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

Sponsor
Incyte Biosciences Japan GK
Study ID
NCT03910530
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Solid Tumors
  • Metastatic Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Retifanlimab — DRUG
    Part 1: INCMGA00012 500 mg every 4 weeks administered intravenously over 60 minutes.
  • 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 .

Study Details

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.

Key Dates

Start date
Jul 22, 2019
Status verified
Feb 2022
Primary completion
Dec 14, 2021
Completion
Dec 14, 2021

Study Design

Enrollment
18 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: INCMGA00012
    Single-agent INCMGA00012.
  • Experimental: INCB001158 75 mg
    Single-agent INCB001158.
  • Experimental: INCB001158 100 mg
    Single-agent INCB001158.
  • Experimental: INCMGA00012 + INCB001158
    Combination of INCMGA00012 and INCB001158.

Primary Outcome Measure

Part 1: Number of treatment-emergent adverse events in participants receiving single-agent INCMGA00012 [ Time Frame: Up to approximately 2 years ]

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