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Study of Tucatinib and Trastuzumab for Patients with Advanced Solid Tumors with HER2 Changes

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 the effects of a combination of two medications, tucatinib and trastuzumab, on certain types of cancer. The cancers being studied are solid tumors that have specific changes in a protein called HER2. These tumors are either locally advanced, meaning they have grown significantly but have not spread to distant parts of the body, or metastatic, meaning they have spread to other areas. The purpose of the study is to evaluate how well these medications work together in treating these types of tumors.

Participants in the study will receive the medications tucatinib and trastuzumab. Tucatinib is taken orally in the form of tablets, while trastuzumab is given through an intravenous infusion, which means it is delivered directly into the bloodstream through a vein. The study will last for a period of up to 58 weeks, during which the participants will be monitored regularly to assess the effects of the treatment on their cancer. The study will also include a group of participants who will receive a placebo, which is a substance with no active medication, to compare the results.

The trial aims to understand the antitumor activity of the combination treatment in patients who have already received other treatments for their cancer. The study will look at various outcomes, such as the rate of tumor shrinkage, the duration of response to the treatment, and overall survival rates. Additionally, the study will monitor the safety of the treatment by recording any side effects or adverse events experienced by the participants. This research is important for developing new treatment options for patients with HER2-altered solid tumors.

The research process

The trial runs in 5 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 informed about the trial's purpose, which is to evaluate the effectiveness of tucatinib in combination with trastuzumab for treating certain types of tumors.

    The patient will receive detailed information about the trial procedures, potential risks, and benefits.

  2. Step 2

    Initial assessment

    The patient will undergo an initial assessment to confirm eligibility, which includes verifying the presence of HER2 alterations in the tumor.

    Tests may include imaging and laboratory assessments to establish baseline health status.

  3. Step 3

    Treatment phase

    The patient will begin treatment with trastuzumab administered as an intravenous infusion. The specific dosage and frequency will be determined by the study protocol.

    In addition, the patient will take tucatinib orally. The dosage will be either 150 mg or 50 mg film-coated tablets, as prescribed by the study protocol.

    The patient may also receive fulvestrant as an intramuscular injection, depending on the specific requirements of the study.

  4. Step 4

    Monitoring and follow-up

    Throughout the treatment phase, the patient's response to the medication will be closely monitored through regular medical assessments.

    The patient will undergo periodic imaging and laboratory tests to evaluate the effectiveness of the treatment and to monitor for any side effects.

  5. Step 5

    Completion of treatment

    Upon completion of the treatment phase, the patient will have a final assessment to determine the overall response to the therapy.

    The patient will be informed about the results and any further steps that may be necessary based on the outcomes of the trial.

Who can join the trial?

8 criteria

  • The patient must have a confirmed diagnosis of a **locally-advanced** (cancer that has spread to nearby areas but not distant parts of the body) or **metastatic solid tumor** (cancer that has spread to other parts of the body), including primary brain tumors.
  • The patient must have received prior treatment and shown progression or intolerance to the most recent treatment. This means the cancer continued to grow or the patient could not tolerate the treatment.
  • The patient's cancer must show **HER2 alterations**. HER2 is a protein that can affect the growth of cancer cells. This can be determined by specific tests on tumor tissue or blood.
  • The patient must have **measurable disease** according to specific criteria used by doctors to assess cancer size and spread.
  • The patient must have adequate **hepatic function**, meaning the liver is working well enough. This is checked by specific blood tests measuring liver enzymes and bilirubin levels.
  • The patient must have a **left ventricular ejection fraction (LVEF)** of at least 50%. LVEF is a measure of how well the heart pumps blood, assessed by an echocardiogram or a scan.
  • The trial is open to both male and female patients.
  • The trial includes patients from vulnerable populations, meaning those who might need special considerations.

Who cannot join the trial?

7 criteria

  • Patients who have not been previously treated for their condition.
  • Patients with tumors that can be surgically removed.
  • Patients without HER2 alterations. HER2 is a protein that can affect the growth of cancer cells.
  • Patients with tumors that are not locally advanced or metastatic. Locally advanced means the cancer has spread to nearby areas, and metastatic means it has spread to other parts of the body.
  • Patients who are not within the specified age range for the study.
  • Patients who are not part of the specified clinical trial groups.
  • Patients who are not considered part of the vulnerable population selected for the study.
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Investigated drugs

  • Tucatinib

    is a medication used in this trial to target tumors that have specific changes in the HER2 protein. It works by blocking the signals that help cancer cells grow, which may slow down or stop the growth of the tumor.

  • Trastuzumab

    is another medication used in combination with tucatinib in this trial. It is an antibody that attaches to the HER2 protein on cancer cells, helping the immune system to recognize and destroy these cells. This combination aims to enhance the treatment's effectiveness against tumors with HER2 alterations.

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 certain types of cancer. It is primarily used for patients with solid tumors that have specific HER2 alterations, which are often difficult to treat with standard therapies. Tucatinib works by specifically inhibiting the HER2 protein, which is involved in the growth and spread of cancer cells. It belongs to a class of drugs known as tyrosine kinase inhibitors, which block the action of enzymes involved in cancer cell signaling.

  • Trastuzumab

    Trastuzumab is given through an intravenous infusion and is a well-established medication in the treatment of HER2-positive cancers, particularly breast cancer. It is used in combination with other therapies to target tumors that overexpress the HER2 protein. Trastuzumab works by binding to the HER2 receptors on the surface of cancer cells, preventing them from receiving growth signals and marking them for destruction by the immune system. It is classified as a monoclonal antibody, which is a type of targeted therapy designed to interfere with specific proteins involved in cancer cell growth.

Investigated diseases

HER2-Positive Solid Tumors – These are a group of cancers characterized by the overexpression or amplification of the human epidermal growth factor receptor 2 (HER2) protein. This alteration can lead to aggressive tumor growth and is commonly found in breast cancer, but can also occur in other types of solid tumors. The disease can be locally advanced, meaning it has spread to nearby tissues, or metastatic, indicating it has spread to distant parts of the body. Patients with this condition have typically undergone previous treatments, but the tumors remain unresectable, meaning they cannot be surgically removed. The progression of the disease involves the continued growth and spread of cancer cells, often requiring ongoing management to control symptoms and tumor growth.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511481-37-00Protocol codeSGNTUC-019Estimated enrolment164 patientsSponsorSeagen Inc.

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