Clinical Trials /

A Study of INCMGA00012, INCB001158, and the Combination in Japanese Participants With Advanced Solid Tumors

NCT03910530

Description:

The purpose of this study is to assess the safety and tolerability and the pharmacokinetics (PK) of INCMGA00012 (PD-1 Inhibitor), INCB001158 (Arginase Inhibitor), and the combination in Japanese participants with advanced solid tumor malignancies.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Active, not recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of INCMGA00012, INCB001158, and the Combination in Japanese Participants With Advanced Solid Tumors
  • Official Title: A Phase 1b Study of INCMGA00012 (PD-1 Inhibitor), INCB001158 (Arginase Inhibitor), and the Combination in Japanese Participants With Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: INCMGA 0012-104
  • NCT ID: NCT03910530

Conditions

  • Advanced Solid Tumors
  • Metastatic Solid Tumors

Interventions

DrugSynonymsArms
INCMGA00012INCMGA00012
INCB001158INCB001158 75 mg
INCMGA00012 + INCB001158INCMGA00012 + INCB001158

Purpose

The purpose of this study is to assess the safety and tolerability and the pharmacokinetics (PK) of INCMGA00012 (PD-1 Inhibitor), INCB001158 (Arginase Inhibitor), and the combination in Japanese participants with advanced solid tumor malignancies.

Trial Arms

NameTypeDescriptionInterventions
INCMGA00012ExperimentalSingle-agent INCMGA00012.
  • INCMGA00012
INCB001158 75 mgExperimentalSingle-agent INCB001158.
  • INCB001158
INCB001158 100 mgExperimentalSingle-agent INCB001158.
  • INCB001158
INCMGA00012 + INCB001158ExperimentalCombination of INCMGA00012 and INCB001158.
  • INCMGA00012 + INCB001158

Eligibility Criteria

        Inclusion Criteria:

          -  Participant is Japanese

          -  Histologically or cytologically confirmed diagnosis of any locally advanced or
             metastatic solid tumors not amenable to local or other curative therapy.

          -  Participants with nonevaluable lesions are allowed.

          -  Life expectancy > 3 months.

          -  Eastern Cooperative Oncology Group performance status 0 to 1.

          -  Female participants agree to use medically acceptable contraceptive measures, should
             not be breastfeeding, and must have a negative pregnancy test before the start of
             study drug administration.

          -  Female participants of childbearing potential must understand and accept that
             pregnancy must be avoided during participation in the study.

          -  Male participants should avoid unprotected sex with women of childbearing potential
             and refrain from donating sperm during participation the study.

        Exclusion Criteria:

          -  Receipt of anticancer therapy or participation in another interventional clinical
             study within 14 days before the first administration of study drug with the following
             exceptions: Immunotherapy or biological therapy (eg, monoclonal antibodies) within 21
             days the first administration of study drug; 6 weeks for mitomycin-C or nitrosoureas;
             7 days for tyrosine kinase inhibitors.

          -  Radiotherapy within 14 days of first dose of study treatment with the following
             exceptions: 28 days for pelvic radiotherapy; 6 months for thoracic region radiotherapy
             that is > 30 Gy.

          -  Toxicity of prior therapy and/or complications from surgical intervention that has not
             recovered to ≤ Grade 1 or baseline within 7 days before starting study drug treatment
             (with the exception of anemia not requiring transfusion support and any grade of
             alopecia). Note: Endocrinopathy, if well-managed, is not exclusionary and should be
             discussed with sponsor medical monitor.

          -  Receipt of prior systemic treatment with an arginase inhibitor

          -  Immune-related toxicity during prior checkpoint inhibitor therapy for which permanent
             discontinuation of therapy is recommended (per product label or consensus guidelines),
             OR any immune-related toxicity requiring intensive or prolonged immunosuppression to
             manage (with the exception of endocrinopathy that is well controlled on replacement
             hormones).

          -  Active autoimmune disease requiring systemic immunosuppression in excess of
             physiologic maintenance doses of corticosteroids (> 10 mg of prednisone or
             equivalent).

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

          -  Known active hepatitis A virus, hepatitis B virus, or hepatitis C virus infection.

          -  Known HIV infection.

          -  Active infections requiring systemic therapy.

          -  Known hypersensitivity to another monoclonal antibody that cannot be controlled with
             standard measures and/or known hypersensitivity ≥ Grade 3, or severe reaction, to
             study treatments or any of their excipients or additives.

          -  Participants with impaired cardiac function or clinically significant cardiac disease.

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

          -  Participant is pregnant or breastfeeding.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Part 1: Number of treatment-emergent adverse events in participants receiving single-agent INCMGA00012
Time Frame:Up to approximately 2 years
Safety Issue:
Description:Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.

