CCR5 Targeting Leronlimab in Combination With Hepatic Arterial Infusion Floxuridine and Systemic Therapy for the Treatment of Colorectal Cancer Liver Metastases, CHAMP Trial
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)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 6 weeks, 24 months
- Procedures mentioned: Infusions, Blood draws, MRI scans, CT scans, Biopsies
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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)."
- "To evaluate the feasibility of administering four planned cycles of combined standard-of-care systemic therapy, hepatic arterial infusion (HAI) floxuridine (FUDR), and leronlimab as reflected by relative dose intensity in the study population."
- "OUTLINE: Patients receive leronlimab subcutaneously (SC) weekly with SOC systemic therapy for up to 6 weeks in the absence of disease progression or unacceptable toxicity."
- "Patients also undergo blood sample collection and computed tomography (CT) and/or magnetic resonance imaging (MRI) throughout the study."
- "Additionally, patients may optionally undergo biopsy on study."
- "After completion of study treatment, patients are followed up at 30 days and then for up to 24 months."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This early-stage study tests leronlimab with floxuridine chemotherapy sent directly to the liver through a pump, plus standard treatment that travels through the body. It looks at the effects and safety of this treatment. It is for adults with colon or rectal cancer that has spread mainly to the liver and can be treated with surgery and a liver pump.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be 18 or older and give written consent, yourself or through a legal representative.
- Agree to let researchers use stored tumor samples, unless the study leader approves an exception.
- Be able to care for yourself and be out of bed or a chair for at least half of your waking hours.
- Have cancer from the colon or rectum that has spread mainly to the liver.
- Be able to have surgery to remove the liver tumors and receive floxuridine through a liver pump. Other treatments aimed at the liver may also be used. A pump without surgery is not enough to qualify.
- Meet the study's blood count, liver, and kidney test limits. Tests must be done within 14 days before treatment starts.
- Have a negative pregnancy test within 14 days before treatment starts if you could become pregnant.
- If you or your partner could become pregnant, use effective birth control or avoid sex that could cause pregnancy during the study and for at least 3 months after the last dose.
Who can't join
- Taking part in another study that gives a treatment. Studies that only observe patients are allowed.
- Having chemotherapy, biological therapy, or immune treatment too recently before study treatment. The waiting time is 14 days or the time for most of the drug to leave the body, whichever is shorter.
- Not stopping herbal medicines or supplements at least 14 days before treatment. Some nonprescription products used to ease symptoms are allowed.
- Having a major health problem that prevents surgery or makes the study unsafe, or not recovering enough from recent liver treatment.
- Having a known allergy to leronlimab or any of its ingredients.
- Having another active cancer, unless it would not affect the study's safety or treatment results.
- Being unable, in the study doctor's view, to follow all study steps, including because of travel or scheduling problems.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * 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 * Creatinine clearance ≥ 50 mL/min calculated by the Cockcroft-Gault method * Women of childbearing potential (WOCBP): negative urine or serum pregnancy test (within 14 days prior to day 1 of protocol therapy) * If the urine test is positive or cannot be confirmed as negative, a qualitative or quantitative serum pregnancy test will be required * Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least three months after the last dose of protocol therapy * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only) Exclusion Criteria: * 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)
Study sites (3)
AZ
- CTCA at Western Regional Medical Center · Goodyear, AZ 85338Pashtoon M. Kasi · Study contact · 949-671-4673 · kasi@coh.orgPashtoon M. Kasi · Principal investigatorMore trials in Goodyear
CA
- City of Hope Medical Center · Duarte, CA 91010Pashtoon M. Kasi · Study contact · 949-671-4673 · kasi@coh.orgPashtoon M. Kasi · Principal investigatorMore trials in Duarte
- City of Hope at Irvine Lennar · Irvine, CA 92618Pashtoon M. Kasi · Study contact · 949-671-4673 · kasi@coh.orgPashtoon M. Kasi · Principal investigatorMore trials in Irvine