A Phase 1/1b Single Arm Safety Lead in Study of Leronlimab (CCR5 Blockade) With Hepatic Arterial Infusion Pump Therapy Delivering Floxuridine (FUDR) and Concurrent Systemic Therapy in Colorectal Cancer Liver Metastases Patients (CHAMP)

Summary

This phase I/Ib trial tests the effect of leronlimab in combination with hepatic arterial infusion (HAI) floxuridine (FUDR)and standard of care (SOC) systemic therapy in treating patients with colorectal cancer that has spread from where it first started to the liver (metastatic). Leronlimab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets, such as CCR5 which is expressed on T cells (a type of immune cell), which may cause the body to make an immune response (antigens) and may also improve the effectiveness of treatment. HAI delivers chemotherapy, such as floxuridine, directly to the liver. Catheters are put into an artery in the groin that leads directly to the liver and drugs are given through the catheters. Floxuridine is in a class of medications called antimetabolites. It works by slowing or stopping the growth of tumor cells in your body. HAI can deliver floxuridine at up to 300 times the concentrations that can be given through the vein. Systemic therapy is treatment using substances that travel through the bloodstream, reaching and affecting cells all over the body. Giving leronlimab in combination with HAI floxuridine and SOC systemic therapy may be safe, tolerable, and/or safe in treating colorectal cancer patients with liver metastases.

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