What this study is
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).
What's being tested
- INCB161734
Intervention · DRUG
- Placebo
Intervention · DRUG
- Investigator's choice of chemotherapy
Intervention · DRUG
The investigator will select the chemotherapy in accordance with the protocol-defined requirements. The possible choices as defined by the protocol:
Both INCB161734 and Placebo
Oral; tablet
Study details
- Official title
- A Randomized, Double-Blind, Phase 3 Study of Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma (DAWN-303)
- Sponsor
- Incyte Corporation
- Conditions
- Solid Tumors
- Enrolling
- 588 people
- Starts
- 2026-04-09
- Est. completion
- 2029-03-19
- Design
- Double-blind, randomized, parallel groups, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (230)
229 openInvestigative Site US058
Birmingham, Alabama, United States
Not yet recruitingInvestigative Site US016
Anchorage, Alaska, United States
RecruitingInvestigative Site US026
Chandler, Arizona, United States
RecruitingInvestigative Site US045
Tucson, Arizona, United States
Not yet recruitingInvestigative Site US051
Duarte, California, United States
RecruitingInvestigative Site US085
Fullerton, California, United States
Not yet recruitingInvestigative Site US054
La Jolla, California, United States
Not yet recruitingInvestigative Site US086
Long Beach, California, United States
Not yet recruitingInvestigative Site US027
Los Angeles, California, United States
RecruitingInvestigative Site US036
Los Angeles, California, United States
RecruitingInvestigative Site US048
Los Angeles, California, United States
RecruitingInvestigative Site US049
Orange, California, United States
RecruitingInvestigative Site US034
San Francisco, California, United States
RecruitingInvestigative Site US001
Santa Monica, California, United States
RecruitingInvestigative Site US071
Denver, Colorado, United States
RecruitingInvestigative Site US013
Washington D.C., District of Columbia, United States
Not yet recruitingInvestigative Site US046
Washington D.C., District of Columbia, United States
Not yet recruitingInvestigative Site US072
Fort Myers, Florida, United States
RecruitingInvestigative Site US083
Jacksonville, Florida, United States
Not yet recruitingInvestigative Site US075
Miami, Florida, United States
RecruitingInvestigative Site US074
St. Petersburg, Florida, United States
RecruitingInvestigative Site US073
West Palm Beach, Florida, United States
RecruitingInvestigative Site US023
Atlanta, Georgia, United States
RecruitingInvestigative Site US079
Chicago, Illinois, United States
Not yet recruitingInvestigative Site US030
Evanston, Illinois, United States
RecruitingInvestigative Site US005
Naperville, Illinois, United States
RecruitingInvestigative Site US009
Springfield, Illinois, United States
RecruitingInvestigative Site US021
Indianapolis, Indiana, United States
Not yet recruitingInvestigative Site US007
New Orleans, Louisiana, United States
RecruitingInvestigative Site US022
Boston, Massachusetts, United States
RecruitingInvestigative Site US006
Ann Arbor, Michigan, United States
Not yet recruitingInvestigative Site US010
Detroit, Michigan, United States
RecruitingInvestigative Site US078
Grand Rapids, Michigan, United States
RecruitingInvestigative Site US012
Ypsilanti, Michigan, United States
Not yet recruitingInvestigative Site US066
Maple Grove, Minnesota, United States
RecruitingInvestigative Site US047
Hattiesburg, Mississippi, United States
Not yet recruitingInvestigative Site US084
Reno, Nevada, United States
Not yet recruitingInvestigative Site US077
Hackensack, New Jersey, United States
RecruitingInvestigative Site US017
Morristown, New Jersey, United States
RecruitingInvestigative Site US059
Lake Success, New York, United States
RecruitingInvestigative Site US031
