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

NCT07522073 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: INCB161734-303
• Study Type: interventional
• Target: 588
• Locations: 19 countries
• Sites: 204

Brief 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).

Conditions

Solid Tumors

Keywords

INCB161734; KRASG12D Mutation; pancreatic ductal adenocarcinoma (PDAC); KRAS G12D inhibitor; KRAS inhibitor; KRAS mutation; pancreatic cancer; metastatic pancreatic cancer

Outcome Measures

Primary Outcomes (3)

• Overall Survival (OS)

  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

  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

  Defined as complete response (CR) or partial response (PR) as determined by BICR per RECIST v1.1.

  Up to approximately 2 years

Secondary Outcomes (11)

• Duration of Response (DOR) by BICR

  Up to approximately 2 years

• Disease control by BICR

  Up to approximately 2 years

• Progression-Free Survival (PFS) by investigator assessment

  Up to approximately 2 years

• Objective response by investigator assessment

  Up to approximately 2 years

• DOR by investigator assessment

  Up to approximately 2 years

Study Arms (2)

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.

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.

Drug: Placebo; Drug: Investigator's choice of chemotherapy

Interventions

INCB161734 DRUG

Oral; tablet

INCB161734 plus chemotherapy

Placebo DRUG

Oral; tablet

Placebo plus chemotherapy

Investigator's choice of chemotherapy DRUG

The investigator will select the chemotherapy in accordance with the protocol-defined requirements. The possible choices as defined by the protocol:

Also known as: mFOLFIRINOX, GemNabP

INCB161734 plus chemotherapy; Placebo plus chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You 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 may not qualify 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

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (212)

