Leronlimab + Floxuridine for Colorectal Cancer Liver Metastases
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Pashtoon M Kasi
Principal Investigator
City of Hope Medical Center
Are You a Good Fit for This Trial?
This trial is for adults with colorectal cancer that has spread to the liver. Participants should be healthy enough for surgery and treatment, and able to undergo procedures like biopsies and imaging scans.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Floxuridine
- Leronlimab
Trial Overview
The study tests leronlimab (an immune-targeting antibody) combined with chemotherapy delivered directly to the liver (floxuridine via hepatic arterial infusion), plus standard treatments. The goal is to see if this combination is safe and effective.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients receive leronlimab SC weekly with SOC systemic therapy for up to 6 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo surgical resection with HAI pump placement. Starting 4 weeks after surgery, patients receive floxuridine continuously via HAI pump every 14 days of each cycle and resume leronlimab SC weekly in combination with SOC systemic therapy of each cycle. Cycles repeat every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection and CT and/or MRI throughout the study. Additionally, patients may optionally undergo biopsy on study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
City of Hope Medical Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
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