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

*Additional cohort specific criteria may apply

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