New York, New York, United States
RecruitingInvestigative Site US003
New York, New York, United States
RecruitingInvestigative Site US041
New York, New York, United States
RecruitingInvestigative Site US029
The Bronx, New York, United States
RecruitingInvestigative Site US035
Chapel Hill, North Carolina, United States
RecruitingInvestigative Site US050
Cleveland, Ohio, United States
RecruitingInvestigative Site US020
Cleveland, Ohio, United States
RecruitingInvestigative Site US033
Columbus, Ohio, United States
Not yet recruitingInvestigative Site US042
Portland, Oregon, United States
Not yet recruitingInvestigative Site US008
Philadelphia, Pennsylvania, United States
RecruitingInvestigative Site US043
Philadelphia, Pennsylvania, United States
RecruitingInvestigative Site US056
Pittsburgh, Pennsylvania, United States
RecruitingInvestigative Site US082
Charleston, South Carolina, United States
Not yet recruitingInvestigative Site US055
Sioux Falls, South Dakota, United States
RecruitingInvestigative Site US039
Nashville, Tennessee, United States
RecruitingInvestigative Site US060
Nashville, Tennessee, United States
RecruitingInvestigative Site US070
Nashville, Tennessee, United States
RecruitingInvestigative Site US067
Dallas, Texas, United States
RecruitingInvestigative Site US062
Denison, Texas, United States
RecruitingInvestigative Site US011
Houston, Texas, United States
RecruitingInvestigative Site US080
San Antonio, Texas, United States
Not yet recruitingInvestigative Site US063
San Antonio, Texas, United States
RecruitingInvestigative Site US053
Salt Lake City, Utah, United States
RecruitingInvestigative Site US057
Fairfax, Virginia, United States
Not yet recruitingInvestigative Site US065
Fairfax, Virginia, United States
RecruitingInvestigative Site US064
Salem, Virginia, United States
RecruitingInvestigative Site US081
Olympia, Washington, United States
RecruitingInvestigative Site US032
Seattle, Washington, United States
RecruitingInvestigative Site US044
Madison, Wisconsin, United States
Recruiting
161 sites outside the US
Investigative Site AU011
Macquarie Park, New South Wales, Australia
Not yet recruitingInvestigative Site AU010
Chermside, Queensland, Australia
Not yet recruitingInvestigative Site AU009
Townsville, Queensland, Australia
RecruitingInvestigative Site AU006
Woodville South, South Australia, Australia
RecruitingInvestigative Site AU004
Melbourne, Victoria, Australia
RecruitingInvestigative Site AU001
Melbourne, Victoria, Australia
RecruitingInvestigative Site AU005
Richmond, Victoria, Australia
RecruitingInvestigative Site AU002
Canberra, Australia
Not yet recruitingInvestigative Site AU008
Perth, Australia
RecruitingInvestigative Site AT005
Graz, Austria
Not yet recruitingInvestigative Site AT002
Innsbruck, Austria
RecruitingInvestigative Site AT004
Linz, Austria
RecruitingInvestigative Site AT003
Salzburg, Austria
RecruitingInvestigative Site BE008
Anderlecht, Belgium
Not yet recruitingInvestigative Site BE003
Brussels, Belgium
RecruitingInvestigative Site BE009
Brussels, Belgium
RecruitingInvestigative Site BE001
Edegem, Belgium
RecruitingInvestigative Site BE005
Ghent, Belgium
RecruitingInvestigative Site BE007
Gilly, Belgium
RecruitingInvestigative Site BE004
Leuven, Belgium
RecruitingInvestigative Site BE006
Liège, Belgium
Not yet recruitingInvestigative Site BE002
Yvoir, Belgium
Not yet recruitingInvestigative Site CA007
Hamilton, Ontario, Canada
Not yet recruitingInvestigative Site CA008
Kingston, Ontario, Canada
Not yet recruitingInvestigative Site CA001
Toronto, Ontario, Canada
RecruitingInvestigative Site CA006
Montreal, Quebec, Canada
RecruitingInvestigative Site CA004
Québec, Quebec, Canada
RecruitingInvestigative Site DK006
Aalborg, Denmark
Not yet recruitingInvestigative Site DK005
Århus N, Denmark
RecruitingInvestigative Site DK001
