A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma (DAWN-303)

May 29, 2026 updated by: Incyte Corporation

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)

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
588

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Incyte Corporation Call Center (US)
  • Phone Number: 1.855.463.3463
  • Email: medinfo@incyte.com

Study Contact Backup

  • Name: Incyte Corporation Call Center (ex-US)
  • Phone Number: +800 00027423
  • Email: eumedinfo@incyte.com

Study Locations

  • Australia
      • Canberra, Australia, 02605
        • Not yet recruiting
        • Investigative Site AU002
      • Perth, Australia, 06009
        • Not yet recruiting
        • Investigative Site AU008
    • New South Wales
      • Liverpool, New South Wales, Australia, 02170
        • Not yet recruiting
        • Investigative Site AU007
      • Wollongong, New South Wales, Australia, 02500
        • Not yet recruiting
        • Investigative Site AU003
    • South Australia
      • Woodville South, South Australia, Australia, 05011
        • Not yet recruiting
        • Investigative Site AU006
    • Victoria
      • Melbourne, Victoria, Australia, 03000
        • Not yet recruiting
        • Investigative Site AU004
      • Melbourne, Victoria, Australia, 03004
        • Not yet recruiting
        • Investigative Site AU001
      • Richmond, Victoria, Australia, 03121
        • Not yet recruiting
        • Investigative Site AU005
  • Austria
      • Innsbruck, Austria, 06020
        • Not yet recruiting
        • Investigative Site AT002
      • Linz, Austria, 04010
        • Not yet recruiting
        • Investigative Site AT004
      • Salzburg, Austria, 05020
        • Not yet recruiting
        • Investigative Site AT003
      • Vienna, Austria, 01090
        • Not yet recruiting
        • Investigative Site AT001
  • Belgium
      • Anderlecht, Belgium, 01070
        • Not yet recruiting
        • Investigative Site BE008
      • Brussels, Belgium, 01090
        • Not yet recruiting
        • Investigative Site BE003
      • Brussels, Belgium, 01200
        • Not yet recruiting
        • Investigative Site BE009
      • Edegem, Belgium, 02650
        • Not yet recruiting
        • Investigative Site BE001
      • Ghent, Belgium, 09000
        • Not yet recruiting
        • Investigative Site BE005
      • Gilly, Belgium, 06060
        • Not yet recruiting
        • Investigative Site BE007
      • Leuven, Belgium, 03000
        • Not yet recruiting
        • Investigative Site BE004
      • Liège, Belgium, 04000
        • Not yet recruiting
        • Investigative Site BE006
      • Yvoir, Belgium, 05530
        • Not yet recruiting
        • Investigative Site BE002
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Not yet recruiting
        • Investigative Site CA001
    • Quebec
      • Laval, Quebec, Canada, H7M 3L9
        • Not yet recruiting
        • Investigative Site CA005
      • Montreal, Quebec, Canada, H4A 3J1
        • Not yet recruiting
        • Investigative Site CA006
      • Québec, Quebec, Canada, G1J 1Z4
        • Not yet recruiting
        • Investigative Site CA004
  • Denmark
      • Aalborg, Denmark, 09000
        • Not yet recruiting
        • Investigative Site DK006
      • Herlev, Denmark, 02730
        • Not yet recruiting
        • Investigative Site DK001
      • Odense C, Denmark, 05000
        • Not yet recruiting
        • Investigative Site DK004
      • Roskilde, Denmark, 04000
        • Not yet recruiting
        • Investigative Site DK003
      • Vejle, Denmark, 07100
        • Not yet recruiting
        • Investigative Site DK002
      • Århus N, Denmark, 08200
        • Not yet recruiting
        • Investigative Site DK005
  • Finland
      • Helsinki, Finland, 00029
        • Not yet recruiting
        • Investigative Site FI001
      • Tampere, Finland, 33521
        • Not yet recruiting
        • Investigative Site FI003
      • Turku, Finland, 20521
        • Not yet recruiting
        • Investigative Site FI002
  • France
      • Brest, France, 29200
        • Not yet recruiting
        • Investigative Site FR013
      • Chambray-lès-Tours, France, 37170
        • Not yet recruiting
        • Investigative Site FR012
      • Dijon, France, 21000
        • Not yet recruiting
        • Investigative Site FR014
      • Lille, France, 59037
        • Not yet recruiting
        • Investigative Site FR002
      • Lyon, France, 69008
        • Not yet recruiting
        • Investigative Site FR011
