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Study on the Effects of Trastuzumab Deruxtecan in Patients with Advanced or Metastatic 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 the effects of a treatment called Trastuzumab Deruxtecan, also known by its code name DS-8201a, on patients with advanced or metastatic cancer. Metastatic cancer is a type of cancer that has spread from its original site to other parts of the body. The study includes patients who are receiving this treatment as part of a clinical trial, expanded access, compassionate use, or standard treatment, regardless of the specific type of cancer they have.

The purpose of the study is to identify the best level of a specific molecule called ERBB2 mRNA that can predict how well patients will respond to Trastuzumab Deruxtecan in breast cancer. The study will involve collecting tumor samples from patients to analyze these levels and see how they relate to the overall response to the treatment. The study will also look at how these levels are associated with how long patients live without the cancer getting worse and their overall survival.

Throughout the study, researchers will also explore other factors, such as different types of breast cancer and immune-related genes, to see how they affect the response to Trastuzumab Deruxtecan. The study aims to develop a new way to predict who will benefit from this treatment and to understand any changes in the cancer that might lead to resistance to the treatment. The study is expected to continue until September 2027.

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

    Eligibility is determined for individuals diagnosed with advanced or metastatic cancer who are starting, receiving, or have received treatment with trastuzumab deruxtecan.

    Written informed consent is required from the participant or their legally acceptable representative.

  2. Step 2

    Submission of tumor samples

    A formalin-fixed, paraffin-embedded tumor tissue block from the most recently collected tumor tissue is submitted for central molecular analysis.

    If a newer specimen is unavailable, a tissue block or a new biopsy may be required. Acceptable samples include core needle biopsies or excisional biopsies.

  3. Step 3

    Treatment administration

    The treatment involves the administration of trastuzumab deruxtecan (Enhertu 100 mg) as a solution for infusion.

    The medication is given through intravenous use, following the specific dosage and frequency as prescribed by the healthcare provider.

  4. Step 4

    Monitoring and assessments

    Regular monitoring of health status and response to treatment is conducted.

    Blood samples may be required for additional assessments.

  5. Step 5

    End of study participation

    The study aims to identify the optimal ERBB2 mRNA cut-point predictive of response to trastuzumab deruxtecan.

    The study is estimated to conclude by September 30, 2027.

Who can join the trial?

6 criteria

  • Participants must be women or men who are 18 years old or older.
  • Participants should be starting, currently receiving, or have received treatment with Trastuzumab Deruxtecan for advanced or metastatic cancer. This is a specific type of cancer treatment.
  • The participant, or their legally acceptable representative, must provide written informed consent to join the study. This means they agree to participate after understanding the study details.
  • Participants need to provide a tumor tissue sample for analysis. This sample should be from the most recent tumor tissue collected and must be of good quality. If a newer sample is not available, an older one may be used, or the participant may agree to a new biopsy, which is a procedure to take a small piece of tissue for testing.
  • Acceptable tissue samples include core needle biopsies or other types of biopsies from different areas like skin or bone. However, samples from fine needle aspiration or certain fluid samples are not acceptable.
  • Participants who join the study before starting the experimental treatment must be able and willing to provide a blood sample.

Who cannot join the trial?

4 criteria

  • Patients who have not been diagnosed with advanced or metastatic cancer.
  • Patients who have not been treated with Trastuzumab Deruxtecan, which is a specific cancer treatment, in any form such as a clinical trial, expanded access, compassionate use, or standard treatment.
  • Patients who are male, as the study is only for female participants.
  • Patients who are part of a vulnerable population, which means groups that might need special protection or care.
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Investigated drugs

Trastuzumab Deruxtecan (T-DXd; DS-8201a) is a medication used in this clinical trial. It is designed to treat certain types of breast cancer by targeting and attaching to a specific protein called HER2 found on the surface of some cancer cells. Once attached, it delivers a chemotherapy drug directly into the cancer cell, which helps to kill the cancer cells while minimizing damage to normal cells. This trial aims to find the best way to predict how well this medication will work for patients with breast cancer.

What is already known about the treatment

Trastuzumab Deruxtecan – This medication is administered intravenously, meaning it is given through a vein. It is currently being studied in clinical trials for its effectiveness in treating advanced or metastatic cancer, particularly in patients with breast cancer. The main therapeutic use of Trastuzumab Deruxtecan is to target and treat cancers that express the HER2 protein. At the molecular level, it works by binding to the HER2 protein on cancer cells, delivering a chemotherapy agent directly to the cells, which helps to kill them. It is classified as an antibody-drug conjugate, combining targeted therapy with chemotherapy.

Investigated diseases

Breast Cancer – Breast cancer is a disease where cells in the breast grow uncontrollably, forming a tumor that can often be felt as a lump. It typically begins in the ducts or lobules of the breast and can spread to other parts of the body if not managed. The progression of breast cancer can vary, with some types growing slowly and others more rapidly. It is often categorized by hormone receptor status and HER2 protein levels, which can influence growth and treatment response. Early stages may not cause noticeable symptoms, but as it advances, symptoms like changes in breast shape, lumps, or skin changes may occur.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-508830-33-00Protocol codeSOLTI-1804Estimated enrolment180 patientsSponsorSolti Group

sourced from the EU Clinical Trials Register and site verification

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