Metastatic Colorectal CarcinomaPhase 1NCT07842965
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 study testing Biopsy Procedure, Biospecimen Collection and Computed Tomography in people with Metastatic Colorectal Carcinoma and Metastatic Malignant Neoplasm in the Liver, run by City of Hope Medical Center at 3 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Carcinoma, Metastatic Malignant Neoplasm in the Liver, Stage IV Colorectal Cancer AJCC v8
- What is being tested?
- Biopsy Procedure, Biospecimen Collection and Computed Tomography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 3 sitesUnited States
- Study dates
- 6 May 2027to 2 Feb 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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)
Who cannot join
- 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
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- 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)
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
City of Hope Medical Center
Duarte, California, 91010
Pashtoon M. Kasi, 949-671-4673, kasi@coh.org
Pashtoon M. Kasi
CTCA at Western Regional Medical Center
Goodyear, Arizona, 85338
Pashtoon M. Kasi, 949-671-4673, kasi@coh.org
Pashtoon M. Kasi
City of Hope at Irvine Lennar
Irvine, California, 92618
Pashtoon M. Kasi, 949-671-4673, kasi@coh.org
Pashtoon M. Kasi
About this study
Official title: 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)
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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.
SECONDARY OBJECTIVES:
- To characterize the safety profile of the combined regimen. II. To evaluate the anti-tumor activity of leronlimab administered subcutaneously alongside HAI pump and systemic therapy in patients with colorectal cancer with liver metastases, as assessed by 1 year and 2 year progression-free survival (PFS) and median progression free-survival.
III. To evaluate liver-specific disease control with leronlimab plus HAI pump and systemic therapy.
IV. To evaluate the anti-tumor activity of Leronlimab administered subcutaneously alongside HAI pump and systemic therapy in patients with colorectal cancer with liver metastases, as assessed by changes in circulating tumor deoxyribonucleic acid (DNA) (ctDNA) and ctDNA clearance.
EXPLORATORY OBJECTIVES:
- To characterize baseline and on-treatment tissue and circulatory biomarkers of immune evasion and metastatic potential, including PD-L1 expression, immune genomic and phenotypic biomarkers, and circulating tumor cells.
II. To assess liver damage and healing associated with leronlimab plus HAI pump and systemic therapy.
III. To evaluate standard-of-care imaging findings and liver parenchyma for evidence of liver damage and disease progression.
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 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 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.
- Conditions
- Metastatic Colorectal Carcinoma, Metastatic Malignant Neoplasm in the Liver, Stage IV Colorectal Cancer AJCC v8
- Being tested
- Biopsy Procedure, Biospecimen Collection, Computed Tomography, Floxuridine, Intrahepatic Infusion Procedure
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsy ProcedureProcedure or surgery
Also called Biopsy, BIOPSY_TYPE, Bx
Undergo biopsy
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Undergo blood sample collection
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT
FloxuridineDrug
Also called 2'-Deoxy-5-fluorouridine, 5-Fluoro-2'-deoxyuridine, 5-Fluorodeoxyuridine, 5-Fluorouracil deoxyriboside
Given via HAI pump
Intrahepatic Infusion ProcedureProcedure or surgery
Also called HAI, Hepatic Arterial Infusion, Hepatic Artery Infusion, IHI
Given floxuridine via HAI pump
LeronlimabBiological
Also called PA14, PRO 140, PRO-140, PRO140
Given SC
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan
Undergo MRI
Surgical ProcedureProcedure or surgery
Also called Operation, Surgery, Surgery Type, Surgery, NOS
Undergo surgical resection with HAI pump placement
Systemic TherapyProcedure or surgery
Also called Non-targeted, Non-targeted Therapy, Systemic Treatment
Given SOC systemic therapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 4 cycles (cycle length = 28 days)
Secondary outcomes (19)
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.
Measured: From first dose HAI through 30 days after the last dose of HAI
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.
Measured: 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
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.
Measured: From first dose HAI through 30 days after the last dose of HAI
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.
Measured: From first dose leronlimab through 30 days after last dose of leronlimab
Incidence of serious 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.
Measured: From first dose leronlimab through 30 days after last dose of leronlimab
Incidence of AEs leading attributed to leronlimab 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.
Measured: From first dose leronlimab through 30 days after last dose of leronlimab
Incidence, type, and severity of AEs attributed to systemic therapy
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.
Measured: From first dose systemic therapy through 30 days after last dose of systemic therapy
Incidence of serious AEs attributed to systemic therapy
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.
Measured: From first dose systemic therapy through 30 days after last dose of systemic therapy
Incidence of AEs attributed to systemic therapy leading to treatment interruption or discontuation
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.