      • Lyon, France, 69373
        • Not yet recruiting
        • Investigative Site FR016
      • Marseille, France, 13385
        • Not yet recruiting
        • Investigative Site FR006
      • Montpellier, France, 34298
        • Not yet recruiting
        • Investigative Site FR015
      • Paris, France, 75013
        • Not yet recruiting
        • Investigative Site FR003
      • Paris, France, 75015
        • Not yet recruiting
        • Investigative Site FR009
      • Pessac, France, 33604
        • Not yet recruiting
        • Investigative Site FR004
      • Poitiers, France, 86021
        • Not yet recruiting
        • Investigative Site FR008
      • Reims, France, 51100
        • Not yet recruiting
        • Investigative Site FR010
      • Rennes, France, 35042
        • Not yet recruiting
        • Investigative Site FR005
      • Toulouse, France, 31059
        • Not yet recruiting
        • Investigative Site FR007
      • Villejuif, France, 94805
        • Not yet recruiting
        • Investigative Site FR001
  • Germany
      • Berlin, Germany, 10365
        • Not yet recruiting
        • Investigative Site DE018
      • Berlin, Germany, 13353
        • Not yet recruiting
        • Investigative Site DE020
      • Bochum, Germany, 44791
        • Not yet recruiting
        • Investigative Site DE003
      • Bonn, Germany, 53127
        • Not yet recruiting
        • Investigative Site DE019
      • Cologne, Germany, 50937
        • Not yet recruiting
        • Investigative Site DE008
      • Dresden, Germany, 01307
        • Not yet recruiting
        • Investigative Site DE001
      • Düsseldorf, Germany, 40225
        • Not yet recruiting
        • Investigative Site DE013
      • Essen, Germany, 45147
        • Not yet recruiting
        • Investigative Site DE004
      • Frankfurt, Germany, 60488
        • Not yet recruiting
        • Investigative Site DE005
      • Freiburg im Breisgau, Germany, 79106
        • Not yet recruiting
        • Investigative Site DE016
      • Göttingen, Germany, 37075
        • Not yet recruiting
        • Investigative Site DE017
      • Halle, Germany, 06120
        • Not yet recruiting
        • Investigative Site DE002
      • Hamburg, Germany, 20246
        • Not yet recruiting
        • Investigative Site DE007
      • Hamburg, Germany, 22763
        • Not yet recruiting
        • Investigative Site DE006
      • Leipzig, Germany, 04103
        • Not yet recruiting
        • Investigative Site DE009
      • Munich, Germany, 81377
        • Not yet recruiting
        • Investigative Site DE015
      • München, Germany, 81737
        • Not yet recruiting
        • Investigative Site DE014
      • Nuremberg, Germany, 90419
        • Not yet recruiting
        • Investigative Site DE010
      • Ulm, Germany, 89081
        • Not yet recruiting
        • Investigative Site DE011
  • Italy
      • Bologna, Italy, 40138
        • Not yet recruiting
        • Investigative Site IT002
      • Brescia, Italy, 25124
        • Not yet recruiting
        • Investigative Site IT010
      • Candiolo, Italy, 10060
        • Not yet recruiting
        • Investigative Site IT009
      • Foggia, Italy, 71122
        • Not yet recruiting
        • Investigative Site IT012
      • Milan, Italy, 20132
        • Not yet recruiting
        • Investigative Site IT006
      • Milan, Italy, 20133
        • Not yet recruiting
        • Investigative Site IT008
      • Naples, Italy, 80131
        • Not yet recruiting
        • Investigative Site IT011
      • Pisa, Italy, 56126
        • Not yet recruiting
        • Investigative Site IT003
      • Roma, Italy, 00152
        • Not yet recruiting
        • Investigative Site IT004
      • Rome, Italy, 00138
        • Not yet recruiting
        • Investigative Site IT005
      • Rozzano, Italy, 20089
        • Not yet recruiting
        • Investigative Site IT001
      • Verona, Italy, 37134
        • Not yet recruiting
        • Investigative Site IT007
  • Japan
      • Kashiwa-shi, Japan, 277-8577
        • Not yet recruiting
        • Investigative Site JP002
      • Kōtoku, Japan, 135-8550
        • Recruiting
        • Investigative Site JP003
      • Mitaka-shi, Japan, 181-8611
        • Not yet recruiting
        • Investigative Site JP007
      • Osaka, Japan, 541-8567
        • Not yet recruiting
        • Investigative Site JP004
      • Shinjuku-ku, Japan, 160-0023
        • Not yet recruiting
        • Investigative Site JP009
      • Toyama, Japan, 930-0194
