Solid TumorsPhase 3DAWN-303NCT07522073
A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma
A Phase 3 study testing INCB161734 and Investigator's choice of chemotherapy in people with Solid Tumors, run by Incyte Corporation at 230 sites in 22 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- INCB161734 and Investigator's choice of chemotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 588 participants
- Where
- 230 sitesin 22 countries
- Study dates
- 9 Apr 2026to 19 Mar 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
230 sites in 22 countries. Contact the study team or a site near you to ask about taking part.
230 sites in 22 countries
United States69 sites, 69 recruiting
- Recruiting
Investigative Site US016
Anchorage, Alaska, 99508
- Not yet recruiting
Investigative Site US006
Ann Arbor, Michigan, 48109-9001
- Recruiting
Investigative Site US023
Atlanta, Georgia, 30322
- Not yet recruiting
Investigative Site US058
Birmingham, Alabama, 35233
- Recruiting
Investigative Site US022
Boston, Massachusetts, 02215
- Recruiting
Investigative Site US026
Chandler, Arizona, 85224
- Recruiting
Investigative Site US035
Chapel Hill, North Carolina, 27514
- Not yet recruiting
Investigative Site US082
Charleston, South Carolina, 29425
- Not yet recruiting
Investigative Site US079
Chicago, Illinois, 60637
- Recruiting
Investigative Site US050
Cleveland, Ohio, 44106
- Recruiting
Investigative Site US020
Cleveland, Ohio, 44195
- Not yet recruiting
Investigative Site US033
Columbus, Ohio, 43210
- Recruiting
Investigative Site US067
Dallas, Texas, 75246
- Recruiting
Investigative Site US062
Denison, Texas, 75020
- Recruiting
Investigative Site US071
Denver, Colorado, 80218
- Recruiting
Investigative Site US010
Detroit, Michigan, 48201
- Recruiting
Investigative Site US051
Duarte, California, 91010
- Recruiting
Investigative Site US030
Evanston, Illinois, 60201
- Not yet recruiting
Investigative Site US057
Fairfax, Virginia, 22031
- Recruiting
Investigative Site US065
Fairfax, Virginia, 22031
- Recruiting
Investigative Site US072
Fort Myers, Florida, 33901
- Not yet recruiting
Investigative Site US085
Fullerton, California, 92835
- Recruiting
Investigative Site US078
Grand Rapids, Michigan, 49503
- Recruiting
Investigative Site US077
Hackensack, New Jersey, 07601
- Not yet recruiting
Investigative Site US047
Hattiesburg, Mississippi, 39401
- Recruiting
Investigative Site US011
Houston, Texas, 77030
- Not yet recruiting
Investigative Site US021
Indianapolis, Indiana, 46250
- Not yet recruiting
Investigative Site US083
Jacksonville, Florida, 32207
- Not yet recruiting
Investigative Site US054
La Jolla, California, 92093
- Recruiting
Investigative Site US059
Lake Success, New York, 11042
- Not yet recruiting
Investigative Site US086
Long Beach, California, 90806-1650
- Recruiting
Investigative Site US027
Los Angeles, California, 90027
- Recruiting
Investigative Site US036
Los Angeles, California, 90089
- Recruiting
Investigative Site US048
Los Angeles, California, 91204-3640
- Recruiting
Investigative Site US044
Madison, Wisconsin, 53792
- Recruiting
Investigative Site US066
Maple Grove, Minnesota, 55369
- Recruiting
Investigative Site US075
Miami, Florida, 33136
- Recruiting
Investigative Site US017
Morristown, New Jersey, 07960
- Recruiting
Investigative Site US005
Naperville, Illinois, 60540
- Recruiting
Investigative Site US039
Nashville, Tennessee, 37203
- Recruiting
Investigative Site US060
Nashville, Tennessee, 37203
- Recruiting
Investigative Site US070
Nashville, Tennessee, 37232-6309
- Recruiting
Investigative Site US007
New Orleans, Louisiana, 70121
- Recruiting
Investigative Site US031
