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

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ClinicalTrials.gov Identifier: NCT03910530
Recruitment Status : Not yet recruiting
First Posted : April 10, 2019
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation ( Incyte Biosciences Japan GK )

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Metastatic Solid Tumors Drug: INCMGA00012 Drug: INCB001158 Drug: INCMGA00012 + INCB001158 Phase 1

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Study Type : Interventional
Estimated Enrollment : 21 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b Study of INCMGA00012 (PD-1 Inhibitor), INCB001158 (Arginase Inhibitor), and the Combination in Japanese Participants With Advanced Solid Tumors
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Arm Intervention/treatment
Experimental: INCMGA00012
Single-agent INCMGA00012.
Drug: INCMGA00012
Part 1: INCMGA00012 500 mg every 4 weeks administered intravenously over 60 minutes.

Experimental: INCB001158 75 mg
Single-agent INCB001158.
Drug: INCB001158
Part 1: INCB001158 75 or 100 mg twice daily administered orally.

Experimental: INCB001158 100 mg
Single-agent INCB001158.
Drug: INCB001158
Part 1: INCB001158 75 or 100 mg twice daily administered orally.

Experimental: INCMGA00012 + INCB001158
Combination of INCMGA00012 and INCB001158.
Drug: INCMGA00012 + INCB001158
Part 2: INCB001158 at the recommended Phase 2 dose selected from Part 1 in combination with INCMGA00012 .




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

  2. Part 1: Number of treatment-emergent adverse events in participants receiving single-agent INCB001158 [ Time Frame: Up to approximately 2 years ]
    Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.

  3. Part 2: Number of treatment-emergent adverse events in participants receiving INCB001158 in combination with INCMGA00012 [ Time Frame: Up to approximately 2 years ]
    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 :
  1. Part 1: Cmax of single-agent INCMGA000012 [ Time Frame: Up to 15 days ]
    Maximum observed plasma or serum concentration.

  2. Part 1: Cmax of single-agent INCB001158 [ Time Frame: Up to 15 days ]
    Maximum observed plasma or serum concentration.

  3. Part 1: Tmax of single-agent INCMGA000012 [ Time Frame: Up to 15 days ]
    Time to maximum concentration.

  4. Part 1: Tmax of single-agent INCB001158 [ Time Frame: Up to 15 days ]
    Time to maximum concentration.

  5. Part 1: Cmin of single-agent INCMGA000012 [ Time Frame: Up to 15 days ]
    Minimum observed plasma or serum concentration over the dose interval.

  6. Part 1: Cmin of single-agent INCB001158 [ Time Frame: Up to 15 days ]
    Minimum observed plasma or serum concentration over the dose interval.

  7. Part 1: AUCt of single-agent INCMGA000012 [ Time Frame: Up to 15 days ]
    Area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t.

  8. Part 1: AUCt of single-agent INCB001158 [ Time Frame: Up to 15 days ]
    Area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t.

  9. Part 1: t½ of single-agent INCMGA000012 [ Time Frame: Up to 15 days ]
    Apparent terminal-phase disposition half-life.

  10. Part 1: t½ of single-agent INCB001158 [ Time Frame: Up to 15 days ]
    Apparent terminal-phase disposition half-life.

  11. Part 2: Cmax of INCMGA00012 and INCB001158 as a combination treatment [ Time Frame: Up to 15 days ]
    Maximum observed plasma or serum concentration.

  12. Part 2: Tmax of INCMGA00012 and INCB001158 as a combination treatment [ Time Frame: Up to 15 days ]
    Time to maximum concentration.

  13. Part 2: Cmin of INCMGA00012 and INCB001158 as a combination treatment [ Time Frame: Up to 15 days ]
    Minimum observed plasma or serum concentration over the dose interval.

  14. Part 2: AUCt of INCMGA00012 and INCB001158 as a combination treatment [ Time Frame: Up to 15 days ]
    Area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t.

  15. Part 2: t½ of INCMGA00012 and INCB001158 as a combination treatment [ Time Frame: Up to 15 days ]
    Apparent terminal-phase disposition half-life.

  16. Part 1 and Part 2: Overall response rate with single-agent INCMGA00012 [ Time Frame: Up to 2 years ]
    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.

  17. Part 1 and Part 2: Overall response rate with single-agent INCB001158 [ Time Frame: Up to 2 years ]
    Defined as the percentage of participants experiencing a PR or CR as determined by the investigator according to RECIST v1.1.

  18. Part 1 and Part 2: Overall response rate with INCMGA00012 in combination with INCB001158 [ Time Frame: Up to 2 years ]
    Defined as the percentage of participants experiencing a PR or CR as determined by the investigator according to RECIST v1.1.

  19. Part 1 and Part 2: Disease control rate with single-agent INCMGA00012 [ Time Frame: Up to 2 years ]
    Defined as the number of participants maintaining either an overall response rate or stable disease according to RECIST v1.1.

  20. Part 1 and Part 2: Disease control rate with single-agent INCB001158 [ Time Frame: Up to 2 years ]
    Defined as the number of participants maintaining either an overall response rate or stable disease according to RECIST v1.1.

  21. Part 1 and Part 2: Disease control rate with INCMGA00012 in combination with INCB001158 [ Time Frame: Up to 2 years ]
    Defined as the number of participants maintaining either an overall response rate or stable disease according to RECIST v1.1.

  22. Part 1 and Part 2: Duration of response with single-agent INCMGA00012 [ Time Frame: Up to 2 years ]
    Defined as the time from first observed response until onset of disease progression according to RECIST v1.1 or death due to any cause.

  23. Part 1 and Part 2: Duration of response with single-agent INCB001158 [ Time Frame: Up to 2 years ]
    Defined as the time from first observed response until onset of disease progression according to RECIST v1.1 or death due to any cause.

  24. Part 1 and Part 2: Duration of response with INCMGA00012 in combination with INCB001158 [ Time Frame: Up to 2 years ]
    Defined as the time from first observed response until onset of disease progression according to RECIST v1.1 or death due to any cause.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03910530


Contacts
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Contact: Incyte Biosciences Japan GK Development Operations +81 3-3507-5795 japan_clinicaltrials@incyte.com

Locations
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Japan
National Cancer Center Hospital Not yet recruiting
Chuo Ku, Japan, 1040045
National Cancer Center Hospital East Not yet recruiting
Kashiwa, Japan, 277-8577
Sponsors and Collaborators
Incyte Biosciences Japan GK
Investigators
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Study Director: Eiji Ueda, MD, PhD, MBA Incyte Biosciences Japan GK

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Responsible Party: Incyte Biosciences Japan GK
ClinicalTrials.gov Identifier: NCT03910530     History of Changes
Other Study ID Numbers: INCMGA 0012-104
First Posted: April 10, 2019    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Incyte Corporation ( Incyte Biosciences Japan GK ):
Advanced solid tumors
metastatic solid tumors
INCMGA00012
INCB001158
Japan
PD-1 Inhibitor
Arginase Inhibitor

Additional relevant MeSH terms:
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Neoplasms
CB-1158
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action