE009, Brussels, Belgium · Not yet recruiting
Investigative Site BE001, Edegem, Belgium · Recruiting
Investigative Site BE005, Ghent, Belgium · Recruiting
Investigative Site BE007, Gilly, Belgium · Not yet recruiting
Investigative Site BE004, Leuven, Belgium · Not yet recruiting
Investigative Site BE006, Liège, Belgium · Not yet recruiting
Investigative Site BE002, Yvoir, Belgium · Not yet recruiting
Investigative Site CA007, Hamilton, Ontario · Not yet recruiting
Investigative Site CA008, Kingston, Ontario · Not yet recruiting
Investigative Site CA001, Toronto, Ontario · Recruiting
Investigative Site CA006, Montreal, Quebec · Not yet recruiting
Investigative Site CA004, Québec, Quebec · Not yet recruiting
Investigative Site DK006, Aalborg, Denmark · Not yet recruiting
Investigative Site DK005, Århus N, Denmark · Not yet recruiting
Investigative Site DK001, Herlev, Denmark · Not yet recruiting
Investigative Site DK003, Køge, Denmark · Not yet recruiting
Investigative Site DK004, Odense C, Denmark · Not yet recruiting
Investigative Site DK002, Vejle, Denmark · Not yet recruiting
Investigative Site FI001, Helsinki, Finland · Not yet recruiting
Investigative Site FI003, Tampere, Finland · Not yet recruiting
Investigative Site FI002, Turku, Finland · Not yet recruiting
Investigative Site FR013, Brest, France · Not yet recruiting
Investigative Site FR014, Dijon, France · Not yet recruiting
Investigative Site FR002, Lille, France · Not yet recruiting
Investigative Site FR011, Lyon, France · Not yet recruiting
Investigative Site FR016, Lyon, France · Not yet recruiting
Investigative Site FR006, Marseille, France · Not yet recruiting
Investigative Site FR015, Montpellier, France · Not yet recruiting
Investigative Site FR003, Paris, France · Not yet recruiting
Investigative Site FR009, Paris, France · Not yet recruiting
Investigative Site FR004, Pessac, France · Not yet recruiting
Investigative Site FR008, Poitiers, France · Not yet recruiting
Investigative Site FR010, Reims, France · Not yet recruiting
Investigative Site FR005, Rennes, France · Not yet recruiting
Investigative Site FR007, Toulouse, France · Not yet recruiting
Investigative Site FR012, Tours, France · Not yet recruiting
Investigative Site FR001, Villejuif, France · Not yet recruiting
Investigative Site GE004, Batumi, Georgia · Not yet recruiting
Investigative Site GE005, Tbilisi, Georgia · Not yet recruiting
Investigative Site GE006, Tbilisi, Georgia · Not yet recruiting
Investigative Site GE001, Tbilisi, Georgia · Not yet recruiting
Investigative Site GE003, Tbilisi, Georgia · Not yet recruiting
Investigative Site DE018, Berlin, Germany · Not yet recruiting
Investigative Site DE020, Berlin, Germany · Not yet recruiting
Investigative Site DE003, Bochum, Germany · Not yet recruiting
Investigative Site DE019, Bonn, Germany · Not yet recruiting
Investigative Site DE008, Cologne, Germany · Not yet recruiting
Investigative Site DE001, Dresden, Germany · Not yet recruiting
Investigative Site DE013, Düsseldorf, Germany · Not yet recruiting
Investigative Site DE004, Essen, Germany · Not yet recruiting
Investigative Site DE005, Frankfurt, Germany · Not yet recruiting
Investigative Site DE016, Freiburg im Breisgau, Germany · Not yet recruiting
Investigative Site DE017, Göttingen, Germany · Not yet recruiting
Investigative Site DE002, Halle, Germany · Not yet recruiting
Investigative Site DE007, Hamburg, Germany · Not yet recruiting
Investigative Site DE006, Hamburg, Germany · Not yet recruiting
Investigative Site DE009, Leipzig, Germany · Not yet recruiting
Investigative Site DE015, Munich, Germany · Not yet recruiting
Investigative Site DE014, München, Germany · Not yet recruiting
Investigative Site DE010, Nuremberg, Germany · Not yet recruiting
Investigative Site DE011, Ulm, Germany · Not yet recruiting
Investigative Site IT002, Bologna, Italy · Not yet recruiting
Investigative Site IT010, Brescia, Italy · Not yet recruiting
Investigative Site IT009, Candiolo, Italy · Not yet recruiting
Investigative Site IT012, Foggia, Italy · Not yet recruiting
Investigative Site IT006, Milan, Italy · Not yet recruiting
Investigative Site IT008, Milan, Italy · Not yet recruiting
Investigative Site IT011, Naples, Italy · Not yet recruiting
Investigative Site IT003, Pisa, Italy · Not yet recruiting
Investigative Site IT004, Roma, Italy · Not yet recruiting
Investigative Site IT005, Rome, Italy · Not yet recruiting
Investigative Site IT001, Rozzano, Italy · Not yet recruiting
Investigative Site IT007, Verona, Italy · Not yet recruiting
Investigative Site JP015, Akashi, HYGO, Japan · Active, not recruiting
Investigative Site JP012, Fukuoka Fukuoka, Japan · Not yet recruiting
Investigative Site JP010, Kahoku-gun, Japan · Recruiting
Investigative Site JP014, Kitaadachi-gun, Japan · Not yet recruiting