New York, New York, 10016
- Recruiting
Investigative Site US003
New York, New York, 10065
- Recruiting
Investigative Site US041
New York, New York, 10128
- Recruiting
Investigative Site US081
Olympia, Washington, 98506
- Recruiting
Investigative Site US049
Orange, California, 92868
- Recruiting
Investigative Site US008
Philadelphia, Pennsylvania, 19104
- Recruiting
Investigative Site US043
Philadelphia, Pennsylvania, 19107
- Recruiting
Investigative Site US056
Pittsburgh, Pennsylvania, 15212
- Not yet recruiting
Investigative Site US042
Portland, Oregon, 97239
- Not yet recruiting
Investigative Site US084
Reno, Nevada, 89502
- Recruiting
Investigative Site US064
Salem, Virginia, 24153
- Recruiting
Investigative Site US053
Salt Lake City, Utah, 84112
- Not yet recruiting
Investigative Site US080
San Antonio, Texas, 78229
- Recruiting
Investigative Site US063
San Antonio, Texas, 78240
- Recruiting
Investigative Site US034
San Francisco, California, 94143
- Recruiting
Investigative Site US001
Santa Monica, California, 90404
- Recruiting
Investigative Site US032
Seattle, Washington, 98104
- Recruiting
Investigative Site US055
Sioux Falls, South Dakota, 57105-2140
- Recruiting
Investigative Site US009
Springfield, Illinois, 62702
- Recruiting
Investigative Site US074
St. Petersburg, Florida, 33701-4553
- Recruiting
Investigative Site US029
The Bronx, New York, 10461
- Not yet recruiting
Investigative Site US045
Tucson, Arizona, 85719
- Not yet recruiting
Investigative Site US013
Washington D.C., District of Columbia, 20007
- Not yet recruiting
Investigative Site US046
Washington D.C., District of Columbia, 20016
- Recruiting
Investigative Site US073
West Palm Beach, Florida, 33401
- Not yet recruiting
Investigative Site US012
Ypsilanti, Michigan, 48197
Germany19 sites, 19 recruiting
- Not yet recruiting
Investigative Site DE018
Berlin, 10365
- Recruiting
Investigative Site DE020
Berlin, 13353
- Recruiting
Investigative Site DE003
Bochum, 44791
- Not yet recruiting
Investigative Site DE019
Bonn, 53127
- Recruiting
Investigative Site DE008
Cologne, D-50937
- Not yet recruiting
Investigative Site DE001
Dresden, 01307
- Not yet recruiting
Investigative Site DE013
Düsseldorf, 40225
- Recruiting
Investigative Site DE004
Essen, 45147
- Recruiting
Investigative Site DE005
Frankfurt, 60488
- Recruiting
Investigative Site DE016
Freiburg im Breisgau, 79106
- Not yet recruiting
Investigative Site DE017
Göttingen, 37075
- Not yet recruiting
Investigative Site DE002
Halle, 06120
- Recruiting
Investigative Site DE007
Hamburg, 20251
- Recruiting
Investigative Site DE006
Hamburg, 22763
- Not yet recruiting
Investigative Site DE009
Leipzig, 04103
- Recruiting
Investigative Site DE014
München, 81737
- Not yet recruiting
Investigative Site DE015
Munich, 81377
- Recruiting
Investigative Site DE010
Nuremberg, 90419
- Recruiting
Investigative Site DE011
Ulm, 89081
Spain17 sites, 17 recruiting
- Not yet recruiting
Investigative Site ES011
Badalona, 08916
- Recruiting
Investigative Site ES002
Barcelona, 08011
- Not yet recruiting
Investigative Site ES003
Barcelona, 08035
- Recruiting
Investigative Site ES014
Las Palmas de Gran Canaria, 35016
- Recruiting
Investigative Site ES016
Madrid, 28009
- Not yet recruiting
Investigative Site ES006
Madrid, 28034
- Recruiting
Investigative Site ES007
Madrid, 28040
- Not yet recruiting
Investigative Site ES012
Madrid, 28040
- Recruiting
Investigative Site ES008
Madrid, 28041
- Recruiting
Investigative Site ES013
Madrid, 28050
- Not yet recruiting
Investigative Site ES005
Palma de Mallorca, 07120
- Recruiting
Investigative Site ES009
Santander, 39008
- Not yet recruiting
