Trial 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).
Status: OPEN - Recruiting
Trial identifier: NCT07522073
Sponsor: Incyte Corporation
Phase: III
Diagnosis: Metastatic (Stage IV) pancreatic ductal adenocarcinoma.
Line of therapy: First line
Treatment: Randomised 1:1 to: Arm A: INCB161734 (oral KRASG12D inhibitor) + Gem/Abrax or mFFX chemotherapy (IV); Arm B: Placebo + Gem/Abrax or mFFX chemotherapy (IV)
  • Key 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
  • Key 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

DAWN-303

Locations: Epworth Richmond, Epworth Freemasons (East Melbourne), Epworth Eastern (Box Hill)

Epworth PI: A/Prof Sumitra Ananda

Jreissati Pancreatic Centre at Epworth 

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Please contact us for more information on 03 9426 8880 or email [email protected]


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