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Safety, Pharmacokinetics, and Pharmacodynamics of Escalating Oral Doses of the Arginase Inhibitor INCB001158 (formerly known as CB- 1158) as a Single Agent and in Combination with Immune Checkpoint Therapy in Patients with Advanced/Metastatic Solid Tumors

Not Enrolling

Trial ID:NCT02903914

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Protocol #:17-427

877-DF-TRIAL (877-338-7425)

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


Principal Investigator:Hanna, Glenn, J

Site Investigator(s):Bullock, Andrea, J.
Lee, Richard, J.
McDermott, David, F.

Site Research Nurse(s):Baylies, Rosemarie,
Carey, Margaret, M.
Gillen Mckay, Christine, A.
Gotthardt, Susan, Jean
Kelley, Kristina,
Rowan, Jennifer, M.
Rowan, Jennifer, M.

Trial Description:
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.

Eligibility Requirements:
*Additional cohort specific criteria may apply
- 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

Protocol #: 17-427

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