Investigative Site ES010
Seville, 41009
- Not yet recruiting
Investigative Site ES015
Valencia, 46009
- Not yet recruiting
Investigative Site ES017
Valencia, 46010
- Recruiting
Investigative Site ES001
Valencia, 46014
- Recruiting
Investigative Site ES004
Zaragoza, 50009
France16 sites, 16 recruiting
- Not yet recruiting
Investigative Site FR013
Brest, 29200
- Not yet recruiting
Investigative Site FR014
Dijon, 21000
- Not yet recruiting
Investigative Site FR002
Lille, 59037
- Not yet recruiting
Investigative Site FR011
Lyon, 69008
- Not yet recruiting
Investigative Site FR016
Lyon, 69373
- Not yet recruiting
Investigative Site FR006
Marseille, 13385
- Not yet recruiting
Investigative Site FR015
Montpellier, 34298
- Not yet recruiting
Investigative Site FR003
Paris, 75013
- Not yet recruiting
Investigative Site FR009
Paris, 75015
- Not yet recruiting
Investigative Site FR004
Pessac, 33604
- Not yet recruiting
Investigative Site FR008
Poitiers, 86021
- Recruiting
Investigative Site FR010
Reims, 51100
- Recruiting
Investigative Site FR005
Rennes, 35042
- Not yet recruiting
Investigative Site FR007
Toulouse, 31059
- Not yet recruiting
Investigative Site FR012
Tours, 37000
- Not yet recruiting
Investigative Site FR001
Villejuif, 94805
Japan13 sites, 12 recruiting
- Active, not recruiting
Investigative Site JP015
Akashi, HYGO, 673-0021
- Not yet recruiting
Investigative Site JP012
Fukuoka Fukuoka, 812-0054
- Recruiting
Investigative Site JP010
Kahoku-gun, 920-0293
- Not yet recruiting
Investigative Site JP014
Kitaadachi-gun, 362-0806
- Recruiting
Investigative Site JP003
Kōtoku, 135-8550
- Recruiting
Investigative Site JP007
Mitaka-shi, 181-8611
- Recruiting
Investigative Site JP004
Osaka, 541-8567
- Not yet recruiting
Investigative Site JP011
Sapporo Hokkaido, 060-0814
- Recruiting
Investigative Site JP009
Shinjuku-ku, 160-0023
- Not yet recruiting
Investigative Site JP013
Suita, Osaka, 565-0871
- Recruiting
Investigative Site JP006
Toyama, 930-0194
- Recruiting
Investigative Site JP008
Wakayama, 641-8510
- Recruiting
Investigative Site JP001
Yokohama, 241-8515
Italy12 sites, 12 recruiting
- Not yet recruiting
Investigative Site IT002
Bologna, 40138
- Recruiting
Investigative Site IT010
Brescia, 25124
- Recruiting
Investigative Site IT009
Candiolo, 10060
- Not yet recruiting
Investigative Site IT012
Foggia, 71122
- Recruiting
Investigative Site IT006
Milan, 20132
- Not yet recruiting
Investigative Site IT008
Milan, 20133
- Not yet recruiting
Investigative Site IT011
Naples, 80131
- Not yet recruiting
Investigative Site IT003
Pisa, 56126
- Recruiting
Investigative Site IT004
Roma, 00152
- Not yet recruiting
Investigative Site IT005
Rome, 00138
- Recruiting
Investigative Site IT001
Rozzano, 20089
- Recruiting
Investigative Site IT007
Verona, 37134
Australia9 sites, 9 recruiting
- Not yet recruiting
Investigative Site AU002
Canberra, 02605
- Not yet recruiting
Investigative Site AU010
Chermside, Queensland, 04032
- Not yet recruiting
Investigative Site AU011
Macquarie Park, New South Wales, 02109
- Recruiting
Investigative Site AU004
Melbourne, Victoria, 03000
- Recruiting
Investigative Site AU001
Melbourne, Victoria, 03004
- Recruiting
Investigative Site AU008
Perth, 06009
- Recruiting
Investigative Site AU005
Richmond, Victoria, 03121
- Recruiting
Investigative Site AU009
Townsville, Queensland, 04814
- Recruiting
Investigative Site AU006
Woodville South, South Australia, 05011
Belgium9 sites, 9 recruiting
- Not yet recruiting
Investigative Site BE008
Anderlecht, 01070
- Recruiting
Investigative Site BE003
Brussels, 01090
- Recruiting
Investigative Site BE009
Brussels, 01200
- Recruiting
