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.
Checked against the public recordLast updated Aug 5, 2025 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Incyte Corporation
- Interventions being studied
- Drug: INCB001158; Drug: Pembrolizumab
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
\*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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of South AlabamaMobile, Alabama
- Honor Health/Pinnacle Oncology HematologyScottsdale, Arizona
- University of ArizonaTucson, Arizona
- GeorgetownWashington D.C., District of Columbia
- Johns HopkinsBaltimore, Maryland
- BIDMCBoston, Massachusetts
- DFCIBoston, Massachusetts
- Henry FordDetroit, Michigan
- Sarah Cannon Research Institute at Tennessee OncologyNashville, Tennessee
- VanderbiltNashville, Tennessee
- MD AndersonHouston, Texas
- MD AndersonHouston, Texas
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 5, 2025. Always confirm current availability with the study team.