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Study of zanidatamab in adult patients with HER2-positive solid tumors (endometrial, colorectal, head & neck, sarcoma) or HER2-mutant non-small cell lung cancer

Verified siteInvestigationalNo 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 focuses on treating patients with various types of solid tumors that have specific characteristics related to the HER2 gene. The study includes several types of cancer: endometrial cancer, colorectal cancer, head and neck cancer, non-small cell lung cancer, and sarcoma. These cancers must either show high levels of HER2 protein or have mutations in the HER2 gene.

The study uses a medication called zanidatamab (also known as JZP598), which is given through an intravenous infusion. This medicine is a powder that is first made into a concentrated solution before being given to patients. The maximum daily dose that can be given is 2400 milligrams, and treatment may continue for up to three years.

The main goal of this research is to determine how well zanidatamab works in treating these different types of cancer. The study will look at whether tumors respond to the treatment by shrinking or disappearing. Doctors will monitor patients regularly using scans to check how the tumors are responding to the treatment and to watch for any side effects that may occur.

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

    Initial treatment preparation

    Your treatment will involve zanidatamab, which is given through an intravenous infusion (directly into your vein)

    Before starting treatment, you will need to undergo tests to confirm your heart function shows a left ventricular ejection fraction of 50% or higher

    A blood test will check your liver function, kidney function, blood cell counts, and blood clotting ability

  2. Step 2

    Treatment administration

    You will receive zanidatamab in the form of an infusion

    The medication comes as a powder that is mixed into a solution before being given through your vein

    Regular monitoring of your vital signs will occur during the infusion

  3. Step 3

    Ongoing assessments

    Your response to treatment will be evaluated regularly using imaging scans

    The first assessment of treatment response will occur after the initial treatment period

    Follow-up scans will be performed at least 4 weeks after the first response is observed

    Regular blood tests will monitor your liver function, kidney function, and blood cell counts

  4. Step 4

    Safety monitoring

    Any side effects will be monitored and recorded throughout your treatment

    Your heart function will be checked periodically

    You should report any new symptoms or concerns to your healthcare team

  5. Step 5

    Treatment continuation

    Treatment will continue as long as you are experiencing benefits and no serious side effects occur

    Regular assessments will determine if the treatment should continue

    The study is planned to continue until March 2030

Who can join the trial?

16 criteria

  • Must be at least 18 years old
  • Must have confirmed diagnosis of one of these cancers: - Endometrial cancer - Colorectal cancer - Head and neck cancer - Non-small cell lung cancer (NSCLC) - Sarcoma (a type of cancer that starts in bones or soft tissues)
  • Must have cancer that is either advanced, has spread, or cannot be surgically removed
  • Must have previously received at least one other treatment that is no longer working
  • Must have adequate liver function based on specific blood test results
  • Must have good heart function with heart pumping capacity of at least 50%
  • Must have adequate kidney function
  • Must have adequate bone marrow function, shown by specific blood cell counts
  • Must have measurable disease that can be evaluated by scans
  • Must have a life expectancy of more than 3 months
  • Must have a performance status of 2 or better (able to perform most daily activities)
  • Must provide a suitable tumor tissue sample for testing or agree to a biopsy
  • Must agree to use effective birth control during the study (if applicable)
  • Women who can become pregnant must have a negative pregnancy test within 3 days before starting treatment
  • Must be willing and able to follow all study procedures and attend scheduled visits
  • Must sign an informed consent form before starting any study procedures

Who cannot join the trial?

13 criteria

  • Prior treatment with HER2-directed therapy (therapy targeting a specific protein called HER2) within 4 weeks before starting the study
  • Active brain metastases (cancer that has spread to the brain) that are untreated or unstable
  • History of other cancer within the past 2 years, except for successfully treated non-melanoma skin cancer or cervical cancer in situ
  • Severe heart conditions, including:
    • Heart failure with symptoms
    • Unstable heart rhythm problems
    • Heart attack within the past 6 months
    • Active or uncontrolled infections requiring treatment
    • Known infection with HIV, active hepatitis B, or active hepatitis C
    • Any serious medical condition that could interfere with study participation
    • Pregnant or breastfeeding women
    • Unable to swallow oral medications
    • Known allergies to the study medication or its components
    • Participation in another clinical trial within 4 weeks before starting this study
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Investigated drugs

Zanidatamab is a medication designed to target HER2, a protein that can be overexpressed in certain types of cancer. It is an antibody-based therapy that works by attaching to HER2 proteins on cancer cells, helping to stop or slow down cancer growth. This medication is being studied in patients who have various types of solid tumors that either have too much HER2 protein or mutations in the HER2 gene.

What is already known about the treatment

Zanidatamab - A novel bispecific antibody therapy administered through intravenous infusion, specifically designed to target HER2-positive cancers. This investigational drug works by binding to two different sites on the HER2 receptor simultaneously, creating a more effective blocking mechanism that inhibits cancer cell growth and survival signaling pathways. Zanidatamab belongs to the class of targeted immunotherapies and is currently being studied in clinical trials for various HER2-positive solid tumors, including endometrial cancer, colorectal cancer, head and neck cancer, sarcoma, and HER2-mutant non-small cell lung cancer. The medication represents a promising approach in precision medicine, particularly for patients whose cancers show high HER2 expression (IHC3+) or specific HER2 mutations.

Investigated diseases

  • Endometrial cancer

    A cancer that begins in the lining of the uterus (endometrium). It typically develops when cells in the endometrium start growing abnormally and form a tumor. The disease most commonly occurs in women after menopause.

  • Colorectal cancer

    A cancer that starts in the large intestine (colon) or rectum. It typically begins as small, benign clumps of cells called polyps that over time can become cancerous. The disease develops gradually and affects the digestive system.

  • Head and neck cancer

    A group of cancers that starts in the tissues and organs of the head and neck area. These cancers can begin in the mouth, throat, voice box, nasal cavity, or sinuses. The disease affects the upper parts of the digestive and respiratory tracts.

  • Sarcoma

    A rare type of cancer that develops in the body's connective tissues. It can occur in bones, muscles, tendons, cartilage, nerves, fat, and blood vessels. The disease can develop anywhere in the body.

  • Non-small cell lung cancer

    A type of lung cancer that forms in the tissues of the lung. It is the most common type of lung cancer, developing in the cells that line the air passages. The disease typically grows and spreads more slowly than small cell lung cancer.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-522169-31-00Protocol codeUC-GMP-2505Estimated enrolment105 patientsSponsorUnicancer

sourced from the EU Clinical Trials Register and site verification

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