Advanced/Metastatic

A Study to Evaluate INCB186748 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation

Incyte Study ID:
INCB186748-101
CT.gov ID:
NCT06818812
Eudra ID:
N/A
EU CT Number:
2024-519018-30-00
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463 or [email protected]
Recruiting
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Clinical Study Purpose

The purpose of this study is to evaluate INCB186748 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation.

Clinical Study Summary

MEDICAL CONDITION(S)
  • Advanced/Metastatic
    • PRODUCT
  • Drug: INCB186748
  • Drug: Cetuximab
  • Drug: GEMNabP
  • Drug: mFOLFIRINOX
    • COLLABORATORS
    N/A
    DATE
    Mar 2025 - Mar 2027
    TYPE
    Interventional
    PHASE
    Phase 1
    SEX
    Female & Male
    AGE
    18 Years - NA
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Name
    Status
    Contact Us
    Name
    FLORIDA CANCER SPECIALISTS
    SARASOTA, FL, US, 34232
    Status
    Recruiting
    Name
    HACKENSACK UNIVERSITY MEDICAL CENTER
    HACKENSACK, NJ, US, 07601
    Status
    Recruiting
    Name
    SARAH CANNON RESEARCH INSTITUE AT HEALTHONE
    DENVER, CO, US, 80218
    Status
    Recruiting
    Name
    SIDNEY KIMMEL COMPREHENSIVE CANCER CENTER AT JOHNS HOPKINS
    BALTIMORE, MD, US, 21287-7049
    Status
    Recruiting
    Name
    SCRI ONCOLOGY PARTNERS
    NASHVILLE, TN, US, 37203
    Status
    Recruiting
    Name
    JEFFERSON UNIVERSITY HOSPITALS
    PHILADELPHIA, PA, US, 19107
    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 inhibitor.
    • Known additional invasive malignancy within 1 year of the first dose of study drug.

    Protocol Summary

    Incyte Study ID:
    INCB186748-101
    Primary Purpose:
    Treatment
    Allocation:
    Non-randomized
    Study Design:
    Sequential Assignment
    Masking:
    None (Open Label)
    Interventions:
  • Drug: INCB186748
  • Drug: Cetuximab
  • Drug: GEMNabP
  • Drug: mFOLFIRINOX
    • Enrollment:
    308
    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 approximately 12 months and 60 days

    Number of participants with TEAEs leading to dose modification or discontinuation

    Timeframe: Up to approximately 12 months and 60 days

    Secondary Outcome
    Open

    INCB186748 pharmacokinetic (PK) in Plasma

    Timeframe: Up to approximately 12 months

    Objective Response Rate (ORR)

    Timeframe: Up to approximately 12 months

    Disease Control Response (DCR)

    Timeframe: Up to approximately 12 months

    Duration of Response (DOR)

    Timeframe: Up to approximately 12 months