Herlev, Denmark
Not yet recruitingInvestigative Site DK003
Køge, Denmark
Not yet recruitingInvestigative Site DK004
Odense C, Denmark
Not yet recruitingInvestigative Site DK002
Vejle, Denmark
Not yet recruitingInvestigative Site FI001
HUS, Finland
RecruitingInvestigative Site FI003
Tampere, Finland
RecruitingInvestigative Site FI002
Turku, Finland
Not yet recruitingInvestigative Site FR013
Brest, France
Not yet recruitingInvestigative Site FR014
Dijon, France
Not yet recruitingInvestigative Site FR002
Lille, France
Not yet recruitingInvestigative Site FR011
Lyon, France
Not yet recruitingInvestigative Site FR016
Lyon, France
Not yet recruitingInvestigative Site FR006
Marseille, France
Not yet recruitingInvestigative Site FR015
Montpellier, France
Not yet recruitingInvestigative Site FR003
Paris, France
Not yet recruitingInvestigative Site FR009
Paris, France
Not yet recruitingInvestigative Site FR004
Pessac, France
Not yet recruitingInvestigative Site FR008
Poitiers, France
Not yet recruitingInvestigative Site FR010
Reims, France
RecruitingInvestigative Site FR005
Rennes, France
RecruitingInvestigative Site FR007
Toulouse, France
Not yet recruitingInvestigative Site FR012
Tours, France
Not yet recruitingInvestigative Site FR001
Villejuif, France
Not yet recruitingInvestigative Site GE004
Batumi, Georgia
Not yet recruitingInvestigative Site GE002
Marneuli, Georgia
Not yet recruitingInvestigative Site GE005
Tbilisi, Georgia
Not yet recruitingInvestigative Site GE006
Tbilisi, Georgia
Not yet recruitingInvestigative Site GE001
Tbilisi, Georgia
Not yet recruitingInvestigative Site GE003
Tbilisi, Georgia
Not yet recruitingInvestigative Site DE018
Berlin, Germany
Not yet recruitingInvestigative Site DE020
Berlin, Germany
RecruitingInvestigative Site DE003
Bochum, Germany
RecruitingInvestigative Site DE019
Bonn, Germany
Not yet recruitingInvestigative Site DE008
Cologne, Germany
RecruitingInvestigative Site DE001
Dresden, Germany
Not yet recruitingInvestigative Site DE013
Düsseldorf, Germany
Not yet recruitingInvestigative Site DE004
Essen, Germany
RecruitingInvestigative Site DE005
Frankfurt, Germany
RecruitingInvestigative Site DE016
Freiburg im Breisgau, Germany
RecruitingInvestigative Site DE017
Göttingen, Germany
Not yet recruitingInvestigative Site DE002
Halle, Germany
Not yet recruitingInvestigative Site DE007
Hamburg, Germany
RecruitingInvestigative Site DE006
Hamburg, Germany
RecruitingInvestigative Site DE009
Leipzig, Germany
Not yet recruitingInvestigative Site DE015
Munich, Germany
Not yet recruitingInvestigative Site DE014
München, Germany
RecruitingInvestigative Site DE010
Nuremberg, Germany
RecruitingInvestigative Site DE011
Ulm, Germany
RecruitingInvestigative Site IT002
Bologna, Italy
Not yet recruitingInvestigative Site IT010
Brescia, Italy
RecruitingInvestigative Site IT009
Candiolo, Italy
RecruitingInvestigative Site IT012
Foggia, Italy
Not yet recruitingInvestigative Site IT006
Milan, Italy
RecruitingInvestigative Site IT008
Milan, Italy
Not yet recruitingInvestigative Site IT011
Naples, Italy
Not yet recruitingInvestigative Site IT003
Pisa, Italy
Not yet recruitingInvestigative Site IT004
Roma, Italy
RecruitingInvestigative Site IT005
Rome, Italy
Not yet recruitingInvestigative Site IT001
Rozzano, Italy
RecruitingInvestigative Site IT007
Verona, Italy
RecruitingInvestigative Site JP012
Fukuoka Fukuoka, Japan
Not yet recruitingInvestigative Site JP010
Kahoku-gun, Japan
RecruitingInvestigative Site JP014
Kitaadachi-gun, Japan
Not yet recruitingInvestigative Site JP003
Kōtoku, Japan
RecruitingInvestigative Site JP007
Mitaka-shi, Japan
RecruitingInvestigative Site JP004
Osaka, Japan
RecruitingInvestigative Site JP011
Sapporo Hokkaido, Japan
Not yet recruitingInvestigative Site JP009
Shinjuku-ku, Japan
RecruitingInvestigative Site JP013
Suita, Osaka, Japan