Investigative Site US058

Birmingham, Alabama, 35233, United States

NOT YET RECRUITING

Investigative Site US016

Anchorage, Alaska, 99508, United States

NOT YET RECRUITING

Investigative Site US026

Chandler, Arizona, 85224, United States

NOT YET RECRUITING

Investigative Site US045

Tucson, Arizona, 85719, United States

NOT YET RECRUITING

Investigative Site US051

Duarte, California, 91010, United States

NOT YET RECRUITING

Investigative Site US048

Fountain Valley, California, 92708, United States

NOT YET RECRUITING

Investigative Site US049

Irvine, California, 92612, United States

NOT YET RECRUITING

Investigative Site US054

La Jolla, California, 92093, United States

NOT YET RECRUITING

Investigative Site US027

Los Angeles, California, 90027, United States

NOT YET RECRUITING

Investigative Site US036

Los Angeles, California, 90033, United States

NOT YET RECRUITING

Investigative Site US019

Los Angeles, California, 90048, United States

NOT YET RECRUITING

Investigative Site US034

San Francisco, California, 94143, United States

NOT YET RECRUITING

Investigative Site US001

Santa Monica, California, 90404, United States

NOT YET RECRUITING

Investigative Site US071

Denver, Colorado, 80218, United States

NOT YET RECRUITING

Investigative Site US013

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

NOT YET RECRUITING

Investigative Site US046

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

NOT YET RECRUITING

Investigative Site US072

Fort Myers, Florida, 33901, United States

NOT YET RECRUITING

Investigative Site US075

Miami, Florida, 33136, United States

NOT YET RECRUITING

Investigative Site US073

West Palm Beach, Florida, 33401, United States

NOT YET RECRUITING

Investigative Site US074

Winter Park, Florida, 32789, United States

NOT YET RECRUITING

Investigative Site US023

Atlanta, Georgia, 30322, United States

NOT YET RECRUITING

Investigative Site US079

Chicago, Illinois, 60637, United States

NOT YET RECRUITING

Investigative Site US030

Evanston, Illinois, 60201, United States

NOT YET RECRUITING

Investigative Site US005

Naperville, Illinois, 60540, United States

NOT YET RECRUITING

Investigative Site US009

Springfield, Illinois, 62702, United States

NOT YET RECRUITING

Investigative Site US021

Indianapolis, Indiana, 46219, United States

NOT YET RECRUITING

Investigative Site US007

New Orleans, Louisiana, 70121, United States

NOT YET RECRUITING

Investigative Site US022

Boston, Massachusetts, 02215, United States

NOT YET RECRUITING

Investigative Site US006

Ann Arbor, Michigan, 48109, United States

NOT YET RECRUITING

Investigative Site US010

Detroit, Michigan, 48201, United States

NOT YET RECRUITING

Investigative Site US078

Grand Rapids, Michigan, 49546, United States

NOT YET RECRUITING

Investigative Site US012

Ypsilanti, Michigan, 48197, United States

NOT YET RECRUITING

Investigative Site US066

Maple Grove, Minnesota, 55369, United States

NOT YET RECRUITING

Investigative Site US047

Hattiesburg, Mississippi, 39401, United States

NOT YET RECRUITING

Investigative Site US077

Hackensack, New Jersey, 07601, United States

NOT YET RECRUITING

Investigative Site US017

Morristown, New Jersey, 07960, United States

NOT YET RECRUITING

Investigative Site US059

Lake Success, New York, 11042, United States

RECRUITING

Investigative Site US031

New York, New York, 10016, United States

NOT YET RECRUITING

Investigative Site US041

New York, New York, 10029, United States

NOT YET RECRUITING

Investigative Site US004

New York, New York, 10032, United States

NOT YET RECRUITING

Investigative Site US003

New York, New York, 10065, United States

NOT YET RECRUITING

Investigative Site US029

The Bronx, New York, 10461, United States

NOT YET RECRUITING

Investigative Site US035

Chapel Hill, North Carolina, 27514, United States

NOT YET RECRUITING

Investigative Site US050

Cleveland, Ohio, 44106, United States

NOT YET RECRUITING

Investigative Site US020

Cleveland, Ohio, 44195, United States

NOT YET RECRUITING

Investigative Site US033

Columbus, Ohio, 43210, United States

NOT YET RECRUITING

Investigative Site US042

Portland, Oregon, 97239, United States

NOT YET RECRUITING

Investigative Site US008

Philadelphia, Pennsylvania, 19104, United States

NOT YET RECRUITING

