HRX215 for Colorectal Cancer Liver Metastasis After Portal Vein Embolization
This study is testing a drug called HRX215 for patients with colorectal cancer that has spread to the liver (liver metastasis). This is for patients who have already had a portal vein embolization (PVE), a procedure to help prepare the liver for surgery. The goal is to see if HRX215 can help increase the size of the healthy part of the liver that will remain after surgery (future liver remnant size, or FLR). This is important because a larger FLR can make surgery safer and more possible. You may be able to join if you are an adult between 18 and 90 years old with measurable liver tumors from colorectal cancer. The study plans to enroll 80 participants. The current recruitment status is unclear.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It is a Phase IIb trial and plans to enroll 80 participants.
- What's involved
- Participants will undergo a tissue biopsy, blood sample collection, and imaging tests like CT and CT-PET scans. They will also receive Darizmetinib orally and undergo Embolization Therapy (PVE).
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcome, future liver remnant size, will be measured at 28 days after the start of the study.
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NCT07612007
HRX215, A First Generation MKK4 Inhibitor Drug, for the Treatment of Patients With Colorectal Liver Metastasis After Undergoing a Portal Vein Embolization
Not Yet Recruiting
PHASE2Ages 18–90InterventionalTreatmentMayo ClinicInvestigator-initiated
~80 participants
Updated 2026-06-12 on ClinicalTrials.gov
What's tested:Biopsy ProcedureBiospecimen CollectionComputed TomographyDarizmetinibEmbolization TherapyHepatectomy
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Future liver remnant size (FLR)
Measured over At day 28 post-baseline
Conditions
Where it's being run
1 sites across 1 statesMinnesota1
Study leadership
- Scott L. Nyberg, MD, PhD · PRINCIPAL_INVESTIGATOR · Mayo Clinic in Rochester
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
REGISTRATION: Adults 18-90 years
REGISTRATION: Individuals with metachronous colorectal carcinoma liver metastases (CRCLM) after resection of the primary OR synchronous CRCLM with planned simultaneous resection of primary and metastatic disease
REGISTRATION: Measurable intrahepatic disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) and considered resectable by multidisciplinary tumor board with at least one senior hepatic surgeon
REGISTRATION: Available CT suitable for volumetric studies on FLR ≤ 21 days
REGISTRATION: Clinical indication for PVE prior to major hepatectomy as evaluated by at least one senior hepatic surgeon
REGISTRATION: Estimated life expectancy ≥ 3 months as evaluated and approximated by a senior hepatic surgeon
REGISTRATION: Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
REGISTRATION: Platelets ≥ 100,000/mm\^3 (≤ 15 days prior to registration)
REGISTRATION: Polynuclear neutrophils ≥ 1000/mm\^3 (≤ 15 days prior to registration)
REGISTRATION: Hemoglobin ≥ 9 g/dL (≤ 15 days prior to registration) (post-transfusion participants can be included)
REGISTRATION: Creatinine ≤ 1.5 x upper limit of normal (ULN) (≤ 15 days prior to registration)
REGISTRATION: Bilirubin ≤ ULN (≤ 15 days prior to registration)
REGISTRATION: Albumin ≥ 3 g/dL (≤ 15 days prior to registration)
REGISTRATION: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN (≤ 15 days prior to registration)
REGISTRATION: International normalized ratio ≤ 1.5 (≤ 15 days prior to registration)
REGISTRATION: Of note, a slight deviation from normal ranges of liver function tests, circulating cell counts, and kidney function can be assumed after systemic neoadjuvant chemotherapy prior to PVE (Field et al., 2008; Takamoto et al., 2010; Lock et al., 2017), which is accounted for in the above list. These parameters at inclusion will then serve as patient baseline
REGISTRATION: Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only. Serum or urine human chorionic gonadotropin test is suitable. Can be done with a home test and results reported by participant to the site
REGISTRATION: Provide written informed consent
REGISTRATION: Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
RANDOMIZATION: Adults 18-90 years
RANDOMIZATION: Individuals with metachronous CRCLM after resection of the primary OR synchronous CRCLM with planned simultaneous resection of primary and metastatic disease
RANDOMIZATION: Estimated life expectancy ≥ 3 months as evaluated and approximated by a senior hepatic surgeon
RANDOMIZATION: Measurable intrahepatic disease as defined by RECIST and considered resectable by multidisciplinary tumor board with at least one senior hepatic surgeon