        • Not yet recruiting
        • Investigative Site JP006
      • Wakayama, Japan, 641-8510
        • Not yet recruiting
        • Investigative Site JP008
      • Yokohama, Japan, 241-8515
        • Not yet recruiting
        • Investigative Site JP001
  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
        • Not yet recruiting
        • Investigative Site NL001
      • Eindhoven, Netherlands, 5623 EJ
        • Not yet recruiting
        • Investigative Site NL007
      • Groningen, Netherlands, 9700 RB
        • Not yet recruiting
        • Investigative Site NL005
      • Maastricht, Netherlands, 6202 AZ
        • Not yet recruiting
        • Investigative Site NL003
      • Utrecht, Netherlands, 3543 AZ
        • Not yet recruiting
        • Investigative Site NL006
  • Norway
      • Bergen, Norway, 05021
        • Not yet recruiting
        • Investigative Site NO002
      • Oslo, Norway, 00379
        • Not yet recruiting
        • Investigative Site NO001
      • Stavanger, Norway, 04011
        • Not yet recruiting
        • Investigative Site NO005
      • Trondheim, Norway, 07030
        • Not yet recruiting
        • Investigative Site NO003
  • Poland
      • Gdansk, Poland, 80-214
        • Not yet recruiting
        • Investigative Site PL008
      • Krakow, Poland, 31-501
        • Not yet recruiting
        • Investigative Site PL003
      • Warsaw, Poland, 01-748
        • Not yet recruiting
        • Investigative Site PL007
      • Warsaw, Poland, 02-507
        • Not yet recruiting
        • Investigative Site PL002
      • Warsaw, Poland, 02-034
        • Not yet recruiting
        • Investigative Site PL001
      • Wroclaw, Poland, 53-439
        • Not yet recruiting
        • Investigative Site PL004
  • Puerto Rico
      • Dorado, Puerto Rico, 00646
        • Recruiting
        • Investigative Site PR001
  • South Korea
      • Goyang-si, South Korea, 10408
        • Not yet recruiting
        • Investigative Site KR004
      • Seongnam, South Korea, 13620
        • Not yet recruiting
        • Investigative Site KR005
      • Seongnam-si, South Korea, 13496
        • Not yet recruiting
        • Investigative Site KR007
      • Seoul, South Korea, 03080
        • Not yet recruiting
        • Investigative Site KR002
      • Seoul, South Korea, 03722
        • Not yet recruiting
        • Investigative Site KR006
      • Seoul, South Korea, 05505
        • Not yet recruiting
        • Investigative Site KR001
      • Seoul, South Korea, 06351
        • Not yet recruiting
        • Investigative Site KR003
      • Seoul, South Korea, 06591
        • Not yet recruiting
        • Investigative Site KR008
  • Spain
      • Badalona, Spain, 08916
        • Not yet recruiting
        • Investigative Site ES011
      • Barcelona, Spain, 08035
        • Not yet recruiting
        • Investigative Site ES003
      • Barcelona, Spain, 08036
        • Not yet recruiting
        • Investigative Site ES002
      • Las Palmas de Gran Canaria, Spain, 35016
        • Not yet recruiting
        • Investigative Site ES014
      • Madrid, Spain, 28007
        • Not yet recruiting
        • Investigative Site ES016
      • Madrid, Spain, 28034
        • Not yet recruiting
        • Investigative Site ES006
      • Madrid, Spain, 28040
        • Not yet recruiting
        • Investigative Site ES007
      • Madrid, Spain, 28040
        • Not yet recruiting
        • Investigative Site ES012
      • Madrid, Spain, 28041
        • Not yet recruiting
        • Investigative Site ES008
      • Madrid, Spain, 28050
        • Not yet recruiting
        • Investigative Site ES013
      • Palma de Mallorca, Spain, 07120
        • Not yet recruiting
        • Investigative Site ES005
      • Santander, Spain, 39008
        • Not yet recruiting
        • Investigative Site ES009
      • Seville, Spain, 41009
        • Not yet recruiting
        • Investigative Site ES010
      • Valencia, Spain, 46009
        • Not yet recruiting
        • Investigative Site ES015
      • Valencia, Spain, 46010
        • Not yet recruiting
        • Investigative Site ES017
      • Valencia, Spain, 46014
        • Not yet recruiting
        • Investigative Site ES001
      • Zaragoza, Spain, 50009
        • Not yet recruiting
        • Investigative Site ES004
  • Sweden
      • Linköping, Sweden, 58185
        • Not yet recruiting
        • Investigative Site SE003
      • Malmö, Sweden, 21428
        • Not yet recruiting
        • Investigative Site SE001
