Advanced/Metastatic

A Phase 1 Study of INCMGA00012 in Patients With Advanced Solid Tumors

Incyte Study ID:
INCMGA 0012-101
CT.gov ID:
NCT03059823
View Results Summary
Eudra ID:
2017-000865-63
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463 or [email protected]
Study Complete
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Clinical Study Purpose

The primary goal of this Phase 1 study is to characterize the safety and tolerability of INCMGA00012 and establish the maximum tolerated dose (MTD) of INCMGA00012 administered on either every two week or every four week schedules of administration among patients with solid tumors. Pharmacokinetics, pharmacodynamics, and the anti-tumor activity of INCMGA00012 will also be assessed.

The purpose of Amendment 5 is to obtain additional safety experience at the newly defined recommended Phase 2 dose of 500 mg every 4 weeks in patients with endometrial cancer, specifically either microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). Additionally, every 3 week (Q3W) flat-dosing will be studied in an additional tumor agnostic cohort.

Clinical Study Summary

MEDICAL CONDITION(S)
  • Advanced/Metastatic
    • PRODUCT
  • Drug: retifanlimab
    • COLLABORATORS
    N/A
    DATE
    Nov 2016 - May 2024
    TYPE
    Interventional
    PHASE
    Phase 1
    SEX
    Female & Male
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Name
    Contact Us
    Name
    HONOR HEALTH RESEARCH INSTITUTE
    SCOTTSDALE, AZ, US, 85258
    Name
    CAROLINA BIO-ONCOLOGY INSTITUTE, PLLC
    HUNTERSVILLE, NC, US, 28078
    Name
    UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER
    HOUSTON, TX, US, 77030
    Name
    Houston Methodist Hospital
    Houston, Texas, US, 77030
    Name
    SOUTH TEXAS ACCELERATED RESEARCH THERAPEUTICS
    SAN ANTONIO, TX, US, 78229
    Name
    VIRGINIA COMMONWEALTH UNIVERSITY MASSEY CANCER CENTER
    RICHMOND, VA, US, 23298

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Histologically proven, locally advanced unresectable or metastatic solid tumors for whom no approved therapy with demonstrated clinical benefit is available or standard treatment was declined. Patients enrolled to Cohort H (endometrial cancer 500 mg Q4W) must have MSI-H or dMMR endometrial cancer, as determined by a local laboratory using IHC or PCR methods and must also have tissue (fresh or archival) available for central confirmation of diagnosis
    • Expansion cohort(s): Progression during or following at least 1, and up to 5, previous systemic therapies, consistent with the standard of care for the specific tumor type.

    Exclusion Criteria

    • Symptomatic central nervous system (CNS) metastases.
    • For Cohort Expansion, patients who have previously received an immune checkpoint inhibitor (e.g., anti-PD-L1, anti-PD-1, anti-CTLA-4) are not eligible for this study.

    Protocol Summary

    Incyte Study ID:
    INCMGA 0012-101
    Primary Purpose:
    Treatment
    Allocation:
    Non-randomized
    Study Design:
    Parallel Assignment
    Masking:
    None (Open Label)
    Interventions:
    Drug
    Enrollment:
    325
    Primary Outcome
    Open

    Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v4.03

    Timeframe: 24 months

    MTD

    Timeframe: 24 months

    Secondary Outcome
    Open

    AUC

    Timeframe: 24 months

    Cmax

    Timeframe: 24 months

    Tmax

    Timeframe: 24 months

    Ctrough

    Timeframe: 24 months

    Total body clearance of the drug from plasma (CL) of INCMGA00012

    Timeframe: 24 months

    Vss

    Timeframe: 24 months

    t1/2

    Timeframe: 24 months

    ADA

    Timeframe: 24 months