Investigative Site US043

Philadelphia, Pennsylvania, 19107, United States

NOT YET RECRUITING

Investigative Site US056

Pittsburgh, Pennsylvania, 15212, United States

NOT YET RECRUITING

Investigative Site US055

Sioux Falls, South Dakota, 57105, United States

NOT YET RECRUITING

Investigative Site US039

Nashville, Tennessee, 37203, United States

NOT YET RECRUITING

Investigative Site US060

Nashville, Tennessee, 37203, United States

RECRUITING

Investigative Site US070

Nashville, Tennessee, 37232, United States

NOT YET RECRUITING

Investigative Site US067

Dallas, Texas, 75246, United States

RECRUITING

Investigative Site US062

Denison, Texas, 75020, United States

RECRUITING

Investigative Site US011

Houston, Texas, 77030, United States

NOT YET RECRUITING

Investigative Site US018

Houston, Texas, 77030, United States

NOT YET RECRUITING

Investigative Site US063

San Antonio, Texas, 78240, United States

RECRUITING

Investigative Site US053

Salt Lake City, Utah, 84112, United States

NOT YET RECRUITING

Investigative Site US076

Charlottesville, Virginia, 22903, United States

NOT YET RECRUITING

Investigative Site US057

Fairfax, Virginia, 22031, United States

NOT YET RECRUITING

Investigative Site US065

Fairfax, Virginia, 22031, United States

NOT YET RECRUITING

Investigative Site US064

Salem, Virginia, 24153, United States

RECRUITING

Investigative Site US032

Seattle, Washington, 98122, United States

NOT YET RECRUITING

Investigative Site US044

Madison, Wisconsin, 53706, United States

NOT YET RECRUITING

Investigative Site AU007

Liverpool, New South Wales, 02170, Australia

NOT YET RECRUITING

Investigative Site AU003

Wollongong, New South Wales, 02500, Australia

NOT YET RECRUITING

Investigative Site AU006

Woodville South, South Australia, 05011, Australia

NOT YET RECRUITING

Investigative Site AU005

Box Hill, Victoria, 03128, Australia

NOT YET RECRUITING

Investigative Site AU004

Melbourne, Victoria, 03000, Australia

NOT YET RECRUITING

Investigative Site AU001

Melbourne, Victoria, 03004, Australia

NOT YET RECRUITING

Investigative Site AU002

Canberra, 02605, Australia

NOT YET RECRUITING

Investigative Site AU008

Perth, 06009, Australia

NOT YET RECRUITING

Investigative Site AT002

Innsbruck, 06020, Austria

NOT YET RECRUITING

Investigative Site AT004

Linz, 04010, Austria

NOT YET RECRUITING

Investigative Site AT003

Salzburg, 05020, Austria

NOT YET RECRUITING

Investigative Site AT001

Vienna, 01090, Austria

NOT YET RECRUITING

Investigative Site BE008

Anderlecht, 01070, Belgium

NOT YET RECRUITING

Investigative Site BE003

Brussels, 01090, Belgium

NOT YET RECRUITING

Investigative Site BE009

Brussels, 01200, Belgium

NOT YET RECRUITING

Investigative Site BE001

Edegem, 02650, Belgium

NOT YET RECRUITING

Investigative Site BE005

Ghent, 09000, Belgium

NOT YET RECRUITING

Investigative Site BE007

Gilly, 06060, Belgium

NOT YET RECRUITING

Investigative Site BE004

Leuven, 03000, Belgium

NOT YET RECRUITING

Investigative Site BE006

Liège, 04000, Belgium

NOT YET RECRUITING

Investigative Site BE002

Yvoir, 05530, Belgium

NOT YET RECRUITING

Investigative Site CA001

Toronto, Ontario, M5G 2M9, Canada

NOT YET RECRUITING

Investigative Site CA005

Laval, Quebec, H7M 3L9, Canada

NOT YET RECRUITING

Investigative Site CA006

Montreal, Quebec, H4A 0B1, Canada

NOT YET RECRUITING

Investigative Site CA004

Québec, Quebec, G1J 1Z4, Canada

NOT YET RECRUITING

Investigative Site DK006

Aalborg, 09000, Denmark

NOT YET RECRUITING

Investigative Site DK005

Århus N, 08200, Denmark

NOT YET RECRUITING

Investigative Site DK001

Herlev, 02730, Denmark

NOT YET RECRUITING

Investigative Site DK004

Odense C, 05000, Denmark

NOT YET RECRUITING

Investigative Site DK003

Roskilde, 04000, Denmark

NOT YET RECRUITING

Investigative Site DK002

Vejle, 07100, Denmark

NOT YET RECRUITING

Investigative Site FI001

Helsinki, 00029, Finland

NOT YET RECRUITING

Investigative Site FI003

Tampere, 33521, Finland

NOT YET RECRUITING

Investigative Site FI002

Turku, 20521, Finland

NOT YET RECRUITING

Investigative Site FR013

Brest, 29200, France

NOT YET RECRUITING

Investigative Site FR012

Chambray-lès-Tours, 37170, France

NOT YET RECRUITING

Investigative Site FR014

Dijon, 21000, France

NOT YET RECRUITING

