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

Completed · Phase 1

Conditions studied: Metastatic Cancer, Solid Tumors, Colorectal Cancer (CRC), Gastric Cancer, Head and Neck Cancer, Lung Cancer, Renal Cell Carcinoma (RCC), Bladder Cancer, UC (Urothelial Cancer), Mesothelioma

In brief

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.

Key facts

Study ID

NCT02903914

Run by

Incyte Corporation

People needed

260

Starts

2016-09-14

Expected to finish

2022-08-15

Last updated by the study team

2025-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of South Alabama — Mobile, Alabama, United States
• Honor Health/Pinnacle Oncology Hematology — Scottsdale, Arizona, United States
• University of Arizona — Tucson, Arizona, United States
• Georgetown — Washington D.C., District of Columbia, United States
• Johns Hopkins — Baltimore, Maryland, United States
• BIDMC — Boston, Massachusetts, United States
• DFCI — Boston, Massachusetts, United States
• Henry Ford — Detroit, Michigan, United States
• Sarah Cannon Research Institute at Tennessee Oncology — Nashville, Tennessee, United States
• Vanderbilt — Nashville, Tennessee, United States
• MD Anderson — Houston, Texas, United States
• MD Anderson — Houston, Texas, United States
• START — San Antonio, Texas, United States
• Ospedale San Raffaele — Milan, Italy
• Oncologica Azienda Ospedaliera Universitaria Senese — Siena, Italy
• NKI — Amsterdam, Netherlands
• Radboudumc — Nijmegen, Netherlands
• Hospital Universitari Vall d'Hebron — Barcelona, Spain
• Institut Catala d'Oncologia — Barcelona, Spain
• START Madrid-HM CIOCC — Madrid, Spain

Full record on ClinicalTrials.gov

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