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A study to evaluate the safety and effectiveness of darizmetinib hydrochloride in patients who have had liver surgery due to colon cancer metastases

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study aims to evaluate the safety and effectiveness of the drug HRX215, which contains darizmetinib hydrochloride, in individuals who have undergone liver surgery. The research focuses on patients who required a hepatectomy, which is the surgical removal of part or all of the liver, because of colon carcinoma metastases. This condition occurs when cancer that started in the colon spreads to the liver.

Participants in the study will be assigned to receive either the active medication HRX215 taken as an oral capsule or a placebo. The study is designed so that neither the participants nor the researchers know which substance is being administered. During the course of the study, the way the body absorbs, processes, and removes the medication will be monitored and compared to data from healthy individuals.

The research also involves looking at how the liver recovers after surgery. This includes monitoring changes in liver volume, which is the amount of space the liver occupies in the body, using computed tomography, a type of medical imaging that uses X-rays to create detailed pictures of the inside of the body. General health indicators, such as vital signs and blood tests, will also be tracked to ensure patient safety.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Study medication administration

    You will receive either the test medication, known as HRX215 (containing darizmetinib hydrochloride), or a placebo, which is an inactive capsule that looks like the medication.

    The HRX215 is taken by mouth in the form of a capsule.

  2. Step 2

    Safety and health monitoring

    Health status will be monitored through physical examinations and measurements of vital signs, such as blood pressure and heart rate.

    blood tests will be performed to check hematology (the study of blood cells), blood glucose (sugar levels), and other clinical laboratory parameters to ensure safety.

    Any adverse events, which are unintended medical occurrences or side effects, will be recorded and evaluated for severity.

  3. Step 3

    Liver volume assessment

    liver volume will be measured using CT scans (imaging tests that use X-rays to create detailed pictures of the body) on post-operative day 1 (the first day after surgery) and post-operative day 7 (the seventh day after surgery).

    The change in liver volume from the first day to the seventh day after surgery will be evaluated.

  4. Step 4

    Medication movement tracking

    The way the body absorbs, modifies, breaks down, and removes the HRX215 medication will be studied by measuring levels in the plasma (the liquid part of the blood).

Who can join the trial?

12 criteria

  • You must be between 18 and 75 years old.
  • You must provide written signed informed consent, which means you agree to take part in the study after reading and understanding all the details.
  • You must have liver metastases, which are cancer cells that have spread to the liver, originating from colon carcinoma (a type of cancer that starts in the colon).
  • You must be scheduled for an R0-intended hepatectomy, which is a surgery to remove part of the liver with the goal of removing all visible cancer cells.
  • For the first part of the study, your liver must be stable within 1 to 3 days after a minor liver resection (a small surgical removal of liver tissue), or a liver biopsy (a procedure where a small piece of liver tissue is removed to be examined under a microscope) must show that the non-cancerous part of your liver is normal.
  • Depending on the part of the study, your remnant liver volume (the amount of healthy liver left after surgery) or your estimated future liver remnant (the predicted amount of liver that will remain after surgery) must meet specific percentages calculated from MRI or CT scans (specialized medical imaging tests).
  • Your doctor must determine that you are at a low risk for postoperative liver failure, which is a condition where the liver cannot function properly after surgery.
  • You must have a good general health status, defined as WHO 0 or 1 or ECOG 0 or 1, which are scales used by doctors to measure how well a patient can perform daily activities.
  • Your expected life expectancy must be more than 6 months.
  • Your blood tests must show certain levels are within a healthy range, including platelets (cells that help blood clot), neutrophils (a type of white blood cell that fights infection), hemoglobin (a protein in red blood cells that carries oxygen), creatinine (a waste product filtered by the kidneys), bilirubin (a yellow substance produced by the breakdown of red blood cells), albumin (a protein made by the liver), AST and ALT (enzymes that show how well the liver is working), and INR (a test that measures how long it takes for your blood to clot).
  • You must agree to use highly effective contraception (methods to prevent pregnancy) from the time you sign the consent form until at least 36 days after your last dose of the study drug.
  • You must have enough non-tumor liver tissue available for a baseline histology assessment, which is a microscopic examination of healthy liver cells to ensure safety.

Who cannot join the trial?

