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.
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
Drug | Synonyms | Arms |
---|
Retifanlimab | INCMGA00012 | INCMGA00012 |
INCB001158 | | INCB001158 100 mg |
Retifanlimab + INCB001158 | INCMGA00012 | INCMGA00012 + 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
Name | Type | Description | Interventions |
---|
INCMGA00012 | Experimental | Single-agent INCMGA00012. | |
INCB001158 75 mg | Experimental | Single-agent INCB001158. | |
INCB001158 100 mg | Experimental | Single-agent INCB001158. | |
INCMGA00012 + INCB001158 | Experimental | Combination of INCMGA00012 and INCB001158. | - Retifanlimab + 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: | Active, not recruiting |
Lead Sponsor: | Incyte Biosciences Japan GK |
Trial Keywords
- Advanced solid tumors
- metastatic solid tumors
- INCMGA00012
- INCB001158
- Japan
- PD-1 Inhibitor
- Arginase Inhibitor
Last Updated
June 16, 2021