CCR5 Targeting Leronlimab in Combination With Hepatic Arterial Infusion Floxuridine and Systemic Therapy for the Treatment of Colorectal Cancer Liver Metastases, CHAMP Trial

Part of paid clinical trials in Goodyear, Arizona.

Sponsor
City of Hope Medical Center
Study ID
NCT07842965
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Metastatic Colorectal Carcinoma
  • Metastatic Malignant Neoplasm in the Liver
  • Stage IV Colorectal Cancer AJCC v8

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biopsy Procedure — PROCEDURE
    Undergo biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Floxuridine — DRUG
    Given via HAI pump
  • Intrahepatic Infusion Procedure — PROCEDURE
    Given floxuridine via HAI pump
  • Leronlimab — BIOLOGICAL
    Given SC
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Surgical Procedure — PROCEDURE
    Undergo surgical resection with HAI pump placement
  • Systemic Therapy — PROCEDURE
    Given SOC systemic therapy

Study Details

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.

Key Dates

First listed
Sep 25, 2026
Start date
May 6, 2027
Status verified
Sep 2026
Primary completion
Feb 2, 2028
Completion
Feb 2, 2028

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (leronlimab, HAI FUDR, systemic therapy)
    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.

Primary Outcome Measure

Proportion of patients completing all four planned hepatic arterial infusion (HAI) cycles with a relative dose intensity ≥ 80% for HIA floxuridine (FUDR) [ Time Frame: Up to 4 cycles (cycle length = 28 days) ]

Locations (3)

FacilityCityStateZIPSite coordinators
CTCA at Western Regional Medical CenterGoodyearArizona85338
Pashtoon M. Kasi
[email protected]
949-671-4673
Pashtoon M. Kasi (PRINCIPAL_INVESTIGATOR)
City of Hope Medical CenterDuarteCalifornia91010
Pashtoon M. Kasi
[email protected]
949-671-4673
Pashtoon M. Kasi (PRINCIPAL_INVESTIGATOR)
City of Hope at Irvine LennarIrvineCalifornia92618
Pashtoon M. Kasi
[email protected]
949-671-4673
Pashtoon M. Kasi (PRINCIPAL_INVESTIGATOR)

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By research site
CTCA at Western Regional Medical Center· Goodyear, AZCity of Hope Medical Center· Duarte, CACity of Hope at Irvine Lennar· Irvine, CA

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