Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Retifanlimab | Drug | Part 1: INCMGA00012 500 mg every 4 weeks administered intravenously over 60 minutes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Number of treatment-emergent adverse events in participants receiving single-agent INCMGA00012 | Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug. | Up to approximately 2 years |
| Part 1: Number of treatment-emergent adverse events in participants receiving single-agent INCB001158 | Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug. | Up to approximately 2 years |
| Part 2: Number of treatment-emergent adverse events in participants receiving INCB001158 in combination with INCMGA00012 | Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug. | Up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Cmax of single-agent INCMGA000012 | Maximum observed plasma or serum concentration. | Up to 15 days |
| Part 1: Cmax of single-agent INCB001158 | Maximum observed plasma or serum concentration. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eiji Ueda, MD, PhD, MBA | Incyte Biosciences Japan GK | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center Hospital | Chūōku | 1040045 | Japan | |||
| National Cancer Center Hospital East |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| INCB001158 | Drug | Part 1: INCB001158 75 or 100 mg twice daily administered orally. |
|
| Retifanlimab + INCB001158 | Drug | Part 2: INCB001158 at the recommended Phase 2 dose selected from Part 1 in combination with INCMGA00012 . |
|
|
| Up to 15 days |
| Part 1: Tmax of single-agent INCMGA000012 | Time to maximum concentration. | Up to 15 days |
| Part 1: Tmax of single-agent INCB001158 | Time to maximum concentration. | Up to 15 days |
| Part 1: Cmin of single-agent INCMGA000012 | Minimum observed plasma or serum concentration over the dose interval. | Up to 15 days |
| Part 1: Cmin of single-agent INCB001158 | Minimum observed plasma or serum concentration over the dose interval. | Up to 15 days |
| Part 1: AUCt of single-agent INCMGA000012 | Area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t. | Up to 15 days |
| Part 1: AUCt of single-agent INCB001158 | Area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t. | Up to 15 days |
| Part 1: t½ of single-agent INCMGA000012 | Apparent terminal-phase disposition half-life. | Up to 15 days |
| Part 1: t½ of single-agent INCB001158 | Apparent terminal-phase disposition half-life. | Up to 15 days |
| Part 2: Cmax of INCMGA00012 and INCB001158 as a combination treatment | Maximum observed plasma or serum concentration. | Up to 15 days |
| Part 2: Tmax of INCMGA00012 and INCB001158 as a combination treatment | Time to maximum concentration. | Up to 15 days |
| Part 2: Cmin of INCMGA00012 and INCB001158 as a combination treatment | Minimum observed plasma or serum concentration over the dose interval. | Up to 15 days |
| Part 2: AUCt of INCMGA00012 and INCB001158 as a combination treatment | Area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t. | Up to 15 days |
| Part 2: t½ of INCMGA00012 and INCB001158 as a combination treatment | Apparent terminal-phase disposition half-life. | Up to 15 days |
| Part 1 and Part 2: Overall response rate with single-agent INCMGA00012 | 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. | Up to 2 years |
| Part 1 and Part 2: Overall response rate with single-agent INCB001158 | Defined as the percentage of participants experiencing a PR or CR as determined by the investigator according to RECIST v1.1. | Up to 2 years |
| Part 1 and Part 2: Overall response rate with INCMGA00012 in combination with INCB001158 | Defined as the percentage of participants experiencing a PR or CR as determined by the investigator according to RECIST v1.1. | Up to 2 years |
| Part 1 and Part 2: Disease control rate with single-agent INCMGA00012 | Defined as the number of participants maintaining either an overall response rate or stable disease according to RECIST v1.1. | Up to 2 years |
| Part 1 and Part 2: Disease control rate with single-agent INCB001158 | Defined as the number of participants maintaining either an overall response rate or stable disease according to RECIST v1.1. | Up to 2 years |
| Part 1 and Part 2: Disease control rate with INCMGA00012 in combination with INCB001158 | Defined as the number of participants maintaining either an overall response rate or stable disease according to RECIST v1.1. | Up to 2 years |
| Part 1 and Part 2: Duration of response with single-agent INCMGA00012 | Defined as the time from first observed response until onset of disease progression according to RECIST v1.1 or death due to any cause. | Up to 2 years |
| Part 1 and Part 2: Duration of response with single-agent INCB001158 | Defined as the time from first observed response until onset of disease progression according to RECIST v1.1 or death due to any cause. | Up to 2 years |
| Part 1 and Part 2: Duration of response with INCMGA00012 in combination with INCB001158 | Defined as the time from first observed response until onset of disease progression according to RECIST v1.1 or death due to any cause. | Up to 2 years |
| Kashiwa |
| 277-8577 |
| Japan |