Secondary Outcome Measures

Measure:Part 1: Cmax of single-agent INCMGA000012
Time Frame:Up to 15 days
Safety Issue:
Description:Maximum observed plasma or serum concentration.
Measure:Part 1: Cmax of single-agent INCB001158
Time Frame:Up to 15 days
Safety Issue:
Description:Maximum observed plasma or serum concentration.
Measure:Part 1: Tmax of single-agent INCMGA000012
Time Frame:Up to 15 days
Safety Issue:
Description:Time to maximum concentration.
Measure:Part 1: Tmax of single-agent INCB001158
Time Frame:Up to 15 days
Safety Issue:
Description:Time to maximum concentration.
Measure:Part 1: Cmin of single-agent INCMGA000012
Time Frame:Up to 15 days
Safety Issue:
Description:Minimum observed plasma or serum concentration over the dose interval.
Measure:Part 1: Cmin of single-agent INCB001158
Time Frame:Up to 15 days
Safety Issue:
Description:Minimum observed plasma or serum concentration over the dose interval.
Measure:Part 1: AUCt of single-agent INCMGA000012
Time Frame:Up to 15 days
Safety Issue:
Description:Area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t.
Measure:Part 1: AUCt of single-agent INCB001158
Time Frame:Up to 15 days
Safety Issue:
Description:Area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t.
Measure:Part 1: t½ of single-agent INCMGA000012
Time Frame:Up to 15 days
Safety Issue:
Description:Apparent terminal-phase disposition half-life.
Measure:Part 1: t½ of single-agent INCB001158
Time Frame:Up to 15 days
Safety Issue:
Description:Apparent terminal-phase disposition half-life.
Measure:Part 2: Cmax of INCMGA00012 and INCB001158 as a combination treatment
Time Frame:Up to 15 days
Safety Issue:
Description:Maximum observed plasma or serum concentration.
Measure:Part 2: Tmax of INCMGA00012 and INCB001158 as a combination treatment
Time Frame:Up to 15 days
Safety Issue:
Description:Time to maximum concentration.
Measure:Part 2: Cmin of INCMGA00012 and INCB001158 as a combination treatment
Time Frame:Up to 15 days
Safety Issue:
Description:Minimum observed plasma or serum concentration over the dose interval.
Measure:Part 2: AUCt of INCMGA00012 and INCB001158 as a combination treatment
Time Frame:Up to 15 days
Safety Issue:
Description:Area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t.
Measure:Part 2: t½ of INCMGA00012 and INCB001158 as a combination treatment
Time Frame:Up to 15 days
Safety Issue:
Description:Apparent terminal-phase disposition half-life.
Measure:Part 1 and Part 2: Overall response rate with single-agent INCMGA00012
Time Frame:Up to 2 years
Safety Issue:
Description:Defined as the percentage of participants experiencing a partial response (PR) or complete response (CR) as determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Measure:Part 1 and Part 2: Overall response rate with single-agent INCB001158
Time Frame:Up to 2 years
Safety Issue:
Description:Defined as the percentage of participants experiencing a PR or CR as determined by the investigator according to RECIST v1.1.
Measure:Part 1 and Part 2: Overall response rate with INCMGA00012 in combination with INCB001158
Time Frame:Up to 2 years
Safety Issue:
Description:Defined as the percentage of participants experiencing a PR or CR as determined by the investigator according to RECIST v1.1.
Measure:Part 1 and Part 2: Disease control rate with single-agent INCMGA00012
Time Frame:Up to 2 years
Safety Issue:
Description:Defined as the number of participants maintaining either an overall response rate or stable disease according to RECIST v1.1.
Measure:Part 1 and Part 2: Disease control rate with single-agent INCB001158
Time Frame:Up to 2 years
Safety Issue:
Description:Defined as the number of participants maintaining either an overall response rate or stable disease according to RECIST v1.1.
Measure:Part 1 and Part 2: Disease control rate with INCMGA00012 in combination with INCB001158
Time Frame:Up to 2 years
Safety Issue:
Description:Defined as the number of participants maintaining either an overall response rate or stable disease according to RECIST v1.1.
Measure:Part 1 and Part 2: Duration of response with single-agent INCMGA00012
Time Frame:Up to 2 years
Safety Issue:
Description:Defined as the time from first observed response until onset of disease progression according to RECIST v1.1 or death due to any cause.
Measure:Part 1 and Part 2: Duration of response with single-agent INCB001158
Time Frame:Up to 2 years
Safety Issue:
Description:Defined as the time from first observed response until onset of disease progression according to RECIST v1.1 or death due to any cause.
Measure:Part 1 and Part 2: Duration of response with INCMGA00012 in combination with INCB001158
Time Frame:Up to 2 years
Safety Issue:
Description:Defined as the time from first observed response until onset of disease progression according to RECIST v1.1 or death due to any cause.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Incyte Biosciences Japan GK

Trial Keywords

  • Advanced solid tumors
  • metastatic solid tumors
  • INCMGA00012
  • INCB001158
  • Japan
  • PD-1 Inhibitor
  • Arginase Inhibitor

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