Study INCB 01158-101 (formerly known as CX-1158-101) 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
Johns Hopkins Kimmel Cancer Center in Baltimore
To evaluate the safety and tolerability of CB-1158 alone and in combination with Immune Checkpoint Therapy for patients with advanced/metastatic solid tumors
Patients must be 18 years or older with confirmed metastatic or locally advanced cancer with measurable disease. Good performance status as determined by study team evaluation. Adequate laboratory values as determined at screening. Side effects from prior treatment must have resolved or stabilized. No pregnant or breast feeding females. All participants, male and female must agree to adequate birth control measures during and for a period after treatment completion. Must be able to take oral medications and receive oral or IV hydration.No other chemotherapy, TKI therapy, radiation or hormonal therapy within 2 weeks; or immunotherapy, biological therapy, or investigational agent within 3 weeks.No known or suspected exclusionary autoimmune disease.No conditions requiring systemic treatment with corticosteriods or other systemic immunosuppresive medications within 2 weeks.No valproic acid/ valproate-containing therapies, allopurinol, or other xanthine oxidase inhibitors.No history or risk of bowel perforation.No symptomatic ascites or pleural effusion.No major surgery within 28 days.No active infections within 2 weeks.Patients who have HIV, Hepatitis B or C are excluded.No active, non-stable brain metastases or CNS disease.No known deficiences or suspected defects in the urea cycle.No live-virus vaccinations within 30 days.
CB-1158 is an arginase inhibitor, and will be taken by mouth twice a day.
02/21/2020 05:03 AM