Investigative Site FR002

Lille, 59037, France

NOT YET RECRUITING

Investigative Site FR011

Lyon, 69008, France

NOT YET RECRUITING

Investigative Site FR016

Lyon, 69373, France

NOT YET RECRUITING

Investigative Site FR006

Marseille, 13385, France

NOT YET RECRUITING

Investigative Site FR015

Montpellier, 34298, France

NOT YET RECRUITING

Investigative Site FR003

Paris, 75013, France

NOT YET RECRUITING

Investigative Site FR009

Paris, 75015, France

NOT YET RECRUITING

Investigative Site FR004

Pessac, 33604, France

NOT YET RECRUITING

Investigative Site FR008

Poitiers, 86021, France

NOT YET RECRUITING

Investigative Site FR010

Reims, 51100, France

NOT YET RECRUITING

Investigative Site FR005

Rennes, 35042, France

NOT YET RECRUITING

Investigative Site FR007

Toulouse, 31059, France

NOT YET RECRUITING

Investigative Site FR001

Villejuif, 94805, France

NOT YET RECRUITING

Investigative Site DE018

Berlin, 10365, Germany

NOT YET RECRUITING

Investigative Site DE020

Berlin, 13353, Germany

NOT YET RECRUITING

Investigative Site DE003

Bochum, 44791, Germany

NOT YET RECRUITING

Investigative Site DE019

Bonn, 53127, Germany

NOT YET RECRUITING

Investigative Site DE008

Cologne, 50937, Germany

NOT YET RECRUITING

Investigative Site DE001

Dresden, 01307, Germany

NOT YET RECRUITING

Investigative Site DE013

Düsseldorf, 40225, Germany

NOT YET RECRUITING

Investigative Site DE004

Essen, 45147, Germany

NOT YET RECRUITING

Investigative Site DE005

Frankfurt, 60488, Germany

NOT YET RECRUITING

Investigative Site DE016

Freiburg im Breisgau, 79106, Germany

NOT YET RECRUITING

Investigative Site DE017

Göttingen, 37075, Germany

NOT YET RECRUITING

Investigative Site DE002

Halle, 06120, Germany

NOT YET RECRUITING

Investigative Site DE007

Hamburg, 20246, Germany

NOT YET RECRUITING

Investigative Site DE006

Hamburg, 22763, Germany

NOT YET RECRUITING

Investigative Site DE009

Leipzig, 04103, Germany

NOT YET RECRUITING

Investigative Site DE015

Munich, 81377, Germany

NOT YET RECRUITING

Investigative Site DE014

München, 81737, Germany

NOT YET RECRUITING

Investigative Site DE010

Nuremberg, 90419, Germany

NOT YET RECRUITING

Investigative Site DE011

Ulm, 89081, Germany

NOT YET RECRUITING

Investigative Site IT002

Bologna, 40138, Italy

NOT YET RECRUITING

Investigative Site IT010

Brescia, 25124, Italy

NOT YET RECRUITING

Investigative Site IT009

Candiolo, 10060, Italy

NOT YET RECRUITING

Investigative Site IT012

Foggia, 71122, Italy

NOT YET RECRUITING

Investigative Site IT006

Milan, 20132, Italy

NOT YET RECRUITING

Investigative Site IT008

Milan, 20133, Italy

NOT YET RECRUITING

Investigative Site IT011

Naples, 80131, Italy

NOT YET RECRUITING

Investigative Site IT003

Pisa, 56126, Italy

NOT YET RECRUITING

Investigative Site IT004

Roma, 00152, Italy

NOT YET RECRUITING

Investigative Site IT005

Rome, 00138, Italy

NOT YET RECRUITING

Investigative Site IT001

Rozzano, 20089, Italy

NOT YET RECRUITING

Investigative Site IT007

Verona, 37134, Italy

NOT YET RECRUITING

Investigative Site JP002

Kashiwa-shi, 277-8577, Japan

NOT YET RECRUITING

Investigative Site JP003

Kōtoku, 135-8550, Japan

NOT YET RECRUITING

Investigative Site JP007

Mitaka-shi, 181-8611, Japan

NOT YET RECRUITING

Investigative Site JP004

Osaka, 541-8567, Japan

NOT YET RECRUITING

Investigative Site JP006

Toyama, 930-0194, Japan

NOT YET RECRUITING

Investigative Site JP001

Yokohama, 241-8515, Japan

NOT YET RECRUITING

Investigative Site NL001

Amsterdam, 1081 HV, Netherlands

NOT YET RECRUITING

Investigative Site NL007

Eindhoven, 5623 EJ, Netherlands

NOT YET RECRUITING

Investigative Site NL005

Groningen, 9700 RB, Netherlands

NOT YET RECRUITING

Investigative Site NL003

Maastricht, 6202 AZ, Netherlands

NOT YET RECRUITING

Investigative Site NL006

Nieuwegein, 3430 EM, Netherlands

NOT YET RECRUITING

Investigative Site NO002

Bergen, 05021, Norway

NOT YET RECRUITING

Investigative Site NO001

Oslo, 00379, Norway

NOT YET RECRUITING

Investigative Site NO005

Stavanger, 04011, Norway

NOT YET RECRUITING

Investigative Site NO003

Trondheim, 07030, Norway

NOT YET RECRUITING

Investigative Site PL008

Gdansk, 80-214, Poland

NOT YET RECRUITING

Investigative Site PL003

Krakow, 31-501, Poland

NOT YET RECRUITING

