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

Purpose

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).

Condition

Solid Tumors

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

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

Phase: Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Double (Participant, Investigator)

Arm Groups

Arm	Description	Assigned Intervention
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: INCB161734 Oral; tablet 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
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: Placebo Oral; tablet 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

Recruiting Locations

Investigative Site US059
Lake Success, New York 11042

Investigative Site US060
Nashville, Tennessee 37203

Investigative Site US067
Dallas, Texas 75246

Investigative Site US062
Denison, Texas 75020

Investigative Site US063
San Antonio, Texas 78240

Investigative Site US064
Salem, Virginia 24153

Investigative Site PR001
Dorado, Puerto Rico 00646

More Details

NCT ID: NCT07522073
Status: Recruiting
Sponsor: Incyte Corporation

Study Contact

Incyte Corporation Call Center (US)
1.855.463.3463
medinfo@incyte.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.