Clinical Trials /

A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies

NCT03652077

Description:

The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of INCAGN02390 in participants with select advanced malignancies.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies
  • Official Title: A Phase 1, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCAGN02390 in Participants With Select Advanced Malignancies

Clinical Trial IDs

  • ORG STUDY ID: INCAGN 2390-101
  • NCT ID: NCT03652077

Conditions

  • Cervical Cancer
  • Gastric Cancer
  • Stomach Cancer
  • Gastroesophageal Junction Cancer
  • Esophageal Cancer
  • Hepatocellular Carcinoma
  • Melanoma
  • Uveal Melanoma
  • Merkel Cell Carcinoma
  • Mesothelioma
  • MSI
  • Non-small Cell Lung Cancer
  • NSCLC
  • Ovarian Cancer
  • Squamous Cell Carcinoma of the Head and Neck
  • Small Cell Lung Cancer
  • Renal Cell Carcinoma
  • RCC
  • Triple-negative Breast Cancer
  • Urothelial Carcinoma
  • Mismatch Repair Deficiency

Interventions

DrugSynonymsArms
INCAGN02390INCAGN02390

Purpose

The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of INCAGN02390 in participants with select advanced malignancies.

Trial Arms

NameTypeDescriptionInterventions
INCAGN02390Experimental
  • INCAGN02390

Eligibility Criteria

        Inclusion Criteria:

          -  Participants with locally advanced or metastatic tumors who are not eligible for any
             available therapy likely to convey clinical benefit (locally advanced disease must not
             be amenable to resection with curative intent).

          -  Participants who have disease progression after treatment with available therapies
             that are known to confer clinical benefit or who are intolerant to treatment.

          -  Willingness and ability to safely undergo pretreatment and on-treatment tumor biopsies
             (core or excisional).

          -  Eastern Cooperative Oncology Group performance status 0 or 1.

          -  Willingness to avoid pregnancy or fathering children based on protocol-defined
             criteria.

        Exclusion Criteria:

          -  Laboratory values at screening outside the protocol-defined ranges.

          -  Administration of colony-stimulating factors within 14 days before Study Day 1.

          -  Receipt of anticancer medications or investigational drugs within protocol-defined
             intervals before the first administration of study drug.

          -  Receipt of a live vaccine within 30 days of planned start of study drug.

        Note: Examples of live vaccines include, but are not limited to, the following: measles,
        mumps, rubella, chicken pox/zoster, yellow fever, rabies, Bacillus Calmette-Guérin, and
        typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus
        vaccines and are allowed; however, intranasal influenza vaccines are live-attenuated
        vaccines and are not allowed.

          -  Active autoimmune disease that required systemic treatment in the past (ie, with use
             of disease-modifying agents, corticosteroids, or immunosuppressive drugs).

          -  Known active central nervous system metastases and/or carcinomatous meningitis.

          -  Known additional malignancy that is progressing or requires active treatment, or
             history of other malignancy within 2 years of study entry with the exception of cured
             basal cell or squamous cell carcinoma of the skin, superficial bladder cancer,
             prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other
             noninvasive or indolent malignancy, or cancers from which the participant has been
             disease-free for > 1 year, after treatment with curative intent.

          -  Evidence of active, noninfectious pneumonitis or history of interstitial lung disease.

          -  Active infection requiring systemic therapy.

          -  Evidence of active HBV or HCV infection.

          -  Known history of HIV (HIV 1/2 antibodies).

          -  Known allergy or reaction to any component of study drug or formulation components.

          -  Prior treatment with an anti-TIM-3 antibody for any indication.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of treatment-emergent adverse events
Time Frame:Up to 12 months
Safety Issue:
Description:Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.

Secondary Outcome Measures

Measure:Cmax of INCAGN02390
Time Frame:Up to 12 months
Safety Issue:
Description:Maximum observed plasma or serum concentration.
Measure:Tmax of INCAGN02390
Time Frame:Up to 12 months
Safety Issue:
Description:Time to maximum concentration.
Measure:Cmin of INCAGN02390
Time Frame:Up to 12 months
Safety Issue:
Description:Minimum observed plasma or serum concentration over the dose interval.
Measure:AUC0-t of INCAGN02390
Time Frame:Up to 12 months
Safety Issue:
Description:Area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t.
Measure:Objective response rate
Time Frame:Up to 12 months
Safety Issue:
Description:Defined as the percentage of participants having complete response (CR) or partial response (PR) determined by investigator assessment of radiographic disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Measure:Duration of response
Time Frame:Up to 12 months
Safety Issue:
Description:Defined as time from earliest date of disease response (CR or PR) until earliest date of disease progression (determined by investigator assessment of radiographic disease per RECIST v1.1) or death from any cause, if occurring sooner than progression.
Measure:Disease control rate
Time Frame:Up to 12 months
Safety Issue:
Description:Defined as percentage of participants having CR, PR, or stable disease as best on-study response.
Measure:Progression-free survival
Time Frame:Up to 12 months
Safety Issue:
Description:Defined as the time from date of first dose of study drug until the earliest date of disease progression (determined by investigator assessment of objective radiographic disease per RECIST v1.1) or death from any cause if occurring sooner than progression.
Measure:Level of binding of INCAGN02390 to TIM-3
Time Frame:Up to approximately 3 months
Safety Issue:
Description:Assessed from participant whole blood samples.
Measure:Immunogenicity of INCAGN02390
Time Frame:Up to 12 months
Safety Issue:
Description:Defined as the occurrence of specific ADA to INCAGN02390.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Incyte Corporation

Trial Keywords

  • Advanced malignancies
  • immunoglobulin (Ig)G1k monoclonal antibody
  • T-cell immunoglobulin and mucin domain 3 (TIM-3)

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