Advanced/Metastatic

A study to evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation

Incyte Study ID:
INCB161734-101
CT.gov ID:
NCT06179160
Eudra ID:
N/A
EU CT Number:
2023-507091-47-00
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463 or [email protected]
Recruiting
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Clinical Study Purpose

This study is conducted to determine the safety and tolerability of INCB161734 as a single agent or in combination with other anticancer therapies.

Clinical Study Summary

MEDICAL CONDITION(S)
  • Advanced/Metastatic
    • PRODUCT
  • Drug: INCB161734
  • Drug: Cetuximab
  • Drug: Retifanlimab
  • Drug: GEMNabP
  • Drug: mFOLFIRINOX
    • COLLABORATORS
    N/A
    DATE
    Jan 2024 - Jan 2027
    TYPE
    Interventional
    PHASE
    Phase 1
    SEX
    Female & Male
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Name
    Status
    Contact Us
    Name
    PETER MACCALLUM CANCER CENTRE
    NORTH MELBOURNE, VIC, Australia, 3051
    Status
    Recruiting
    Name
    THE ALFRED HOSPITAL
    MELBOURNE, VIC, Australia, 03004
    Status
    Recruiting
    Name
    CHRIS OBRIEN LIFEHOUSE
    CAMPERDOWN, NSW, Australia, 02050
    Status
    Recruiting
    Name
    ST VINCENT'S HOSPITAL SYDNEY
    DARLINGHURST, NSW, Australia, 02010
    Status
    Recruiting
    Name
    LINEAR CLINICAL RESEARCH
    NEDLANDS, WA, Australia, 06009
    Status
    Recruiting
    Name
    WEILL CORNELL MEDICINE
    NEW YORK, NY, US, 10021
    Status
    Recruiting
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    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • ≥18 years old
    • Locally-advanced or metastatic solid tumor with KRAS G12D mutation

    Exclusion Criteria

    • Prior treatment with any KRAS G12D inhibitor
    • Known additional invasive malignancy within 1 year of the first dose of study drug

    Protocol Summary

    Incyte Study ID:
    INCB161734-101
    Primary Purpose:
    Treatment
    Allocation:
    Non-randomized
    Study Design:
    Sequential Assignment
    Masking:
    None (Open Label)
    Interventions:
  • Drug: INCB161734
  • Drug: Cetuximab
  • Drug: Retifanlimab
  • Drug: GEMNabP
  • Drug: mFOLFIRINOX
    • Enrollment:
    466
    Primary Outcome
    Open

    Number of participants with Dose Limiting Toxicities (DLTs)

    Timeframe: Up to 28 days

    Number of participants with Treatment-emergent Adverse Events (TEAEs)

    Timeframe: Up to 2 years and 90 days

    Number of participants with TEAEs leading to dose modification or discontinuation

    Timeframe: Up to 2 years and 90 days

    Secondary Outcome
    Open

    INCB161734 pharmacokinetic (PK) in Plasma

    Timeframe: Up to approximately 90 days

    Objective Response Rate (ORR)

    Timeframe: Up to 2 years

    Disease Control Response (DCR)

    Timeframe: Up to 2 years

    Duration of Response (DOR)

    Timeframe: Up to 2 years