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.
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
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
Single group
Biopsy Procedure
Procedure/SurgeryUndergo biopsy
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Computed Tomography
Procedure/SurgeryUndergo CT
Floxuridine
DrugGiven via HAI pump
Intrahepatic Infusion Procedure
Procedure/SurgeryGiven floxuridine via HAI pump
Leronlimab
Biological/VaccineGiven SC
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Surgical Procedure
Procedure/SurgeryUndergo surgical resection with HAI pump placement
Systemic Therapy
Procedure/SurgeryGiven SOC systemic therapy
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.
Incidence, type, and severity of adverse events (AEs) attributed to HAI
Will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5. Events will be summarized by frequency, system organ class, preferred term, worst grade, and attribution category. Descriptive statistics will be used to summarize the safety profile.
Incidence of serious AEs attributed to HAI
Will be graded according to CTCAE v 5. Events will be summarized by frequency, system organ class, preferred term, worst grade, and attribution category. Descriptive statistics will be used to summarize the safety profile.
Incidence of AEs attributed to HAI leading to treatment interruption or discontinuation
Will be graded according to CTCAE v 5. Events will be summarized by frequency, system organ class, preferred term, worst grade, and attribution category. Descriptive statistics will be used to summarize the safety profile.
Incidence, type, and severity of AEs attributed to leronlimab
Will be graded according to CTCAE v 5. Events will be summarized by frequency, system organ class, preferred term, worst grade, and attribution category. Descriptive statistics will be used to summarize the safety profile.
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City of Hope Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