26 criteria

  • Having liver cirrhosis, which is permanent scarring and damage to the liver tissue.
  • Having a known allergy or medical reason not to use iodine contrast agents, which are special dyes used during medical imaging tests like CT scans.
  • Taking anticoagulants, which are medicines used to prevent blood clots, if they cannot be safely stopped for at least 48 hours before the study treatment. This includes DOACs, heparin, and antivitamin K.
  • Receiving chemotherapy, which is a type of cancer treatment, within the 30 days before surgery.
  • Having received more than 12 cycles or more than 6 months of preoperative chemotherapy before surgery.
  • Expecting to start adjuvant chemotherapy, which is additional cancer treatment given after the main treatment to lower the risk of cancer returning, before the 28-day study period is finished. This includes treatment via an intrahepatic arterial pump, a device used to deliver medicine directly to the liver.
  • Testing positive for an active hepatitis B virus (HBV), hepatitis C virus (HCV), or autoimmune hepatitis, which are different types of liver inflammation or infections.
  • Having an incomplete liver metastasis resection, meaning that not all of the cancer spread to the liver could be removed during surgery.
  • Having undergone an embolization procedure of the portal vein or hepatic vein, which is a procedure to block blood flow to certain areas, or a surgical hepatic augmentation procedure like ALPPS, which is a complex surgery to prepare the liver for larger removals.
  • Having high-grade dysplastic lesions, which are abnormal cell growths that could become cancer, that cannot be fully removed during surgery.
  • Having a history of malignancy, which is a medical term for cancer, within the last five years, unless it was a specific type of skin cancer or cervical cancer that was completely removed.
  • Being under legal incapacity, such as being in custody or under guardianship.
  • Having clinical ascites before surgery, which is the buildup of fluid in the abdomen.
  • Being deprived of liberty due to a legal or administrative decision.
  • Being unable to sign the informed consent document, which is the legal paper where you agree to join the study, or being unable to follow the medical check-ups due to location, social, or psychological reasons.
  • Having medical reasons that prevent you from having MRI or CT exams, which are types of medical imaging used to see inside the body.
  • Being unable to stop taking a concomitant medication, which is any medicine you are currently taking, that is broken down by the body using a specific enzyme called CYP2D6.
  • Having any other type of hepatobiliary cancer, which is cancer affecting the liver or the bile ducts.
  • Having a body mass index (BMI) greater than 35 kg/m2, which is a measure of body fat based on height and weight.
  • Having an American Society of Anesthesiologists (ASA) Score of 4 or higher, which is a scale doctors use to rate a patient's overall health before surgery.
  • Having peritoneal disease, which is a condition affecting the lining of the abdomen, or findings that show the cancer cannot be surgically removed.
  • Having a Completeness of Cytoreduction (CC) Score greater than 0, which means that some cancer cells were left behind after surgery.
  • Having peritoneal carcinomatosis, which is the spread of cancer cells throughout the lining of the abdomen.
  • Participating in another therapeutic trial with an experimental drug within 28 days before or during the 6-month follow-up period after surgery.
  • Having a serious non-stabilized disease, an active uncontrolled infection, or another serious health issue that would make it unsafe to receive the treatment.
  • Being pregnant (confirmed by a βHCG positive test) or breastfeeding.
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Investigated drugs

HRX215 is an experimental oral capsule being studied to see how safe it is and how well it works for people who have undergone surgery to remove parts of their liver due to cancer that spread from the colon.

What is already known about the treatment

  • Placebo

    This is an inactive substance delivered in the form of a white opaque capsule that is swallowed by mouth. It is used in clinical studies as a control to compare against the active drug to ensure results are accurate. Since it contains no medicine, it has no specific therapeutic use or biological effect on the body.

  • Darizmetinib hydrochloride

    This medication is taken orally in the form of a capsule to treat certain types of cancer, such as colon cancer that has spread. It is currently being studied in clinical trials to determine its safety and effectiveness in patients recovering from liver surgery. As a targeted therapy, it works by blocking specific proteins in cells that help cancer grow and spread, thereby stopping the progression of the disease.

Investigated diseases

Colorectal cancer liver metastases - This condition occurs when cancer cells from the colon or rectum spread through the bloodstream or lymphatic system to the liver. The process begins with a primary tumor in the digestive tract. Once the cancer cells reach the liver, they begin to grow into new tumor masses within the liver tissue. As these growths increase in size, they can occupy more space within the organ. This progression involves the continuous multiplication of abnormal cells in a new location.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2025-523630-59-00Protocol codeHRX215-CR03-LR01Estimated enrolment79 patients

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