Last updated on July 2020

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Squamous Cell Carcinoma of the Head and Neck | Ulcerative Colitis (Pediatric) | Renal Cell Carcinoma | Rectal disorder | Mesothelioma | Pulmonary Disease | Transitional cell carcinoma | Renal Cell Cancer | Bladder Carcinoma | Colon Cancer Screening | Colon cancer; rectal cancer | Adenocarcinoma | bladder disorder | Urothelial Cancer | urinary tract neoplasm | Rectal Disorders | Lung Disease | Stomach Cancer | Solid Tumors | Brain Metastases | Neoplasm Metastasis | Liver Metastases | Urologic Cancer | Kidney Cancer | Metastatic Cancer | Non-Small Cell Lung Cancer | Stomach Discomfort | Ulcerative Colitis | Malignant neoplasm of kidney | Gastropathy | head and neck cancer | Urothelial Carcinoma | Bladder Disorders | Lung Neoplasm | Metastasis | Malignant Adenoma | Colorectal Cancer | Bone Metastases | Gastric Cancer | Bronchial Neoplasm | Renal Cancer | bladder cancer | UC | Lung Cancer
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

*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

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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