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Clinical Trials Search at Vanderbilt-Ingram Cancer Center

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

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.
Not Available
Phase I
Not Available
Not Available
Gibson, Mike
Vanderbilt University


18 Years
Inclusion Criteria:

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

Exclusion 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

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