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

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)

Primary Outcome 1 - Timeframe: up to study completion (up to approximately 3.5 years)

CONDITION

• 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

ELIGIBILITY

*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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Emil Kuriakose, MD, Sven Gogov, MD

Role: Study Director, Study Director

Affiliation: Calithera Biosciences, Inc, Incyte Corporation

Overall Contact

Name: N/A

Phone: N/A

Email: N/A

LOCATION