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NOT YET RECRUITING
NCT07842965
PHASE1

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

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

Biopsy Procedure

Undergo biopsy

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Computed Tomography

Undergo CT

DRUG

Floxuridine

Given via HAI pump

PROCEDURE

Intrahepatic Infusion Procedure

Given floxuridine via HAI pump

BIOLOGICAL

Leronlimab

Given SC

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Surgical Procedure

Undergo surgical resection with HAI pump placement

PROCEDURE

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