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CompletedPhase 1NCT02903914
Official study title

Arginase Inhibitor INCB001158 as a Single Agent and in Combination With Immune Checkpoint Therapy in Patients With Advanced/Metastatic Solid Tumors

Study summary

This study is an open-label Phase 1/Phase 2 evaluation of INCB001158 as a single agent and in combination with immune checkpoint therapy in patients with advanced/metastatic solid tumors.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedINCB001158 and Pembrolizumab

The study team can explain what participation involves.

Who it may be forMesothelioma · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Aug 5, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?20 U.S. locations

Locations may change over time.

Who runs it?Incyte Corporation

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Incyte Corporation
Interventions being studied
Drug: INCB001158; Drug: Pembrolizumab
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Mesothelioma→
Disease setting
Metastatic or stage IV→
Treatment approach
Immunotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • \*Additional cohort specific criteria may apply
  • Must be age 18 or older
  • Ability to provide written informed consent in accordance with federal, local, and institutional guidelines
  • Histological or cytological diagnosis of metastatic cancer or locally advanced cancer that is not amenable to local therapy
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
  • Life Expectancy of at least 3 months
  • Adequate hepatic, renal (moderately impaired renal function in cohort 1c only), cardiac, and hematologic function
  • Measurable disease by RECISTv1.1 criteria
  • Resolution of treatment-related toxicities
  • Willingness to avoid pregnancy or fathering children
  • Prior anti-PD-1 treatment for combination dose expansion cohorts 1c, 3a - 3d
Reasons someone may not be able to joinExclusion criteria
  • Currently pregnant or lactating
  • Unable to receive oral medications
  • Unable to receive oral or IV hydration
  • Intolerance to prior anti-PD-1/PD-L1 therapy
  • Prior anti-PD-1 treatment for combination dose expansion cohorts 1c, 3e - 3h
  • Prior severe hypersensitivity reaction to another monoclonal antibody (mAb)
  • Any other current or previous malignancy within 3 years except protocol allowed malignancies
  • Chemotherapy, Tyrosine Kinase Inhibitor therapy, radiation therapy or hormonal therapy within 2 weeks
  • Immunotherapy or biological therapy, or investigational agent within 3 weeks (Note: some cohort exceptions allow anti-PD-1 therapy)
  • Active known or suspected exclusionary autoimmune disease
  • Any condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other systemic immunosuppressive medications within 2 weeks
  • Concomitant therapy with valproic acid/valproate-containing therapies
  • Concomitant therapy with allopurinol and other xanthine oxidase inhibitors
  • History of known risks factors for bowel perforation
  • Symptomatic ascites or pleural effusion
  • Major surgery within 28 days before Cycle 1 Day 1
  • Active infection requiring within 2 weeks prior to first dose of study drug
  • Patients who have HIV, Hepatitis B or C
  • Conditions that could interfere with treatment or protocol-related procedures
  • Active, non-stable brain metastases or CNS disease
  • Known deficiencies or suspected defect in the urea cycle
  • Received live-virus vaccination within 30 days (seasonal flu vaccine allowed if non-live virus)
  • NSCLC with EGFR or ALK mutation

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of South AlabamaMobile, Alabama
  • Honor Health/Pinnacle Oncology HematologyScottsdale, Arizona
  • University of ArizonaTucson, Arizona
  • GeorgetownWashington D.C., District of Columbia
  • Johns HopkinsBaltimore, Maryland
  • BIDMCBoston, Massachusetts
  • DFCIBoston, Massachusetts
  • Henry FordDetroit, Michigan
  • Sarah Cannon Research Institute at Tennessee OncologyNashville, Tennessee
  • VanderbiltNashville, Tennessee
  • MD AndersonHouston, Texas
  • MD AndersonHouston, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 5, 2025. Always confirm current availability with the study team.

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