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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Incyte Corporation
Study ID
NCT03059823
Phase
PHASE1
Status
Completed

Conditions

  • Locally Advanced Solid Tumors
  • Metastatic Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Nov 15, 2016
Status verified
Aug 2025
Primary completion
May 22, 2024
Completion
May 22, 2024

Study Design

Enrollment
325 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation-Q2W
    INCMGA00012 treatment once every 2 weeks.
  • Experimental: Dose Escalation- Q3W
    INCMGA00012 treatment once every 3 weeks.
  • Experimental: Dose Escalation- Q4W
    INCMGA00012 treatment once every 4 weeks.
  • Experimental: Expansion Cohort
    INCMGA00012 treatment for locally advanced or metastatic solid tumors.

Primary Outcome Measure

Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v4.03 [ Time Frame: 24 months ]

Locations (8)

FacilityCityStateZIPSite coordinators
Honor Health Research InstituteScottsdaleArizona85258-
South Texas Accelerated Research TherapeuticsGrand RapidsMichigan49546-
Rutgers Cancer Institute of NjNew BrunswickNew Jersey08901-
Carolina Bio-Oncology Institute, PllcHuntersvilleNorth Carolina28078-
Houston Methodist HospitalHoustonTexas77030-
University of Texas Md Anderson Cancer CenterHoustonTexas77030-
South Texas Accelerated Research TherapeuticsSan AntonioTexas78229-
Virginia Commonwealth University Massey Cancer CenterRichmondVirginia23298-

Find similar trials in Scottsdale, AZ

By research site
Honor Health Research Institute· Scottsdale, AZSouth Texas Accelerated Research Therapeutics· Grand Rapids, MIRutgers Cancer Institute of Nj· New Brunswick, NJCarolina Bio-Oncology Institute, Pllc· Huntersville, NCHouston Methodist Hospital· Houston, TXUniversity of Texas Md Anderson Cancer Center· Houston, TX

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