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CCR5 Targeting Leronlimab in Combination With Hepatic Arterial Infusion Floxuridine and Systemic Therapy for the Treatment of Colorectal Cancer Liver Metastases, CHAMP Trial
Sponsor: City of Hope Medical Center
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
36
Start Date
2027-05-06
Completion Date
2028-02-02
Last Updated
2026-09-25
Healthy Volunteers
No
Conditions
Interventions
Biopsy Procedure
Undergo biopsy
Biospecimen Collection
Undergo blood sample collection
Computed Tomography
Undergo CT
Floxuridine
Given via HAI pump
Intrahepatic Infusion Procedure
Given floxuridine via HAI pump
Leronlimab
Given SC
Magnetic Resonance Imaging
Undergo MRI
Surgical Procedure
Undergo surgical resection with HAI pump placement
Systemic Therapy
Given SOC systemic therapy
Locations (3)
CTCA at Western Regional Medical Center
Goodyear, Arizona, United States
City of Hope Medical Center
Duarte, California, United States
City of Hope at Irvine Lennar
Irvine, California, United States