Investigative Site PL007

Warsaw, 01-748, Poland

NOT YET RECRUITING

Investigative Site PL002

Warsaw, 02-507, Poland

NOT YET RECRUITING

Investigative Site PL001

Warsaw, 02-781, Poland

NOT YET RECRUITING

Investigative Site PL004

Wroclaw, 53-439, Poland

NOT YET RECRUITING

Investigative Site PR001

Dorado, 00646, Puerto Rico

RECRUITING

Investigative Site KR004

Goyang-si, 10408, South Korea

NOT YET RECRUITING

Investigative Site KR005

Seongnam, 13620, South Korea

NOT YET RECRUITING

Investigative Site KR007

Seongnam-si, 13496, South Korea

NOT YET RECRUITING

Investigative Site KR002

Seoul, 03080, South Korea

NOT YET RECRUITING

Investigative Site KR006

Seoul, 03722, South Korea

NOT YET RECRUITING

Investigative Site KR001

Seoul, 05505, South Korea

NOT YET RECRUITING

Investigative Site KR003

Seoul, 06351, South Korea

NOT YET RECRUITING

Investigative Site KR008

Seoul, 07417, South Korea

NOT YET RECRUITING

Investigative Site ES011

Badalona, 08916, Spain

NOT YET RECRUITING

Investigative Site ES003

Barcelona, 08035, Spain

NOT YET RECRUITING

Investigative Site ES002

Barcelona, 08036, Spain

NOT YET RECRUITING

Investigative Site ES014

Las Palmas de Gran Canaria, 35016, Spain

NOT YET RECRUITING

Investigative Site ES016

Madrid, 28007, Spain

NOT YET RECRUITING

Investigative Site ES006

Madrid, 28034, Spain

NOT YET RECRUITING

Investigative Site ES007

Madrid, 28040, Spain

NOT YET RECRUITING

Investigative Site ES012

Madrid, 28040, Spain

NOT YET RECRUITING

Investigative Site ES008

Madrid, 28041, Spain

NOT YET RECRUITING

Investigative Site ES013

Madrid, 28050, Spain

NOT YET RECRUITING

Investigative Site ES005

Palma de Mallorca, 07120, Spain

NOT YET RECRUITING

Investigative Site ES009

Santander, 39012, Spain

NOT YET RECRUITING

Investigative Site ES010

Seville, 41009, Spain

NOT YET RECRUITING

Investigative Site ES015

Valencia, 46009, Spain

NOT YET RECRUITING

Investigative Site ES017

Valencia, 46010, Spain

NOT YET RECRUITING

Investigative Site ES001

Valencia, 46014, Spain

NOT YET RECRUITING

Investigative Site ES004

Zaragoza, 50009, Spain

NOT YET RECRUITING

Investigative Site SE003

Linköping, 58185, Sweden

NOT YET RECRUITING

Investigative Site SE001

Malmo, 21428, Sweden

NOT YET RECRUITING

Investigative Site SE002

Solna, 171 76, Sweden

NOT YET RECRUITING

Investigative Site CH005

Basel, 04058, Switzerland

NOT YET RECRUITING

Investigative Site CH003

Bern, 03010, Switzerland

NOT YET RECRUITING

Investigative Site CH004

Geneva, 01205, Switzerland

NOT YET RECRUITING

Investigative Site CH002

Lausanne, 01011, Switzerland

NOT YET RECRUITING

Investigative Site CH001

Zurich, 08091, Switzerland

NOT YET RECRUITING

Investigative Site GB008

Dundee, DD1 9SY, United Kingdom

NOT YET RECRUITING

Investigative Site GB011

Guildford, GU2 7XX, United Kingdom

NOT YET RECRUITING

Investigative Site GB002

Headington, OX3 7LE, United Kingdom

NOT YET RECRUITING

Investigative Site GB001

Leeds, LS9 7TF, United Kingdom

NOT YET RECRUITING

Investigative Site GB009

London, EC1A 7BE, United Kingdom

NOT YET RECRUITING

Investigative Site GB004

London, NW3 2QG, United Kingdom

NOT YET RECRUITING

Investigative Site GB003

Manchester, M20 4BX, United Kingdom

NOT YET RECRUITING

Investigative Site GB006

Metropolitan Borough of Wirral, CH63 4JY, United Kingdom

NOT YET RECRUITING

Investigative Site GB010

Northwood, HA6 2RN, United Kingdom

NOT YET RECRUITING

Investigative Site GB005

Norwich, NR4 7UY, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Incyte Medical Monitor

  Incyte Corporation

  STUDY DIRECTOR

Central Study Contacts

Incyte Corporation Call Center (US)

CONTACT

1.855.463.3463; medinfo@incyte.com

Incyte Corporation Call Center (ex-US)

CONTACT

+800 00027423; eumedinfo@incyte.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2026
• First Posted: April 13, 2026
• Study Start: April 9, 2026
• Primary Completion (Estimated): September 15, 2028
• Study Completion (Estimated): March 19, 2029
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• 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.

Locations

SE (3); NL (5); FR (16); ES (17); US (66); CH (5); AU (4); DE (19); NO (4); KR (8); FI (3); CA (4); DK (6); PL (6); JP (6); BE (9); IT (12); PR (1); GB (10)