Investigative Site BE001
Edegem, 02650
- Recruiting
Investigative Site BE005
Ghent, 09000
- Recruiting
Investigative Site BE007
Gilly, 06060
- Recruiting
Investigative Site BE004
Leuven, 03000
- Not yet recruiting
Investigative Site BE006
Liège, 04000
- Not yet recruiting
Investigative Site BE002
Yvoir, 05530
United Kingdom9 sites, 9 recruiting
- Recruiting
Investigative Site GR008
Dundee, DD1 9SY
- Not yet recruiting
Investigative Site GB011
Guildford, GU2 7XX
- Not yet recruiting
Investigative Site GB002
Headington, OX3 7LE
- Not yet recruiting
Investigative Site GB001
Leeds, LS9 7TF
- Recruiting
Investigative Site GB009
London, EC1A 7BE
- Not yet recruiting
Investigative Site GB004
London, NW3 2QG
- Not yet recruiting
Investigative Site GB003
Manchester, M20 4BX
- Not yet recruiting
Investigative Site GB010
Northwood, HA6 2RN
- Not yet recruiting
Investigative Site GB005
Norwich, NR4 7UY
South Korea8 sites, 8 recruiting
- Recruiting
Investigative Site KR004
Goyang-si, 10408
- Recruiting
Investigative Site KR007
Seongnam-si, 13496
- Recruiting
Investigative Site KR005
Seongnam-si, 13620
- Recruiting
Investigative Site KR002
Seoul, 03080
- Recruiting
Investigative Site KR006
Seoul, 03722
- Recruiting
Investigative Site KR001
Seoul, 05505
- Recruiting
Investigative Site KR003
Seoul, 06351
- Not yet recruiting
Investigative Site KR008
Seoul, 06591
Denmark6 sites, 6 recruiting
- Not yet recruiting
Investigative Site DK006
Aalborg, 09000
- Recruiting
Investigative Site DK005
Århus N, 08200
- Not yet recruiting
Investigative Site DK001
Herlev, 02730
- Not yet recruiting
Investigative Site DK003
Køge, 04600
- Not yet recruiting
Investigative Site DK004
Odense C, 05000
- Not yet recruiting
Investigative Site DK002
Vejle, 07100
Georgia6 sites, 6 recruiting
- Not yet recruiting
Investigative Site GE004
Batumi, 06004
- Not yet recruiting
Investigative Site GE002
Marneuli, 03000
- Not yet recruiting
Investigative Site GE005
Tbilisi, 00112
- Not yet recruiting
Investigative Site GE006
Tbilisi, 00159
- Not yet recruiting
Investigative Site GE001
Tbilisi, 00186
- Not yet recruiting
Investigative Site GE003
Tbilisi, 00186
Poland6 sites, 6 recruiting
- Not yet recruiting
Investigative Site PL008
Gdansk, 80-214
- Not yet recruiting
Investigative Site PL003
Krakow, 31-501
- Recruiting
Investigative Site PL007
Warsaw, 01-748
- Recruiting
Investigative Site PL001
Warsaw, 02-034
- Not yet recruiting
Investigative Site PL002
Warsaw, 02-507
- Not yet recruiting
Investigative Site PL004
Wroclaw, 53-439
Canada5 sites, 5 recruiting
- Not yet recruiting
Investigative Site CA007
Hamilton, Ontario, L8V5C2
- Not yet recruiting
Investigative Site CA008
Kingston, Ontario, K7L 5P9
- Recruiting
Investigative Site CA006
Montreal, Quebec, H4A 3J1
- Recruiting
Investigative Site CA004
Québec, Quebec, G1J 1Z4
- Recruiting
Investigative Site CA001
Toronto, Ontario, M5G 2M9
Netherlands5 sites, 5 recruiting
- Recruiting
Investigative Site NL001
Amsterdam, 1081 HV
- Recruiting
Investigative Site NL007
Eindhoven, 5623 EJ
- Recruiting
Investigative Site NL005
Groningen, 9700 RB
- Recruiting
Investigative Site NL003
Maastricht, 6229 HX
- Recruiting
Investigative Site NL006
Utrecht, 3543 AZ
Switzerland5 sites, 5 recruiting
- Recruiting
Investigative Site CH005
Basel, 04058
- Not yet recruiting
Investigative Site CH003
Bern, 03010
- Not yet recruiting
Investigative Site CH004
Geneva, 01205
- Recruiting
Investigative Site CH002
Lausanne, 01011
- Recruiting
Investigative Site CH001
Zurich, 08091
Austria4 sites, 4 recruiting
- Not yet recruiting
Investigative Site AT005
Graz, 8036
- Recruiting
Investigative Site AT002
Innsbruck, 06020