      • Solna, Sweden, 171 76
        • Not yet recruiting
        • Investigative Site SE002
  • Switzerland
      • Basel, Switzerland, 04058
        • Not yet recruiting
        • Investigative Site CH005
      • Bern, Switzerland, 03010
        • Not yet recruiting
        • Investigative Site CH003
      • Geneva, Switzerland, 01205
        • Not yet recruiting
        • Investigative Site CH004
      • Lausanne, Switzerland, 01011
        • Not yet recruiting
        • Investigative Site CH002
      • Zurich, Switzerland, 08091
        • Not yet recruiting
        • Investigative Site CH001
  • United Kingdom
      • Dundee, United Kingdom, DD1 9SY
        • Not yet recruiting
        • Investigative Site GB008
      • Guildford, United Kingdom, GU2 7XX
        • Not yet recruiting
        • Investigative Site GB011
      • Headington, United Kingdom, OX3 7LE
        • Not yet recruiting
        • Investigative Site GB002
      • Leeds, United Kingdom, LS9 7TF
        • Not yet recruiting
        • Investigative Site GB001
      • London, United Kingdom, EC1A 7BE
        • Not yet recruiting
        • Investigative Site GB009
      • London, United Kingdom, NW3 2QG
        • Not yet recruiting
        • Investigative Site GB004
      • Manchester, United Kingdom, M20 4BX
        • Not yet recruiting
        • Investigative Site GB003
      • Northwood, United Kingdom, HA6 2RN
        • Not yet recruiting
        • Investigative Site GB010
      • Norwich, United Kingdom, NR4 7UY
        • Not yet recruiting
        • Investigative Site GB005
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Not yet recruiting
        • Investigative Site US058
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Recruiting
        • Investigative Site US016
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Not yet recruiting
        • Investigative Site US026
      • Tucson, Arizona, United States, 85719
        • Not yet recruiting
        • Investigative Site US045
    • California
      • Duarte, California, United States, 91010
        • Not yet recruiting
        • Investigative Site US051
      • Fountain Valley, California, United States, 92708
        • Not yet recruiting
        • Investigative Site US048
      • Irvine, California, United States, 92612
        • Not yet recruiting
        • Investigative Site US049
      • La Jolla, California, United States, 92093
        • Not yet recruiting
        • Investigative Site US054
      • Los Angeles, California, United States, 90033
        • Not yet recruiting
        • Investigative Site US036
      • Los Angeles, California, United States, 90027
        • Not yet recruiting
        • Investigative Site US027
      • San Francisco, California, United States, 94143
        • Not yet recruiting
        • Investigative Site US034
      • Santa Monica, California, United States, 90404
        • Not yet recruiting
        • Investigative Site US001
    • Colorado
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Investigative Site US071
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • Not yet recruiting
        • Investigative Site US013
      • Washington D.C., District of Columbia, United States, 20016
        • Not yet recruiting
        • Investigative Site US046
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Recruiting
        • Investigative Site US072
      • Miami, Florida, United States, 33136
        • Not yet recruiting
        • Investigative Site US075
      • St. Petersburg, Florida, United States, 33701-4553
        • Recruiting
        • Investigative Site US074
      • West Palm Beach, Florida, United States, 33401
        • Recruiting
        • Investigative Site US073
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Not yet recruiting
        • Investigative Site US023
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Not yet recruiting
        • Investigative Site US079
      • Evanston, Illinois, United States, 60201
        • Not yet recruiting
        • Investigative Site US030
      • Naperville, Illinois, United States, 60540
        • Not yet recruiting
        • Investigative Site US005
      • Springfield, Illinois, United States, 62702
        • Recruiting
        • Investigative Site US009
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Not yet recruiting
        • Investigative Site US021
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Not yet recruiting
        • Investigative Site US007
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Not yet recruiting