Measured: From first dose systemic therapy through 30 days after last dose of systemic therapy
Incidence and extent of liver toxicity attributed to HAI/FUDR requiring dose reductions based on standard of care nomogram
Data will be summarized by incidence, indication, dose delays, dose interruptions, additional intraarterial corticosteroid doses administered, duration of additional intraarterial corticosteroid therapy, and association with treatment hold, dose reduction, or permanent discontinuation of HAI/FUDR. Descriptive statistics will be used to summarize the safety profile.
Measured: From the first HAI infusion through 30 days after the final dose of HAI therapy
Incidence and characteristics of dose reductions and treatment interruption of HAI/FUDR therapy
Dose reductions will be summarized by incidence, number of dose reductions per patient, time to first dose reduction, primary reason for dose reduction, and lowest dose level reached and whether treatment was subsequently discontinued. Descriptive statistics will be used to summarize the safety profile.
Measured: From first administration of HAI therapy and up through 30 days after the final administration of HAI therapy
Radiographic progression free survival (PFS)
Will be evaluated per Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1. Will be summarized as the proportion of patients who meet definition. Will be graphically represented using Kaplan-Meier methods.
Measured: From enrollment to first objective occurrence of tumor progression or death due to any cause, whichever occurs first, assessed up to 1 year
Radiographic PFS
Will be assessed using RECIST v 1.1. Will be summarized as the proportion of patients who meet the definition. Will be graphically represented using Kaplan-Meier methods.
Measured: From enrollment to first objective occurrence of tumor progression or death due to any cause, whichever occurs first, assessed up to 2 years
Median PFS
Will be graphically represented using Kaplan-Meier methods.
Measured: Up to 24 months
Median liver-PFS
Will be graphically represented using Kaplan-Meier methods.
Measured: Up to 24 months
Liver-PFS
Will be graphically represented using Kaplan-Meier methods.
Measured: From enrollment to the first occurrence of radiographic progression within the liver or death due to any cause, assessed up to 1 year
Liver-PFS
Will be graphically represented using Kaplan-Meier methods.
Measured: From enrollment to the first occurrence of radiographic progression within the liver or death due to any cause, assessed up to 2 years
Change in circulating tumor deoxyribonucleic acid (ctDNA)
Change in ctDNA will be quantified as the difference between the baseline value and each subsequent measurement. Proportion achieving clearance defined as 100% reduction in the ctDNA will also be reported. Will be quantitatively assessed to determine their correlation with clinical outcomes/findings.
Measured: At baseline (weeks 0, 2, 4, and 6) and post operatively (weeks 2, 4, 6, 8, 10, 12, 14 and 16)
ctDNA clearance
Will be quantitatively assessed to determine their correlation with clinical outcomes/findings
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start6 May 2027 (estimated)
- Primary completion2 Feb 2028 (estimated)
- Study completion2 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CarcinomaStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Pashtoon M Kasi, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07842965
- Sponsor's protocol ID
- 25965
- Other IDs
- NCI-2026-06678, 25965, P30CA033572
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07842965
- Acronym / sponsor ID
- 25965
- Conditions
- Metastatic Colorectal Carcinoma, Metastatic Malignant Neoplasm in the Liver, Stage IV Colorectal Cancer AJCC v8
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 6 May 2027 (estimated)
- Primary completion
- 2 Feb 2028 (estimated)
- Study completion
- 2 Feb 2028 (estimated)
- First posted
- 25 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- 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.
SECONDARY OBJECTIVES:
- To characterize the safety profile of the combined regimen. II. To evaluate the anti-tumor activity of leronlimab administered subcutaneously alongside HAI pump and systemic therapy in patients with colorectal cancer with liver metastases, as assessed by 1 year and 2 year progression-free survival (PFS) and median progression free-survival.
III. To evaluate liver-specific disease control with leronlimab plus HAI pump and systemic therapy.
IV. To evaluate the anti-tumor activity of Leronlimab administered subcutaneously alongside HAI pump and systemic therapy in patients with colorectal cancer with liver metastases, as assessed by changes in circulating tumor deoxyribonucleic acid (DNA) (ctDNA) and ctDNA clearance.
EXPLORATORY OBJECTIVES:
- To characterize baseline and on-treatment tissue and circulatory biomarkers of immune evasion and metastatic potential, including PD-L1 expression, immune genomic and phenotypic biomarkers, and circulating tumor cells.
II. To assess liver damage and healing associated with leronlimab plus HAI pump and systemic therapy.
III. To evaluate standard-of-care imaging findings and liver parenchyma for evidence of liver damage and disease progression.
