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Study of Tucatinib, Trastuzumab, and mFOLFOX6 for Patients with HER2+ Metastatic Colorectal Cancer

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This clinical trial is focused on studying a type of cancer called HER2-positive metastatic colorectal cancer. This is a form of cancer that starts in the colon or rectum and has spread to other parts of the body. The study is testing a new treatment combination that includes the drug tucatinib, which is taken as a tablet, and trastuzumab, which is given through an infusion into a vein. The trial will compare this new combination with a standard treatment called mFOLFOX6, which is a mix of chemotherapy drugs. Some participants may also receive either cetuximab or bevacizumab, which are additional drugs given through infusion.

The purpose of the study is to see how well the new treatment works in stopping the cancer from getting worse. Participants will be randomly assigned to receive either the new treatment combination or the standard treatment. The study will last for a period of time, during which participants will receive their assigned treatment and have regular check-ups to monitor their health and the progress of the cancer. The study aims to find out if the new treatment can help patients live longer without their cancer getting worse.

Throughout the study, participants will be closely monitored by healthcare professionals. They will have regular visits to the clinic for treatment and assessments, which may include blood tests and imaging scans to check the status of the cancer. The study will also look at the side effects of the treatments to ensure they are safe for patients. The information gathered from this study will help doctors understand if the new treatment combination is a better option for patients with HER2-positive metastatic colorectal cancer.

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

    Joining the study

    Upon joining the study, the patient will be randomly assigned to one of the treatment groups. This process ensures that each participant has an equal chance of receiving any of the treatment options being tested.

  2. Step 2

    Treatment administration

    The patient will receive a combination of medications depending on the assigned group. The medications include tucatinib, trastuzumab, bevacizumab, and cetuximab.

    Tucatinib is administered orally in the form of film-coated tablets, available in 50 mg and 150 mg doses. The specific dosage and frequency will be determined by the study protocol.

    Trastuzumab, bevacizumab, and cetuximab are administered intravenously as solutions for infusion. The frequency and duration of these infusions will be specified in the study protocol.

  3. Step 3

    Monitoring and assessments

    Throughout the study, the patient's health and response to treatment will be closely monitored. This includes regular assessments to evaluate the progression of the disease and any side effects experienced.

    The primary goal is to compare progression-free survival, which is the time during and after treatment that the patient lives with the disease without it getting worse.

  4. Step 4

    Completion of the study

    The study is estimated to conclude by October 31, 2028. Upon completion, the data collected will be analyzed to determine the effectiveness and safety of the treatment options.

Who can join the trial?

9 criteria

  • Have a type of cancer called **adenocarcinoma** of the colon or rectum that is advanced and cannot be removed by surgery or has spread to other parts of the body.
  • Be willing and able to provide a sample of the most recent tumor tissue for analysis. If old tissue is not available, a new biopsy (a small sample of tissue) from an accessible tumor is needed within 35 days before starting the study treatment. The biopsy must provide enough tissue for analysis and can be done using different methods like resection, excision, punch (for skin lesions only), or core needle biopsies.
  • Have a type of cancer that is **HER2+**, which means the cancer cells have more HER2 protein than normal. This is determined by specific tests done in a central laboratory.
  • Have a type of cancer that is **RAS WT**, meaning the cancer does not have certain mutations in the RAS gene. This can be tested locally or centrally, and the test should be done within one year of the biopsy date.
  • Have disease that can be measured by scans or other imaging tests, with at least one area that has not been treated with radiation before, or if it has been treated, there must be signs that the disease has progressed since the radiation.
  • Have an **ECOG Performance Status** of 0 or 1, which means the patient is fully active or has some symptoms but can still carry out light work.
  • For the **CNS (Central Nervous System)** criteria: either have no evidence of cancer spread to the brain or have previously treated brain metastases that are not causing symptoms.
  • Both male and female patients can participate.
  • Patients from vulnerable populations are included.

Who cannot join the trial?