Not yet recruitingInvestigative Site JP006
Toyama, Japan
RecruitingInvestigative Site JP008
Wakayama, Japan
RecruitingInvestigative Site JP001
Yokohama, Japan
RecruitingInvestigative Site NL001
Amsterdam, Netherlands
RecruitingInvestigative Site NL007
Eindhoven, Netherlands
RecruitingInvestigative Site NL005
Groningen, Netherlands
RecruitingInvestigative Site NL003
Maastricht, Netherlands
RecruitingInvestigative Site NL006
Utrecht, Netherlands
RecruitingInvestigative Site NZ001
Auckland, New Zealand
Not yet recruitingInvestigative Site NO002
Bergen, Norway
RecruitingInvestigative Site NO001
Oslo, Norway
RecruitingInvestigative Site NO005
Stavanger, Norway
Not yet recruitingInvestigative Site NO003
Trondheim, Norway
Not yet recruitingInvestigative Site PL008
Gdansk, Poland
Not yet recruitingInvestigative Site PL003
Krakow, Poland
Not yet recruitingInvestigative Site PL007
Warsaw, Poland
RecruitingInvestigative Site PL001
Warsaw, Poland
RecruitingInvestigative Site PL002
Warsaw, Poland
Not yet recruitingInvestigative Site PL004
Wroclaw, Poland
Not yet recruitingInvestigative Site PR001
Dorado, Puerto Rico
RecruitingInvestigative Site KR004
Goyang-si, South Korea
RecruitingInvestigative Site KR007
Seongnam-si, South Korea
RecruitingInvestigative Site KR005
Seongnam-si, South Korea
RecruitingInvestigative Site KR002
Seoul, South Korea
RecruitingInvestigative Site KR006
Seoul, South Korea
RecruitingInvestigative Site KR001
Seoul, South Korea
RecruitingInvestigative Site KR003
Seoul, South Korea
RecruitingInvestigative Site KR008
Seoul, South Korea
Not yet recruitingInvestigative Site ES011
Badalona, Spain
Not yet recruitingInvestigative Site ES002
Barcelona, Spain
RecruitingInvestigative Site ES003
Barcelona, Spain
Not yet recruitingInvestigative Site ES014
Las Palmas de Gran Canaria, Spain
RecruitingInvestigative Site ES016
Madrid, Spain
RecruitingInvestigative Site ES006
Madrid, Spain
Not yet recruitingInvestigative Site ES007
Madrid, Spain
RecruitingInvestigative Site ES012
Madrid, Spain
Not yet recruitingInvestigative Site ES008
Madrid, Spain
RecruitingInvestigative Site ES013
Madrid, Spain
RecruitingInvestigative Site ES005
Palma de Mallorca, Spain
Not yet recruitingInvestigative Site ES009
Santander, Spain
RecruitingInvestigative Site ES010
Seville, Spain
Not yet recruitingInvestigative Site ES015
Valencia, Spain
Not yet recruitingInvestigative Site ES017
Valencia, Spain
Not yet recruitingInvestigative Site ES001
Valencia, Spain
RecruitingInvestigative Site ES004
Zaragoza, Spain
RecruitingInvestigative Site SE003
Linköping, Sweden
Not yet recruitingInvestigative Site SE001
Lund, Sweden
RecruitingInvestigative Site SE002
Stockholm, Sweden
RecruitingInvestigative Site CH005
Basel, Switzerland
RecruitingInvestigative Site CH003
Bern, Switzerland
Not yet recruitingInvestigative Site CH004
Geneva, Switzerland
Not yet recruitingInvestigative Site CH002
Lausanne, Switzerland
RecruitingInvestigative Site CH001
Zurich, Switzerland
RecruitingInvestigative Site GR008
Dundee, United Kingdom
RecruitingInvestigative Site GB011
Guildford, United Kingdom
Not yet recruitingInvestigative Site GB002
Headington, United Kingdom
Not yet recruitingInvestigative Site GB001
Leeds, United Kingdom
Not yet recruitingInvestigative Site GB009
London, United Kingdom
RecruitingInvestigative Site GB004
London, United Kingdom
Not yet recruitingInvestigative Site GB003
Manchester, United Kingdom
Not yet recruitingInvestigative Site GB010
Northwood, United Kingdom
Not yet recruitingInvestigative Site GB005
Norwich, United Kingdom
Not yet recruitingInvestigative Site JP015
Akashi, HYGO, Japan
Active, not recruiting
Study team
Sponsor
Incyte Corporation
Study ID INCB161734-303
Study director
Incyte Medical Monitor
Incyte Corporation
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.