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