NCT03910530

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Incyte Biosciences Japan GK · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Solid Tumors
• Metastatic Solid Tumors

Interventions

Type	Name	Description
DRUG	Retifanlimab	Part 1: INCMGA00012 500 mg every 4 weeks administered intravenously over 60 minutes.
DRUG	INCB001158	Part 1: INCB001158 75 or 100 mg twice daily administered orally.
DRUG	Retifanlimab + INCB001158	Part 2: INCB001158 at the recommended Phase 2 dose selected from Part 1 in combination with INCMGA00012 .

Timeline

• Start date: 2019-07-22
• Primary completion: 2021-12-14
• Completion: 2021-12-14
• First posted: 2019-04-10
• Last updated: 2022-02-25

Locations

2 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study