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

NCT07842965 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 3 other identifiers: 25965NCI-2026-06678P30CA033572
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Proportion of patients completing all four planned hepatic arterial infusion (HAI) cycles with a relative dose intensity ≥ 80% for HIA floxuridine (FUDR)

  Will be calculated using the number of patients who complete all four planned HAI cycles with a relative dose intensity ≥ 80% for HAI FUDR divided by the total number of enrolled patients.

  Up to 4 cycles (cycle length = 28 days)

Secondary Outcomes (19)

• Incidence, type, and severity of adverse events (AEs) attributed to HAI

  From first dose HAI through 30 days after the last dose of HAI

• Incidence of serious AEs attributed to HAI

  From first dose HAI through 30 days after the last dose of HAI

• Incidence of AEs attributed to HAI leading to treatment interruption or discontinuation

  From first dose HAI through 30 days after the last dose of HAI

• Incidence, type, and severity of AEs attributed to leronlimab

  From first dose leronlimab through 30 days after last dose of leronlimab

• Incidence of serious AEs attributed to leronlimab

  From first dose leronlimab through 30 days after last dose of leronlimab

Study Arms (1)

Treatment (leronlimab, HAI FUDR, systemic therapy)

EXPERIMENTAL

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.

Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Drug: Floxuridine; Procedure: Intrahepatic Infusion Procedure; Biological: Leronlimab; Procedure: Magnetic Resonance Imaging; Procedure: Surgical Procedure; Procedure: Systemic Therapy

Interventions

Biopsy Procedure PROCEDURE

Undergo biopsy

Also known as: Biopsy, BIOPSY_TYPE, Bx

Treatment (leronlimab, HAI FUDR, systemic therapy)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

Treatment (leronlimab, HAI FUDR, systemic therapy)

Computed Tomography PROCEDURE

Undergo CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography

Treatment (leronlimab, HAI FUDR, systemic therapy)

Floxuridine DRUG

Given via HAI pump

Also known as: 2'-Deoxy-5-fluorouridine, 5-Fluoro-2'-deoxyuridine, 5-Fluorodeoxyuridine, 5-Fluorouracil deoxyriboside, 5-FUdR, FDUR, Floxuridin, Fluorodeoxyuridine, Fluorouridine Deoxyribose, Fluoruridine Deoxyribose, FUdR, WR 138720, WR-138720, WR138720

Treatment (leronlimab, HAI FUDR, systemic therapy)

Intrahepatic Infusion Procedure PROCEDURE

Given floxuridine via HAI pump

Also known as: HAI, Hepatic Arterial Infusion, Hepatic Artery Infusion, IHI, Intrahepatic Infusion

Treatment (leronlimab, HAI FUDR, systemic therapy)

Leronlimab BIOLOGICAL

Given SC

Also known as: PA14, PRO 140, PRO-140, PRO140, WHO 10751

Treatment (leronlimab, HAI FUDR, systemic therapy)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

Treatment (leronlimab, HAI FUDR, systemic therapy)

Surgical Procedure PROCEDURE

Undergo surgical resection with HAI pump placement

Also known as: Operation, Surgery, Surgery Type, Surgery, NOS, Surgical, Surgical Intervention, Surgical Interventions, Surgical Procedures, Type of Surgery

Treatment (leronlimab, HAI FUDR, systemic therapy)

Systemic Therapy PROCEDURE

Given SOC systemic therapy

Also known as: Non-targeted, Non-targeted Therapy, Systemic Treatment

Treatment (leronlimab, HAI FUDR, systemic therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented informed consent of the participant and/or legally authorized representative
• Agreement to allow the use of archival tissue from diagnostic tumor and/or surgical biopsies
• If unavailable, exceptions may be granted with study principal investigator (PI) approval
• Age: ≥ 18 years
• Eastern Cooperative Oncology Group (ECOG) ≤ 2
• Confirmed metastatic colorectal cancer with liver dominant metastases amenable and a candidate for adjuvant HAI floxuridine (FUDR) pump therapy as determined by the clinical team.
• Note: patients should be candidates for an R0/R1 complete resection of the liver metastases with the goal of ideally achievement of no evidence of disease (NED) or treated disease
• Note: peri/intra-operative interventional ablation therapy, radiation therapy, as well as liver-directed therapy to achieve NED/treated disease is allowed. Patients who are getting a liver pump only and no surgery due to unresectable liver metastases are not eligible for this study
• Hemoglobin ≥ 8 g/dL (within 14 days prior to day 1 of protocol therapy)
• NOTE: Iron replacement and/or red blood cell transfusions are permitted as long as the patient is not actively bleeding
• Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (unless has Gilbert's syndrome) (within 14 days prior to day 1 of protocol therapy)
• NOTE: If the patient has Gilbert's disease, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must be ≤ 3.0 x ULN
• AST ≤ 5.0 x ULN (within 14 days prior to day 1 of protocol therapy)
• ALT ≤ 5.0 x ULN (within 14 days prior to day 1 of protocol therapy)
• Creatinine ≤ 1.5 x institutional ULN (within 14 days prior to day 1 of protocol therapy) OR

You may not qualify if:

• Concurrent participation in another interventional study. Participation in observational clinical studies is permitted
• Chemotherapy, biological therapy, immunotherapy within 14 days or five half-lives (whichever is shorter for non-radiation therapy) prior to day 1 of protocol therapy
• Note: Radiation therapy and/or other peri/intra-operative other liver directed therapy is allowed; patients need to have sufficiently recovered from it as assessed by the treating physician or site PI
• Patients using herbal medications or supplements. These also need to be stopped 14 days prior to day 1 of protocol therapy. Exceptions are over-the-counter medications or supplements taken for supportive care (e.g., vitamins, ginseng or electrolytes for fatigue) are permitted. Participants will be advised to discuss with the study team prior to initiating any new medication or supplement during the study
• Significant comorbidities or conditions that would impede candidacy for surgery or trial participation
• Known hypersensitivity to leronlimab or components of the formulation
• Other active malignancy. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
• Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
• Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• City of Hope Medical Center: lead

Study Sites (3)

CTCA at Western Regional Medical Center

Goodyear, Arizona, 85338, United States

Location

City of Hope Medical Center

Duarte, California, 91010, United States

Location

City of Hope at Irvine Lennar

Irvine, California, 92618, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Biopsy; Specimen Handling; Floxuridine; 5-fluoro-2'-deoxyuridine; leronlimab; Magnetic Resonance Spectroscopy; Surgical Procedures, Operative; Immunity, Heterologous; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Surgical; Investigative Techniques; Deoxyuridine; Uridine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Spectrum Analysis; Chemistry Techniques, Analytical; Immunity; Immune System Phenomena; Combined Modality Therapy; Therapeutics

Study Officials

• Pashtoon M Kasi

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2026
• First Posted: September 25, 2026
• Study Start (Estimated): May 6, 2027
• Primary Completion (Estimated): February 2, 2028
• Study Completion (Estimated): February 2, 2028
• Last Updated: September 25, 2026

Record last verified: 2026-09

Locations

US (3)