5 criteria

  • Patients with a type of cancer that cannot be removed by surgery or has spread to other parts of the body, specifically **HER2+ colorectal cancer**, cannot participate. **HER2+** means the cancer has a protein that promotes its growth.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who belong to certain clinical trial groups that are not included in this study cannot participate.
  • Both male and female patients are considered for the study, but those who do not meet other criteria cannot participate.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
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Investigated drugs

  • Tucatinib

    is a medication used in this trial to treat HER2-positive metastatic colorectal cancer. It works by targeting and inhibiting the activity of the HER2 protein, which can promote the growth of cancer cells. By blocking this protein, tucatinib helps to slow down or stop the growth of cancer.

  • Trastuzumab

    is another medication used in combination with tucatinib. It is a type of targeted therapy known as a monoclonal antibody. Trastuzumab attaches to the HER2 protein on cancer cells, helping the immune system to recognize and destroy these cells.

  • mFOLFOX6

    is a chemotherapy regimen that includes a combination of drugs used to treat colorectal cancer. It typically consists of folinic acid, fluorouracil, and oxaliplatin. This combination works by interfering with the DNA of cancer cells, preventing them from dividing and growing.

  • Cetuximab

    is a monoclonal antibody used in some patients in this trial. It targets the epidermal growth factor receptor (EGFR) on cancer cells, blocking signals that tell the cancer cells to grow and divide. This helps to slow down the progression of the cancer.

  • Bevacizumab

    is another monoclonal antibody that may be used in this trial. It works by inhibiting the growth of blood vessels that supply nutrients to tumors, effectively starving the cancer cells and slowing their growth.

What is already known about the treatment

  • Tucatinib

    Tucatinib is administered orally and is currently being studied in clinical trials for its effectiveness in treating HER2-positive metastatic colorectal cancer. It is not yet widely established in medical practice but shows promise in ongoing research. The main therapeutic indication is for patients with unresectable or metastatic HER2-positive colorectal cancer. Tucatinib works by inhibiting the HER2 protein, which is involved in the growth and spread of cancer cells. It is classified as a tyrosine kinase inhibitor, targeting specific enzymes within cancer cells to prevent their proliferation.

  • Trastuzumab

    Trastuzumab is administered intravenously and is a well-established medication in the treatment of HER2-positive cancers, including breast and colorectal cancer. It is widely recognized in medical literature and practice. The primary therapeutic indication is for HER2-positive metastatic colorectal cancer. Trastuzumab works by binding to the HER2 protein on cancer cells, blocking them from receiving growth signals and marking them for destruction by the immune system. It is classified as a monoclonal antibody, specifically targeting the HER2 receptor.

  • Cetuximab

    Cetuximab is administered intravenously and is used in the treatment of certain types of cancer, including colorectal cancer. It is well-documented in medical literature and is an established treatment option. The main therapeutic indication is for metastatic colorectal cancer. Cetuximab works by targeting the epidermal growth factor receptor (EGFR) on cancer cells, inhibiting their growth and survival. It is classified as a monoclonal antibody, specifically targeting EGFR.

  • Bevacizumab

    Bevacizumab is administered intravenously and is a well-known medication used in the treatment of various cancers, including colorectal cancer. It is widely recognized in medical literature and practice. The primary therapeutic indication is for metastatic colorectal cancer. Bevacizumab works by inhibiting vascular endothelial growth factor (VEGF), which is responsible for the formation of new blood vessels that tumors need to grow. It is classified as an angiogenesis inhibitor, targeting the blood supply to tumors.

Investigated diseases

Colorectal Cancer – Colorectal cancer is a type of cancer that begins in the colon or rectum, parts of the large intestine. It often starts as small, benign clumps of cells called polyps, which can develop into cancer over time. As the disease progresses, it can invade nearby tissues and spread to other parts of the body, a process known as metastasis. In cases where the cancer is HER2-positive, it means that the cancer cells have more HER2 receptors than normal, which can promote the growth of cancer. When the cancer is unresectable, it cannot be removed completely through surgery. Metastatic colorectal cancer indicates that the cancer has spread beyond the colon or rectum to other organs.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514180-25-00Protocol codeSGNTUC-029Estimated enrolment400 patientsSponsorSeagen Inc.

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