- Recruiting
Investigative Site AT004
Linz, 04010
- Recruiting
Investigative Site AT003
Salzburg, 05020
Norway4 sites, 4 recruiting
- Recruiting
Investigative Site NO002
Bergen, 05021
- Recruiting
Investigative Site NO001
Oslo, 00379
- Not yet recruiting
Investigative Site NO005
Stavanger, 04011
- Not yet recruiting
Investigative Site NO003
Trondheim, 07030
Finland3 sites, 3 recruiting
- Recruiting
Investigative Site FI001
HUS, 00290
- Recruiting
Investigative Site FI003
Tampere, 33521
- Not yet recruiting
Investigative Site FI002
Turku, 20521
Sweden3 sites, 3 recruiting
- Not yet recruiting
Investigative Site SE003
Linköping, 58185
- Recruiting
Investigative Site SE001
Lund, 222 42
- Recruiting
Investigative Site SE002
Stockholm, 17176
New Zealand1 site, 1 recruiting
- Not yet recruiting
Investigative Site NZ001
Auckland, 01023
Puerto Rico1 site, 1 recruiting
- Recruiting
Investigative Site PR001
Dorado, 00646
About this study
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)
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).
- Conditions
- Solid Tumors
- Being tested
- INCB161734, Placebo, Investigator's choice of chemotherapy
- Keywords
- INCB161734, KRASG12D Mutation, pancreatic ductal adenocarcinoma (PDAC), KRAS G12D inhibitor, KRAS inhibitor, KRAS mutation, pancreatic cancer, metastatic pancreatic cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCB161734Drug
Oral; tablet
PlaceboDrug
Oral; tablet
Investigator's choice of chemotherapyDrug
Also called mFOLFIRINOX, GemNabP
The investigator will select the chemotherapy in accordance with the protocol-defined requirements. The possible choices as defined by the protocol:
| Study group | Role | What they receive |
|---|---|---|
| INCB161734 plus chemotherapy | Experimental | INCB161734 at the protocol-defined dose with investigator's choice of chemotherapy (mFOLFIRINOX or GemNabP) in accordance with the protocol-defined requirements. Receives: Drug: INCB161734; Drug: Investigator's choice of chemotherapy |
| Placebo plus chemotherapy | Experimental | Placebo at the protocol-defined dose with investigator's choice of chemotherapy (mFOLFIRINOX or GemNabP) in accordance with the protocol-defined requirements. Receives: Drug: Placebo; Drug: Investigator's choice of chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Defined as the time from the date of randomization to the date of death due to any cause.
Measured: Up to approximately 3 years
Progression-free survival (PFS) by BICR
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.
Measured: Up to approximately 2 years
Objective Response by BICR
Defined as complete response (CR) or partial response (PR) as determined by BICR per RECIST v1.1.
Measured: Up to approximately 2 years
Secondary outcomes (11)
Duration of Response (DOR) by BICR
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.
Measured: Up to approximately 2 years
Disease control by BICR
Defined as having CR, PR, or stable disease (SD) as the best response determined by BICR per RECIST v1.1.
Measured: Up to approximately 2 years
Progression-Free Survival (PFS) by investigator assessment
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.
Measured: Up to approximately 2 years
Objective response by investigator assessment
Defined as CR or PR as determined by the investigator per RECIST v1.1.
Measured: Up to approximately 2 years
DOR by investigator assessment
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.
Measured: Up to approximately 2 years
Disease control by investigator assessment
Defined as having CR, PR, or SD as the best response as determined by the investigator per RECIST v1.1.
