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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Incyte Corporation
Study ID
NCT07522073
Phase
PHASE3
Status
Recruiting
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Conditions

  • Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • INCB161734 — DRUG
    Oral; tablet
  • Placebo — DRUG
    Oral; tablet
  • 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:

Study Details

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).

Key Dates

Start date
Apr 9, 2026
Status verified
Jun 2026
Primary completion
Sep 15, 2028
Completion
Mar 19, 2029

Study Design

Enrollment
588 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: Up to approximately 3 years ]

Central Contacts

Locations (68)

FacilityCityStateZIPSite coordinators
Investigative Site US058BirminghamAlabama35233-
Investigative Site US016AnchorageAlaska99508-
Investigative Site US026ChandlerArizona85224-
Investigative Site US045TucsonArizona85719-
Investigative Site US051DuarteCalifornia91010-
Investigative Site US048Fountain ValleyCalifornia92708-
Investigative Site US049IrvineCalifornia92612-
Investigative Site US054La JollaCalifornia92093-
Investigative Site US027Los AngelesCalifornia90027-
Investigative Site US036Los AngelesCalifornia90033-
Investigative Site US034San FranciscoCalifornia94143-
Investigative Site US001Santa MonicaCalifornia90404-
Investigative Site US071DenverColorado80218-
Investigative Site US013Washington D.C.District of Columbia20007-
Investigative Site US046Washington D.C.District of Columbia20016-
Investigative Site US072Fort MyersFlorida33901-
Investigative Site US075MiamiFlorida33136-
Investigative Site US074St. PetersburgFlorida33701-4553-
Investigative Site US073West Palm BeachFlorida33401-
Investigative Site US023AtlantaGeorgia30322-
Investigative Site US079ChicagoIllinois60637-
Investigative Site US030EvanstonIllinois60201-
Investigative Site US005NapervilleIllinois60540-
Investigative Site US009SpringfieldIllinois62702-
Investigative Site US021IndianapolisIndiana46250-
Investigative Site US007New OrleansLouisiana70121-
Investigative Site US022BostonMassachusetts02215-
Investigative Site US006Ann ArborMichigan48109-
Investigative Site US010DetroitMichigan48201-
Investigative Site US078Grand RapidsMichigan49546-
Investigative Site US012YpsilantiMichigan48197-
Investigative Site US066Maple GroveMinnesota55369-
Investigative Site US047HattiesburgMississippi39401-
Investigative Site US077HackensackNew Jersey07601-
Investigative Site US017MorristownNew Jersey07960-
Investigative Site US059Lake SuccessNew York11042-
Investigative Site US003New YorkNew York10065-
Investigative Site US004New YorkNew York10032-
Investigative Site US031New YorkNew York10016-
Investigative Site US041New YorkNew York10029-
Investigative Site US029The BronxNew York10461-
Investigative Site US035Chapel HillNorth Carolina27514-
Investigative Site US020ClevelandOhio44195-
Investigative Site US050ClevelandOhio44106-
Investigative Site US033ColumbusOhio43210-
Investigative Site US042PortlandOregon97239-
Investigative Site US008PhiladelphiaPennsylvania19104-
Investigative Site US043PhiladelphiaPennsylvania19107-
Investigative Site US056PittsburghPennsylvania15212-
Investigative Site US082CharlestonSouth Carolina29425-
Investigative Site US055Sioux FallsSouth Dakota57105-
Investigative Site US039NashvilleTennessee37203-
Investigative Site US060NashvilleTennessee37203-
Investigative Site US070NashvilleTennessee37232-
Investigative Site US067DallasTexas75246-
Investigative Site US062DenisonTexas75020-
Investigative Site US011HoustonTexas77030-
Investigative Site US018HoustonTexas77030-
Investigative Site US063San AntonioTexas78240-
Investigative Site US080San AntonioTexas78229-
Investigative Site US053Salt Lake CityUtah84112-
Investigative Site US076CharlottesvilleVirginia22903-
Investigative Site US057FairfaxVirginia22031-
Investigative Site US065FairfaxVirginia22031-
Investigative Site US064SalemVirginia24153-
Investigative Site US081OlympiaWashington98506-
Investigative Site US032SeattleWashington98122-
Investigative Site US044MadisonWisconsin53792-

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