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Study of Trastuzumab Deruxtecan Treatment for Patients with Advanced Solid Tumors Having HER2 Mutations

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 study focuses on treating patients with solid tumors that have specific HER2 mutations. These tumors are either unable to be surgically removed (unresectable) or have spread to other parts of the body (metastatic). The study will test a medication called trastuzumab deruxtecan (also known as T-DXd or DS-8201a), which is given through an intravenous infusion directly into the bloodstream.

The purpose of this research is to determine how well trastuzumab deruxtecan works in treating tumors that have specific HER2 mutations, regardless of where in the body the tumor started. HER2 mutations are changes in a gene that can affect how cancer cells grow and spread. This medication is designed to specifically target cancer cells that have these HER2 mutations.

During the study, participants will receive trastuzumab deruxtecan through intravenous infusions. The treatment will continue as long as it appears to be helping and the side effects are manageable. Throughout the study, doctors will monitor the participants' health and how their tumors respond to the treatment. This includes regular medical check-ups and various tests to evaluate the safety and effectiveness of the medication.

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 qualification

    Your medical history and current health status will be reviewed to confirm eligibility for the study.

    You must be at least 18 years old and have an unresectable or metastatic solid tumor with specific HER2 mutations.

    Your heart function will be checked to confirm that your heart ejection fraction is 50% or higher.

    Your physical performance status will be evaluated to ensure you meet the required activity level.

  2. Step 2

    Tumor sample collection

    A sample of your tumor tissue will be collected for central laboratory testing.

    This tissue sample will be used to confirm the presence of specific HER2 mutations.

  3. Step 3

    Treatment administration

    You will receive trastuzumab deruxtecan (T-DXd) through an intravenous infusion.

    The medication will be given as a solution for infusion.

    Regular visits will be scheduled for treatment administration and monitoring.

  4. Step 4

    Monitoring and evaluation

    Your response to treatment will be assessed through regular imaging scans.

    Blood samples will be collected to measure drug levels in your body.

    Your overall health and any side effects will be monitored throughout the study.

    The study team will check for the presence of antibodies against the study medication.

  5. Step 5

    Study duration

    The study is scheduled to continue until July 2026.

    Your participation duration will depend on how your body responds to the treatment.

    Regular assessments will determine if you are benefiting from the treatment.

Who can join the trial?

9 criteria

  • Must be at least 18 years old
  • Have tumors that cannot be surgically removed (unresectable) and/or cancer that has spread to other parts of the body (metastatic solid tumors)
  • Have specific changes (mutations) in a gene called HER2, which must be confirmed by genetic testing (NGS) of tumor tissue
  • Have experienced disease progression after previous treatment or have no other suitable treatment options available
  • Can have received previous treatments targeting HER2
  • Must be able to provide a preserved tumor tissue sample (FFPE tumor sample) for additional testing
  • Must have good heart function with a pumping ability (LVEF) of 50% or higher
  • Must have good physical performance status (ECOG 0-1), meaning able to perform daily activities with minimal or no restrictions
  • Both men and women can participate

Who cannot join the trial?

12 criteria

  • Patients who have uncontrolled brain metastases (cancer that has spread to the brain and is not responding to treatment)
  • Patients with severe heart conditions including heart failure, irregular heartbeat, or recent heart attack (within 6 months)
  • Patients with active infections that require systemic treatment (medications that affect the whole body)
  • Pregnant or breastfeeding women
  • Patients who have received other cancer treatments within 14 days before starting this study
  • Patients with severe liver problems (poor liver function)
  • Patients with severe kidney problems (poor kidney function)
  • Patients who have participated in another clinical trial within 28 days before starting this study
  • Patients who have had major surgery within 28 days before starting this study
  • Patients with known allergies to the study medication or its components
  • Patients who cannot perform daily activities independently or require constant care
  • Patients with other serious medical conditions that could interfere with study participation
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Investigated drugs

Trastuzumab Deruxtecan (T-DXd) is a medication used to treat various types of cancers that have specific genetic changes in the HER2 gene. It is a targeted therapy that combines two components: one part that targets cancer cells with HER2 mutations, and another part that delivers cancer-killing medicine directly to these cells. This medication is designed to work on different types of solid tumors throughout the body that have these specific genetic changes, regardless of where the cancer started.

What is already known about the treatment

Trastuzumab Deruxtecan (T-DXd) - This is an advanced antibody-drug conjugate administered through intravenous infusion, specifically designed for treating unresectable and/or metastatic solid tumors that have HER2 activating mutations, regardless of tumor type. The medication combines a HER2-targeted antibody with a potent topoisomerase I inhibitor payload, delivering targeted cancer-fighting medication directly to tumor cells that express HER2 mutations. As a novel therapeutic agent in clinical trials, it belongs to the class of targeted cancer therapies and represents a significant advancement in precision medicine, showing promising results in treating various types of solid tumors that were previously difficult to treat effectively.

Investigated diseases

Solid Tumors with HER2 Mutations - A condition where abnormal cell growths (tumors) develop in various body tissues and contain specific mutations in the HER2 gene. These tumors can occur in different organs and body parts, with the common feature being genetic changes in the HER2 protein that affect cell growth and division. The condition is characterized by tumors that cannot be surgically removed (unresectable) and/or have spread to other parts of the body (metastatic). The disease progresses as cancer cells with these HER2 mutations continue to grow and potentially spread to other locations. These mutations can occur across various types of solid tumors, regardless of where the cancer originally started in the body.
Trial detailsLast updated 8 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516158-22-00Protocol codeD967MC00001Estimated enrolment64 patientsSponsorAstraZeneca AB

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