|Principal Investigator/ Physician||Sachin Pai, MD|
|Protocol No.||INCB 01158-101|
|Cancer Site||Solid Tumor|
|Contact Email||MCI Clinical Trials|
Protocol Title: 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.
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, 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 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 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.
Clinical Trials.Gov Link: https://clinicaltrials.gov/ct2/show/NCT02903914?term=INCB+01158-101&rank=1
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