Investigative Site JP003, Kōtoku, Japan · Recruiting
Investigative Site JP007, Mitaka-shi, Japan · Recruiting
Investigative Site JP004, Osaka, Japan · Recruiting
Investigative Site JP011, Sapporo Hokkaido, Japan · Not yet recruiting
Investigative Site JP009, Shinjuku-ku, Japan · Recruiting
Investigative Site JP013, Suita, Osaka, Japan · Not yet recruiting
Investigative Site JP006, Toyama, Japan · Recruiting
Investigative Site JP008, Wakayama, Japan · Recruiting
Investigative Site JP001, Yokohama, Japan · Recruiting
Investigative Site NL001, Amsterdam, Netherlands · Not yet recruiting
Investigative Site NL007, Eindhoven, Netherlands · Not yet recruiting
Investigative Site NL005, Groningen, Netherlands · Not yet recruiting
Investigative Site NL003, Maastricht, Netherlands · Not yet recruiting
Investigative Site NL006, Utrecht, Netherlands · Not yet recruiting
Investigative Site NZ001, Auckland, New Zealand · Not yet recruiting
Investigative Site NO002, Bergen, Norway · Not yet recruiting
Investigative Site NO001, Oslo, Norway · Not yet recruiting
Investigative Site NO005, Stavanger, Norway · Not yet recruiting
Investigative Site NO003, Trondheim, Norway · Not yet recruiting
Investigative Site PL008, Gdansk, Poland · Not yet recruiting
Investigative Site PL003, Krakow, Poland · Not yet recruiting
Investigative Site PL007, Warsaw, Poland · Not yet recruiting
Investigative Site PL001, Warsaw, Poland · Not yet recruiting
Investigative Site PL002, Warsaw, Poland · Not yet recruiting
Investigative Site PL004, Wroclaw, Poland · Not yet recruiting
Investigative Site PR001, Dorado, Puerto Rico · Recruiting
Investigative Site KR004, Goyang-si, South Korea · Recruiting
Investigative Site KR007, Seongnam-si, South Korea · Not yet recruiting
Investigative Site KR005, Seongnam-si, South Korea · Not yet recruiting
Investigative Site KR002, Seoul, South Korea · Recruiting
Investigative Site KR006, Seoul, South Korea · Not yet recruiting
Investigative Site KR001, Seoul, South Korea · Recruiting
Investigative Site KR003, Seoul, South Korea · Not yet recruiting
Investigative Site KR008, Seoul, South Korea · Not yet recruiting
Investigative Site ES011, Badalona, Spain · Not yet recruiting
Investigative Site ES002, Barcelona, Spain · Not yet recruiting
Investigative Site ES003, Barcelona, Spain · Not yet recruiting
Investigative Site ES014, Las Palmas de Gran Canaria, Spain · Not yet recruiting
Investigative Site ES016, Madrid, Spain · Not yet recruiting
Investigative Site ES006, Madrid, Spain · Not yet recruiting
Investigative Site ES007, Madrid, Spain · Not yet recruiting
Investigative Site ES012, Madrid, Spain · Not yet recruiting
Investigative Site ES008, Madrid, Spain · Not yet recruiting
Investigative Site ES013, Madrid, Spain · Not yet recruiting
Investigative Site ES005, Palma de Mallorca, Spain · Not yet recruiting
Investigative Site ES009, Santander, Spain · Not yet recruiting
Investigative Site ES010, Seville, Spain · Not yet recruiting
Investigative Site ES015, Valencia, Spain · Not yet recruiting
Investigative Site ES017, Valencia, Spain · Not yet recruiting
Investigative Site ES001, Valencia, Spain · Not yet recruiting
Investigative Site ES004, Zaragoza, Spain · Not yet recruiting
Investigative Site SE003, Linköping, Sweden · Not yet recruiting
Investigative Site SE001, Lund, Sweden · Not yet recruiting
Investigative Site SE002, Stockholm, Sweden · Not yet recruiting
Investigative Site CH005, Basel, Switzerland · Not yet recruiting
Investigative Site CH003, Bern, Switzerland · Not yet recruiting
Investigative Site CH004, Geneva, Switzerland · Not yet recruiting
Investigative Site CH002, Lausanne, Switzerland · Not yet recruiting
Investigative Site CH001, Zurich, Switzerland · Not yet recruiting
Investigative Site GB008, Dundee, United Kingdom · Not yet recruiting
Investigative Site GB011, Guildford, United Kingdom · Not yet recruiting
Investigative Site GB002, Headington, United Kingdom · Not yet recruiting
Investigative Site GB001, Leeds, United Kingdom · Not yet recruiting
Investigative Site GB009, London, United Kingdom · Not yet recruiting
Investigative Site GB004, London, United Kingdom · Not yet recruiting
Investigative Site GB003, Manchester, United Kingdom · Not yet recruiting
Investigative Site GB010, Northwood, United Kingdom · Not yet recruiting
Investigative Site GB005, Norwich, United Kingdom · Not yet recruiting

Not medical advice. Trial0 is a navigation service, not a medical provider. Nothing here is medical advice or a recommendation to pursue any treatment; eligibility matching is informational, based on published registry criteria, and only the trial site or treating clinician can determine actual eligibility. Decisions belong with the patient and their own doctors. Registry data refreshed at most hourly; last update posted 2026-09-22.