        • Investigative Site US022
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Not yet recruiting
        • Investigative Site US006
      • Detroit, Michigan, United States, 48201
        • Not yet recruiting
        • Investigative Site US010
      • Grand Rapids, Michigan, United States, 49546
        • Not yet recruiting
        • Investigative Site US078
      • Ypsilanti, Michigan, United States, 48197
        • Not yet recruiting
        • Investigative Site US012
    • Minnesota
      • Maple Grove, Minnesota, United States, 55369
        • Not yet recruiting
        • Investigative Site US066
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • Not yet recruiting
        • Investigative Site US047
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Not yet recruiting
        • Investigative Site US077
      • Morristown, New Jersey, United States, 07960
        • Not yet recruiting
        • Investigative Site US017
    • New York
      • Lake Success, New York, United States, 11042
        • Recruiting
        • Investigative Site US059
      • New York, New York, United States, 10016
        • Not yet recruiting
        • Investigative Site US031
      • New York, New York, United States, 10029
        • Not yet recruiting
        • Investigative Site US041
      • New York, New York, United States, 10032
        • Not yet recruiting
        • Investigative Site US004
      • New York, New York, United States, 10065
        • Not yet recruiting
        • Investigative Site US003
      • The Bronx, New York, United States, 10461
        • Not yet recruiting
        • Investigative Site US029
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Not yet recruiting
        • Investigative Site US035
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Not yet recruiting
        • Investigative Site US050
      • Cleveland, Ohio, United States, 44195
        • Not yet recruiting
        • Investigative Site US020
      • Columbus, Ohio, United States, 43210
        • Not yet recruiting
        • Investigative Site US033
    • Oregon
      • Portland, Oregon, United States, 97239
        • Not yet recruiting
        • Investigative Site US042
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Not yet recruiting
        • Investigative Site US008
      • Philadelphia, Pennsylvania, United States, 19107
        • Not yet recruiting
        • Investigative Site US043
      • Pittsburgh, Pennsylvania, United States, 15212
        • Not yet recruiting
        • Investigative Site US056
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Not yet recruiting
        • Investigative Site US082
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Not yet recruiting
        • Investigative Site US055
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Not yet recruiting
        • Investigative Site US039
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Investigative Site US060
      • Nashville, Tennessee, United States, 37232
        • Not yet recruiting
        • Investigative Site US070
    • Texas
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Investigative Site US067
      • Denison, Texas, United States, 75020
        • Recruiting
        • Investigative Site US062
      • Houston, Texas, United States, 77030
        • Not yet recruiting
        • Investigative Site US011
      • Houston, Texas, United States, 77030
        • Not yet recruiting
        • Investigative Site US018
      • San Antonio, Texas, United States, 78240
        • Recruiting
        • Investigative Site US063
      • San Antonio, Texas, United States, 78229
        • Not yet recruiting
        • Investigative Site US080
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Not yet recruiting
        • Investigative Site US053
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Not yet recruiting
        • Investigative Site US076
      • Fairfax, Virginia, United States, 22031
        • Not yet recruiting
        • Investigative Site US057
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Investigative Site US065
      • Salem, Virginia, United States, 24153
        • Recruiting
        • Investigative Site US064
    • Washington
      • Olympia, Washington, United States, 98506
        • Not yet recruiting
        • Investigative Site US081
      • Seattle, Washington, United States, 98122
        • Not yet recruiting
        • Investigative Site US032
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Not yet recruiting
        • Investigative Site US044

