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

RECRUITINGPhase 3Sponsored by Incyte Corporation
Actively Recruiting
PhasePhase 3
SponsorIncyte Corporation
Started2026-04-09
Est. completion2028-09-15
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations65 sites

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).

Eligibility

Age: 18 Years+Healthy volunteers 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.

Conditions2

CancerSolid Tumors

Interventions2

Locations65 sites

Investigative Site US058
Birmingham, Alabama, 35233
Investigative Site US016
Anchorage, Alaska, 99508
Investigative Site US026
Chandler, Arizona, 85224
Investigative Site US045
Tucson, Arizona, 85719
Investigative Site US051
Duarte, California, 91010

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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