CCR5靶向药物Leronlimab联合肝动脉灌注氟尿苷及全身治疗用于结直肠癌肝转移的CHAMP试验

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

Interventions: procedure: Biopsy Procedure (Biopsy, BIOPSY_TYPE, Bx); procedure: Biospecimen Collection (Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection); procedure: Computed Tomography (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); drug: Floxuridine (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); procedure: Intrahepatic Infusion Procedure (HAI, Hepatic Arterial Infusion, Hepatic Artery Infusion, IHI, Intrahepatic Infusion); biological: Leronlimab (PA14, PRO 140, PRO-140, PRO140, WHO 10751); procedure: Magnetic Resonance Imaging (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); procedure: Surgical Procedure (Operation, Surgery, Surgery Type, Surgery, NOS, Surgical, Surgical Intervention, Surgical Interventions, Surgical Procedures, Type of Surgery); procedure: Systemic Therapy (Non-targeted, Non-targeted Therapy, Systemic Treatment)

Phase: Phase 1

Enrollment: 36 (estimated)

Sponsor: City of Hope Medical Center (other)

Countries: United States

Status: not yet recruiting