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 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (leronlimab, HAI FUDR, systemic therapy) | Experimental | 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 TherapyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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
- 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.
Key exclusion criteria (9 listed)
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biopsy ProcedureAlso: Biopsy, BIOPSY_TYPE, BxUndergo biopsy | Procedure or surgery | Treatment (leronlimab, HAI FUDR, systemic therapy) |
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Treatment (leronlimab, HAI FUDR, systemic therapy) |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo CT | Procedure or surgery | Treatment (leronlimab, HAI FUDR, systemic therapy) |
| FloxuridineAlso: 2'-Deoxy-5-fluorouridine, 5-Fluoro-2'-deoxyuridine, 5-Fluorodeoxyuridine, 5-Fluorouracil deoxyribosideGiven via HAI pump | Drug | Treatment (leronlimab, HAI FUDR, systemic therapy) |
| Intrahepatic Infusion ProcedureAlso: HAI, Hepatic Arterial Infusion, Hepatic Artery Infusion, IHIGiven floxuridine via HAI pump | Procedure or surgery | Treatment (leronlimab, HAI FUDR, systemic therapy) |
| LeronlimabAlso: PA14, PRO 140, PRO-140, PRO140Given SC | Biological | Treatment (leronlimab, HAI FUDR, systemic therapy) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging ScanUndergo MRI | Procedure or surgery | Treatment (leronlimab, HAI FUDR, systemic therapy) |
| Surgical ProcedureAlso: Operation, Surgery, Surgery Type, Surgery, NOSUndergo surgical resection with HAI pump placement | Procedure or surgery | Treatment (leronlimab, HAI FUDR, systemic therapy) |
| Systemic TherapyAlso: Non-targeted, Non-targeted Therapy, Systemic TreatmentGiven SOC systemic therapy | Procedure or surgery | Treatment (leronlimab, HAI FUDR, systemic therapy) |
Primary outcome
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)
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.
19 secondary outcomes
Incidence, type, and severity of adverse events (AEs) attributed to HAI
Time frame: From first dose HAI through 30 days after the last dose of HAI
Incidence of serious AEs attributed to HAI
Time frame: 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
Time frame: From first dose HAI through 30 days after the last dose of HAI
Incidence, type, and severity of AEs attributed to leronlimab
Time frame: From first dose leronlimab through 30 days after last dose of leronlimab
Incidence of serious AEs attributed to leronlimab
Time frame: From first dose leronlimab through 30 days after last dose of leronlimab
Incidence of AEs leading attributed to leronlimab to treatment interruption or discontinuation
Time frame: From first dose leronlimab through 30 days after last dose of leronlimab
Incidence, type, and severity of AEs attributed to systemic therapy
Time frame: From first dose systemic therapy through 30 days after last dose of systemic therapy
Incidence of serious AEs attributed to systemic therapy
Time frame: From first dose systemic therapy through 30 days after last dose of systemic therapy
Incidence of AEs attributed to systemic therapy leading to treatment interruption or discontuation
Time frame: From first dose systemic therapy through 30 days after last dose of systemic therapy
Incidence and extent of liver toxicity attributed to HAI/FUDR requiring dose reductions based on standard of care nomogram
Time frame: From the first HAI infusion through 30 days after the final dose of HAI therapy
Incidence and characteristics of dose reductions and treatment interruption of HAI/FUDR therapy
Time frame: From first administration of HAI therapy and up through 30 days after the final administration of HAI therapy
Radiographic progression free survival (PFS)
Time frame: From enrollment to first objective occurrence of tumor progression or death due to any cause, whichever occurs first, assessed up to 1 year
Radiographic PFS
Time frame: From enrollment to first objective occurrence of tumor progression or death due to any cause, whichever occurs first, assessed up to 2 years
Median PFS
Time frame: Up to 24 months
Median liver-PFS
Time frame: Up to 24 months
Liver-PFS
Time frame: From enrollment to the first occurrence of radiographic progression within the liver or death due to any cause, assessed up to 1 year
Liver-PFS
Time frame: From enrollment to the first occurrence of radiographic progression within the liver or death due to any cause, assessed up to 2 years
Change in circulating tumor deoxyribonucleic acid (ctDNA)
Time frame: At baseline (weeks 0, 2, 4, and 6) and post operatively (weeks 2, 4, 6, 8, 10, 12, 14 and 16)
ctDNA clearance
Time frame: Up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pashtoon M Kasi principal investigator
City of Hope Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Biopsy Procedure, Biospecimen Collection and Computed Tomography in people with Metastatic Colorectal Carcinoma and Metastatic Malignant Neoplasm in the Liver, run by City of Hope Medical Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.