RANDOMIZATION: Available CT suitable for volumetric studies on FLR ≤ 21 days
RANDOMIZATION: Scheduled for PVE prior to major hepatectomy
REGISTRATION: History of myocardial infarction ≤ 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
Exclusion
REGISTRATION: Cirrhosis or clinical ascites
REGISTRATION: Patients with synchronous CRCLM and scheduled staged approach (i.e., resection of metastatic hepatic disease after PVE followed by resection of the colorectal primary in a second operation)
REGISTRATION: Any liver cancer other than CRLM
REGISTRATION: Contraindications to imaging or perioperative management:
Allergy/contraindication to iodine contrast
Anticoagulation with heparin/antivitamin K (AVK) that cannot be interrupted for 48 hours
Antiplatelet therapy (e.g., clopidogrel) that cannot be interrupted for 5 days
REGISTRATION: Inability to discontinue cytochrome P450 (CYP)2D6 inhibitor concomitant medication from start of trial treatment to day 28
REGISTRATION: Inoperability due to underlying chronic diseases and co-morbidities as assessed by the hepatobiliary surgeon during screening visit
REGISTRATION: Anticipated need to start adjuvant chemotherapy prior to completion of 28 day treatment period
REGISTRATION: Positive test at screening for active hepatitis B virus (HBV)/hepatitis C virus (HCV), defined as history of seropositivity for hepatitis B virus (unless immune due to vaccination or resolved natural infection or unless passive immunization due to immunoglobulin therapy), i.e., positive test for anti-hepatitis B core antigen and negative test for anti-hepatitis B surface antibody. Ongoing, non-cured hepatitis C virus (HCV) infection. Likewise, autoimmune hepatitis will be excluded based on serological \[antinuclear antibodies (ANA), smooth muscle antibodies (SMA), and biochemical parameters AST and ALT\], patients with serological and/or biochemical findings suggestive of probable autoimmune hepatitis will be excluded
REGISTRATION: Legal incapacity (persons in custody or under guardianship)
REGISTRATION: Deprived of liberty subject (by judicial or administrative decision)
REGISTRATION: Impossibility to sign the informed consent document or to adhere to the medical follow-up of the trial for geographical, social, or psychological reasons
REGISTRATION: Any of the following because this study involves an investigational agent, the genotoxic, mutagenic and teratogenic effects of which on the developing fetus and newborn are unknown
Pregnant persons
Nursing persons
Persons of childbearing potential who are unwilling to employ adequate contraception. Participants of childbearing potential must use highly effective contraception (hormonal methods, intrauterine device (IUD)/intrauterine system (IUS), bilateral tubal occlusion, or vasectomized partner) during treatment and for a defined post-treatment period of 30 days. True abstinence is acceptable if consistent with lifestyle. Barrier methods alone are insufficient unless combined. Male participants with partners of childbearing potential must use condoms and avoid sperm donation during and after treatment
REGISTRATION: Any of the following prior therapies:
Major surgical procedures ≤ 3 weeks prior to registration
Bevacizumab as part of systemic cancer treatment ≤ 2 weeks prior to registration
REGISTRATION: Failure to recover from any adverse events related to any of the following therapies received prior to registration:
Chemotherapy
Immunotherapy
Targeted therapies
Other investigational agents
Radiation therapy
Major surgical procedures
REGISTRATION: Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
REGISTRATION: Uncontrolled intercurrent illness including, but not limited to:
Ongoing or active infection
Symptomatic congestive heart failure
Unstable angina pectoris
Cardiac arrhythmia
Dyspnea at rest due to complications of advanced malignancy or other disease that requires continuous oxygen therapy
Psychiatric illness/social situations that would limit compliance with study requirements
REGISTRATION: Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy
NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial
REGISTRATION: Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm in the neoadjuvant setting or during active treatment phase of this study (adjuvant treatment after active treatment phase is completed does not apply)
What this trial measures
- Future liver remnant size (FLR)At day 28 post-baseline
Will be defined as the percentage of the liver expected to remain after a planned hepatectomy. Will be compared between the two treatment groups \[HRX215 versus (vs) placebo\] utilizing an analysis of covariance (ANCOVA) F-test controlling for age, gender, and FLR at baseline.