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Study of Trastuzumab Deruxtecan for Patients with Metastatic or Unresectable HER2 Expressing Tumors

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 is focused on studying the effects of a medication called Trastuzumab Deruxtecan, also known by its code name DS-8201a. The study is aimed at patients with certain types of tumors that express a protein called HER2. These tumors can include cancers of the biliary tract, bladder, cervix, endometrium, ovaries, and pancreas, as well as some rare tumors. The purpose of the study is to evaluate how effective and safe this medication is for treating these specific types of cancer.

Participants in the study will receive the medication as a solution through an intravenous infusion, which means it will be administered directly into a vein. The study will observe how the tumors respond to the treatment and monitor any side effects that may occur. The trial will also look at how long the treatment remains effective and how it impacts the overall survival of the patients. The study is designed to gather information over a period of time to understand the benefits and risks associated with the medication.

By participating in this study, researchers hope to gain valuable insights into the treatment of HER2-expressing tumors and potentially improve outcomes for patients with these types of cancer. The study will help determine if Trastuzumab Deruxtecan can be a viable treatment option for those who have limited alternatives or have not responded well to previous treatments. The findings from this research could contribute to the development of new strategies for managing these challenging conditions.

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, eligibility is confirmed based on specific criteria such as having locally advanced, unresectable, or metastatic disease. The disease must be one of the selected HER2-expressing tumor types, including biliary tract, bladder, cervical, endometrial, epithelial ovarian, pancreatic cancers, or rare tumors with HER2 expression.

    Eligibility also requires progression following prior treatment or lack of satisfactory alternative treatment options. Prior HER2 targeting therapy is allowed, and HER2 expression must be confirmed by local or central assessment.

  2. Step 2

    Treatment administration

    The treatment involves the administration of trastuzumab deruxtecan (also known as DS-8201a), which is a solution for infusion given intravenously. The specific dosage and frequency of administration are determined by the study protocol and the healthcare provider overseeing the treatment.

  3. Step 3

    Monitoring and assessments

    Throughout the study, regular monitoring and assessments are conducted to evaluate the treatment's efficacy and safety. This includes measuring the objective response rate (ORR) according to RECIST version 1.1, as assessed by the investigator.

    Secondary assessments include the duration of response, disease control rate, progression-free survival, overall survival, and the occurrence of adverse events. Pharmacokinetics and immunogenicity of the treatment are also evaluated.

  4. Step 4

    Follow-up

    Follow-up involves continued monitoring of the patient's health status and any long-term effects of the treatment. This phase ensures that any late-onset side effects are identified and managed appropriately.

Who can join the trial?

9 criteria

  • The patient must have a type of cancer that is either **locally advanced**, **unresectable**, or **metastatic**. This means the cancer has spread and cannot be removed by surgery.
  • The patient must have one of the following types of cancer: biliary tract, bladder, cervical, endometrial, epithelial ovarian, pancreatic, or a rare tumor that expresses **HER2** (a protein that can affect cancer growth).
  • The patient must have tried previous treatments that did not work or have no other good treatment options available.
  • The patient may have had previous treatments that target **HER2**.
  • The presence of **HER2** in the tumor must be confirmed by a test, which can be done locally or centrally.
  • The patient must have a measurable disease, which means the cancer can be measured by the doctor using specific guidelines called **RECIST version 1.1**.
  • The patient must have organs that are working well enough, including the heart, kidneys, and liver.
  • The patient must be within the age range of 18 to 64 years old.
  • Both male and female patients can participate.

Who cannot join the trial?

5 criteria

  • Patients who do not have tumors that express HER2. HER2 is a protein that can affect the growth of some cancer cells.
  • Patients whose tumors can be surgically removed. "Unresectable" means the tumor cannot be removed with surgery.
  • Patients who do not have metastatic tumors. "Metastatic" means the cancer has spread to other parts of the body.
  • Patients who are not within the specified age range for the study.
  • Patients who are considered part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

Trastuzumab Deruxtecan (T-DXd, DS-8201a) is a medication being studied for its effectiveness and safety in treating certain types of tumors that express the HER2 protein. It is used in patients whose tumors have spread to other parts of the body or cannot be surgically removed. This medication works by targeting and binding to the HER2 protein on cancer cells, delivering a chemotherapy drug directly to the cancer cells to help destroy them.

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 and safety in treating certain types of tumors that express the HER2 protein. The main therapeutic use of Trastuzumab Deruxtecan is for patients with metastatic or unresectable tumors that have high levels of HER2. At the molecular level, it works by binding to the HER2 protein on cancer cells, delivering a chemotherapy drug directly to the cells, which helps to kill them. It is classified as an antibody-drug conjugate, combining targeted therapy with chemotherapy.

Investigated diseases

HER2 Expressing Tumors – These are tumors that have an overexpression of the human epidermal growth factor receptor 2 (HER2) protein. This overexpression can lead to more aggressive tumor growth and spread. HER2 expressing tumors are commonly found in certain types of breast cancer, but they can also occur in other cancers such as gastric cancer. The progression of these tumors can vary, but they often grow and spread more quickly than tumors without HER2 overexpression. The presence of HER2 can influence the behavior of the tumor and its response to certain treatments. Understanding the role of HER2 is crucial in managing and studying these types of tumors.
Trial detailsLast updated 8 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-504721-39-02Protocol codeD967VC00001Estimated enrolment453 patientsSponsorAstraZeneca AB

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