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

NCT03910530 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2022-02-25

No results posted yet for this study

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

Interventions

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 .

Sponsors & Collaborators

  • Incyte Biosciences Japan GK

    lead INDUSTRY

Principal Investigators

  • Eiji Ueda, MD, PhD, MBA · Incyte Biosciences Japan GK

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-22
Primary Completion
2021-12-14
Completion
2021-12-14
FDA Drug
Yes

Countries

  • Japan

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03910530 on ClinicalTrials.gov