Skin Cancer, Liver Cancer, Kidney Cancer, Colorectal Cancer

Interventional Study of INCB 99280 with Ipilimumab in Participants with Select Solid Tumors

Incyte Study ID:
INCB 99280-205
CT.gov ID:
NCT05909995
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463 or [email protected]
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Clinical Study Purpose

The purpose of this study is to characterize the safety, tolerability, PK, and efficacy of INCB 99280 in combination with ipilimumab in participants with select solid tumors.

Clinical Study Summary

MEDICAL CONDITION(S)
  • Skin Cancer
  • Liver Cancer
  • Kidney Cancer
  • Colorectal Cancer
    • PRODUCT
  • Drug: INCB 99280 with Ipilimumab
    • COLLABORATORS
    N/A
    DATE
    Aug 2023 - Sep 2024
    TYPE
    Interventional
    PHASE
    Phase 1
    SEX
    Female & Male
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Location
    Status
    Location
    PRINCESS MARGARET CANCER CENTER
    TORONTO, ON, Canada, M5G 2M9
    Status
    Recruiting
    Location
    HENRY FORD HEALTH SYSTEM
    DETROIT, MI, US, 48202
    Status
    Recruiting
    Location
    VALKYRIE CLINICAL TRIALS
    LOS ANGELES, CA, US, 90067
    Status
    Recruiting
    Location
    SHARP MEMORIAL HOSPITAL
    SAN DIEGO, CA, US, 92123
    Status
    Recruiting
    Location
    ALLIANCE FOR MULTISPECIALTY RESEARCH LLC
    KNOXVILLE, TN, US, 37920
    Status
    Recruiting
    Location
    UC IRVINE MEDICAL CENTER
    ORANGE, CA, US, 92868
    Status
    Recruiting

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Prior systemic therapy, diagnoses and disease setting as follows:
    • For Part 1 (dose escalation), and no history of treatment with anti-CTLA-4 or anti-PD-(L)1 therapy and one of the following,

    Exclusion Criteria

    • Known history of an additional malignancy.
    • Central nervous system (CNS) metastases requiring treatment and/or leptomeningeal disease.

    Protocol Summary

    Incyte Study ID:
    INCB 99280-205
    Primary Purpose:
    Treatment
    Allocation:
    Non-randomized
    Study Design:
    Sequential Assignment
    Masking:
    None (Open Label)
    Interventions:
    Drug
    Enrollment:
    8
    Primary Outcome
    Open

    Occurence of DLTs

    Timeframe: 2 Years

    Incidence of TEAEs

    Timeframe: 2 Years

    Incidence of TEAEs leading to dose interruption, dose reduction, or discontinuation of either of the study drugs

    Timeframe: 2 Years

    Secondary Outcome
    Open

    Concentration of INCB099280 in plasma

    Timeframe: 2 Years

    Objective response

    Timeframe: 2 Years

    Disease control

    Timeframe: 2 Years

    Duration of Response

    Timeframe: 2 Years