Recruiting

Phase 3

Chemotherapy with INCB161734A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma

Sponsor:

Incyte Corporation

Code:

NCT07522073

Conditions

Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

INCB161734

Placebo

Investigator's choice of chemotherapy

Study Details

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

Study ID

NCT07522073

Start date

Apr 9, 2026

Status verified date

Sep, 2026

Completion date

Mar 19, 2029

Anticipated

Primary completion date

Sep 15, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

588 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

INCB161734

Oral; tablet

Placebo

Oral; tablet

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:

Primary outcome measure

Overall Survival (OS) [ Time Frame: Up to approximately 3 years ]
Progression-free survival (PFS) by BICR [ Time Frame: Up to approximately 2 years ]
Objective Response by BICR [ Time Frame: Up to approximately 2 years ]

Central Contacts and Locations

Central contacts

Incyte Corporation Call Center (US)

1.855.463.3463 medinfo@incyte.com

Incyte Corporation Call Center (ex-US)

+800 00027423 eumedinfo@incyte.com

Locations

Investigative Site US016

Recruiting

Anchorage, Alaska, United States, 99508

Investigative Site US026

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Chandler, Arizona, United States, 85224

Investigative Site US027

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Los Angeles, California, United States, 90027

Investigative Site US036

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Los Angeles, California, United States, 90089

Investigative Site US048

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Los Angeles, California, United States, 91204-3640

Investigative Site US001

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Santa Monica, California, United States, 90404

Investigative Site US071

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Denver, Colorado, United States, 80218

Investigative Site US072

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Fort Myers, Florida, United States, 33901

Investigative Site US075

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Miami, Florida, United States, 33136

Investigative Site US074

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St. Petersburg, Florida, United States, 33701-4553

Investigative Site US073

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West Palm Beach, Florida, United States, 33401

Investigative Site US005

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Naperville, Illinois, United States, 60540

Investigative Site US009

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Springfield, Illinois, United States, 62702

Investigative Site US022

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Boston, Massachusetts, United States, 02215

Investigative Site US010

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Detroit, Michigan, United States, 48201

Investigative Site US078

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Grand Rapids, Michigan, United States, 49503

Investigative Site US066

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Maple Grove, Minnesota, United States, 55369

Investigative Site US077

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Hackensack, New Jersey, United States, 07601

Investigative Site US017

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Morristown, New Jersey, United States, 07960

Investigative Site US059

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Lake Success, New York, United States, 11042

Investigative Site US031

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New York, New York, United States, 10016

Investigative Site US003

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New York, New York, United States, 10065

Investigative Site US041

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New York, New York, United States, 10128

Investigative Site US029

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The Bronx, New York, United States, 10461

Investigative Site US035

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Chapel Hill, North Carolina, United States, 27514

Investigative Site US050

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Cleveland, Ohio, United States, 44106

Investigative Site US020

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Cleveland, Ohio, United States, 44195

Investigative Site US008

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Philadelphia, Pennsylvania, United States, 19104

Investigative Site US043

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Philadelphia, Pennsylvania, United States, 19107

Investigative Site US055

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Sioux Falls, South Dakota, United States, 57105-2140

Investigative Site US060

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Nashville, Tennessee, United States, 37203

Investigative Site US067

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Dallas, Texas, United States, 75246

Investigative Site US062

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Denison, Texas, United States, 75020

Investigative Site US011

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Houston, Texas, United States, 77030

Investigative Site US063

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San Antonio, Texas, United States, 78240

Investigative Site US053

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Salt Lake City, Utah, United States, 84112

Investigative Site US065

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Fairfax, Virginia, United States, 22031

Investigative Site US064

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Salem, Virginia, United States, 24153

Investigative Site US081

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Olympia, Washington, United States, 98506

Investigative Site US044

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Madison, Wisconsin, United States, 53792

Investigative Site CA001

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Toronto, Ontario, Canada, M5G 2M9

More Information

Sponsor

Incyte Corporation

Last update posted

Sep 22, 2026

Last verified

Sep, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-04. This information was provided to ClinicalTrials.gov by Incyte Corporation on 2026-09-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.