Measured: Up to approximately 2 years
Treatment Emergent Adverse Events (TEAEs)
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.
Measured: Up to approximately 2 years and 30 days
TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatment
TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatment.
Measured: 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
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.
Measured: Up to approximately 2 years
Change from baseline in EORTC QLQ-PAN26 score at each postbaseline visit
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.
Measured: Up to approximately 2 years
Change from baseline in EQ-5D-5L score at each postbaseline visit
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).
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start9 Apr 2026
- Primary completion15 Sep 2028 (estimated)
- Study completion19 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 588 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Qiagen Manchester Ltd
- Responsible party
- Sponsor
- Investigators
- Incyte Medical Monitor, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07522073
- Sponsor's protocol ID
- INCB161734-303
- Acronym
- DAWN-303
- Status last verified
- Oct 2026
- First submitted
- 3 Apr 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07522073
- Acronym / sponsor ID
- DAWN-303 / INCB161734-303
- Conditions
- Solid Tumors
- Keywords
- INCB161734, KRASG12D Mutation, pancreatic ductal adenocarcinoma (PDAC), KRAS G12D inhibitor, KRAS inhibitor, KRAS mutation, pancreatic cancer, metastatic pancreatic cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 588 participants (estimated)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Qiagen Manchester Ltd
- Study start
- 9 Apr 2026 (actual)
- Primary completion
- 15 Sep 2028 (estimated)
- Study completion
- 19 Mar 2029 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INCB161734 plus chemotherapy | Experimental | Drug: INCB161734, Drug: Investigator's choice of chemotherapyINCB161734 at the protocol-defined dose with investigator's choice of chemotherapy (mFOLFIRINOX or GemNabP) in accordance with the protocol-defined requirements. |
| Placebo plus chemotherapy | Experimental | Drug: Placebo, Drug: Investigator's choice of chemotherapyPlacebo at the protocol-defined dose with investigator's choice of chemotherapy (mFOLFIRINOX or GemNabP) in accordance with the protocol-defined requirements. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INCB161734Oral; tablet | Drug | INCB161734 plus chemotherapy |
| PlaceboOral; tablet | Drug | Placebo plus chemotherapy |
| Investigator's choice of chemotherapyAlso: mFOLFIRINOX, GemNabPThe investigator will select the chemotherapy in accordance with the protocol-defined requirements. The possible choices as defined by the protocol: | Drug | INCB161734 plus chemotherapy, Placebo plus chemotherapy |
Primary outcome
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.
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.
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.
11 secondary outcomes
Duration of Response (DOR) by BICR
Time frame: Up to approximately 2 years
Disease control by BICR
Time frame: Up to approximately 2 years
Progression-Free Survival (PFS) by investigator assessment
Time frame: Up to approximately 2 years
Objective response by investigator assessment
Time frame: Up to approximately 2 years
DOR by investigator assessment
Time frame: Up to approximately 2 years
Disease control by investigator assessment
Time frame: Up to approximately 2 years
Treatment Emergent Adverse Events (TEAEs)
Time frame: 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
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
Change from baseline in EORTC QLQ-PAN26 score at each postbaseline visit
Time frame: Up to approximately 2 years
Change from baseline in EQ-5D-5L score at each postbaseline visit
Time frame: Up to approximately 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal AdenocarcinomaLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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
Related trials for Solid Tumors
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 1
A Study of MGC030 in Participants With Advanced Solid Tumors
Urothelial Cancer, GastroEsophageal Cancer
RecruitingPhase 1
SW-682 in Advanced Solid Tumors
Advanced Solid Tumor, Mesothelioma, Malignant
RecruitingPhase 1
Study to Evaluate CD8 PET Imaging as a Marker of Immune Response to Stereotactic Body Radiation Therapy (ELIXR)
Metastatic Malignant Solid Neoplasm, Lymphoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Incyte Medical Monitor study director
Incyte Corporation
230 sites in 22 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing INCB161734 and Investigator's choice of chemotherapy in people with Solid Tumors, run by Incyte Corporation at 230 sites in 22 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 230 sites in United States, Germany, Spain, France, Japan and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Incyte Corporation Call Center (US) (1.855.463.3463, medinfo@incyte.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: Up to approximately 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.