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: INCB161734 plus chemotherapy
INCB161734 at the protocol-defined dose with investigator's choice of chemotherapy (mFOLFIRINOX or GemNabP) in accordance with the protocol-defined requirements.
Drug: 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:
Other Names:
  • mFOLFIRINOX
  • GemNabP
Drug: INCB161734
Oral; tablet
Experimental: Placebo plus chemotherapy
Placebo at the protocol-defined dose with investigator's choice of chemotherapy (mFOLFIRINOX or GemNabP) in accordance with the protocol-defined requirements.
Drug: 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:
Other Names:
  • mFOLFIRINOX
  • GemNabP
Drug: Placebo
Oral; tablet

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Up to approximately 3 years
Defined as the time from the date of randomization to the date of death due to any cause.
Up to approximately 3 years
Progression-free survival (PFS) by BICR
Time Frame: Up to approximately 2 years
Defined as the time from the date of randomization to the date of the first documented progression as determined by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death due to any cause.
Up to approximately 2 years
Objective Response by BICR
Time Frame: Up to approximately 2 years
Defined as complete response (CR) or partial response (PR) as determined by BICR per RECIST v1.1.
Up to approximately 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Duration of Response (DOR) by BICR
Time Frame: Up to approximately 2 years
Defined as the time from the earliest date of documented response until the earliest date of disease progression as determined by BICR per RECIST v1.1 or death from any cause.
Up to approximately 2 years
Disease control by BICR
Time Frame: Up to approximately 2 years
Defined as having CR, PR, or stable disease (SD) as the best response determined by BICR per RECIST v1.1.
Up to approximately 2 years
Progression-Free Survival (PFS) by investigator assessment
Time Frame: Up to approximately 2 years
Defined as the time from the date of randomization to the date of the first documented progression as determined by the investigator per RECIST v1.1 or death due to any cause.
Up to approximately 2 years
Objective response by investigator assessment
Time Frame: Up to approximately 2 years
Defined as CR or PR as determined by the investigator per RECIST v1.1.
Up to approximately 2 years
DOR by investigator assessment
Time Frame: Up to approximately 2 years
Defined as the time from the earliest date of documented response until earliest date of disease progression as determined by the investigator per RECIST v1.1 or death from any cause.
Up to approximately 2 years
Disease control by investigator assessment
Time Frame: Up to approximately 2 years
Defined as having CR, PR, or SD as the best response as determined by the investigator per RECIST v1.1.
Up to approximately 2 years
Treatment Emergent Adverse Events (TEAEs)
Time Frame: Up to approximately 2 years and 30 days
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug until 30 days after the last dose of study drug or the start of new anticancer therapy, whichever occurs first.
Up to approximately 2 years and 30 days
TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatment
Time Frame: Up to approximately 2 years and 30 days
TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatment.
Up to approximately 2 years and 30 days
Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-Core 30 (C30) at each postbaseline visit
Time Frame: Up to approximately 2 years
The EORTC QLQ-C30 is a validated, self-administered questionnaire developed to assess the quality of life in cancer patients. It consists of 30 questions divided into several subscales, including 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, nausea and vomiting, and pain), a global health status/QoL scale, and a number of single-item measures that assess additional symptoms such as dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties.
Up to approximately 2 years
Change from baseline in EORTC QLQ-PAN26 score at each postbaseline visit
Time Frame: Up to approximately 2 years
The EORTC QLQ-PAN26 consists of 26 questions that assess 9 pancreatic cancer-related and treatment-related symptoms (pain, eating-related items, cachexia, hepatic symptoms, side effects, altered bowel habits, ascites, indigestion, and flatulence) and 5 emotional domains specific to pancreatic cancer (body image, healthcare satisfaction, sexuality, fear of future health, and ability to plan for the future). The QLQ-PAN26 is scored on a 4-point scale that ranges from not at all to very much.
Up to approximately 2 years
Change from baseline in EQ-5D-5L score at each postbaseline visit
Time Frame: Up to approximately 2 years
The EQ-5D-5L is a validated, self-reported instrument for assessing HRQoL across 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 response levels of severity, ranging from no problems to extreme problems. The questionnaire also includes a visual analog scale for self-rated overall health on a scale from 0 (worst imaginable health) to 100 (best imaginable health).
Up to approximately 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Incyte Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Incyte Medical Monitor, Incyte Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 9, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 15, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 19, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 3, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • INCB161734-303

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

IPD Sharing Time Frame

Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.

IPD Sharing Access Criteria

Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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