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Study on Long-Term Safety of Trastuzumab Deruxtecan for Patients with Advanced HER2-Positive or HER2-Mutated Solid Tumors

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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 long-term safety of a treatment for people with advanced cancers known as HER2-expressing or HER2-mutated solid tumors. These are types of cancers that have specific changes in a protein called HER2, which can affect how the cancer grows. The treatment being studied is a medication called trastuzumab deruxtecan, also known by its code name DS-8201a. This medication is given as a solution through an infusion into the veins.

The purpose of the study is to provide continued access to this treatment for patients who are benefiting from it and to monitor its long-term safety. Participants in this study will continue to receive the medication as long as they are experiencing positive effects from it. The study will track any side effects or health changes that occur during this time.

Throughout the study, participants will receive regular infusions of the medication and will be monitored by healthcare professionals to ensure their safety. The study aims to gather information on any adverse events, which are unexpected health issues that might arise from the treatment. This information will help in understanding the long-term effects of the medication and ensuring it is safe for continued use in treating these types of cancers.

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

    Participation begins after enrollment in a previous study sponsored by DS or DS/AZ, which has reached its end-of-study definition.

    Eligibility requires no evidence of disease progression and a clinical benefit from the study drug as assessed by an investigator.

  2. Step 2

    Treatment administration

    The study involves the administration of the drug trastuzumab deruxtecan, also known as DS-8201a.

    The drug is given as a solution for infusion through an intravenous route.

    The frequency and duration of administration are determined based on ongoing clinical benefit and safety assessments.

  3. Step 3

    Safety monitoring

    Long-term safety is monitored throughout the study.

    Monitoring includes tracking any adverse events that may lead to discontinuation or dose reduction of the study drug.

  4. Step 4

    Contraception and reproductive considerations

    Participants of reproductive potential must use effective contraception or avoid intercourse during the study and for a specified period after the last dose: 7 months for females and 4 months for males.

    Females must have a negative pregnancy test at screening, during treatment, and for 7 months after the last dose.

    Males must not donate sperm, and females must not donate or retrieve ova during the study and for the specified period after.

  5. Step 5

    Study duration

    The study is estimated to end by December 1, 2027.

    Recruitment for the study is expected to start on February 1, 2024.

Who can join the trial?

7 criteria

  • You must be currently enrolled in a specific study sponsored by DS or DS/AZ that has reached a certain stage.
  • You should not have any signs of the disease getting worse and must be benefiting from the treatment according to the study investigator.
  • If you are a male or female who can have children, you must agree to use a very effective form of birth control or avoid sexual intercourse during the study and for a certain period after the last dose of the study drug. For females, this is at least 7 months, and for males, it is at least 4 months.
  • If you are a female who can have children, you must have a negative pregnancy test before starting the study, during the treatment, and for 7 months after the last dose of the study drug.
  • Men must not freeze or donate sperm from the start of the study until at least 4 months after the last dose of the study drug.
  • Women must not donate or collect eggs for their own use from the start of the study until at least 7 months after the last dose of the study drug. They should also not breastfeed during this time.
  • You must sign and date a consent form before starting any study-related procedures and be willing to follow all study requirements.

Who cannot join the trial?

4 criteria

  • Patients who have a type of cancer that is not advanced or cannot be surgically removed.
  • Patients whose cancer does not show or have changes in a protein called HER2. This protein can affect how cancer grows.
  • Patients who are not benefiting from the study treatment anymore.
  • Patients who have not been monitored for long-term safety while on the study treatment.
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Investigated drugs

  • Study Drug A

    is a medication being tested to see if it can provide long-term benefits to patients who have already shown improvement with its use in previous studies. The trial aims to ensure that patients can continue to receive this medication and to monitor its safety over an extended period.

  • Study Drug B

    is another medication included in the trial for patients who have been benefiting from it. The focus is on allowing these patients to keep using the drug while researchers gather more information about its long-term safety and effectiveness.

What is already known about the treatment

Trastuzumab – This medication is administered intravenously and is used primarily for treating certain types of cancer, specifically those that express or have mutations in the HER2 protein. It is currently well-established in medical practice and literature for its role in cancer therapy. Trastuzumab works by binding to the HER2 protein on the surface of cancer cells, inhibiting their growth and survival. It is classified as a monoclonal antibody, which is a type of targeted cancer therapy.

Investigated diseases

HER2-Positive Solid Tumors – These are a group of cancers that express or have mutations in the human epidermal growth factor receptor 2 (HER2) protein. HER2 is a protein that can promote the growth of cancer cells. In some cancers, high levels of HER2 are present, which can lead to more aggressive tumor growth. These tumors can occur in various parts of the body, including the breast, stomach, and other organs. The disease is characterized by its ability to spread to other parts of the body, making it more challenging to treat. The progression of the disease can vary depending on the location and extent of the tumor.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506330-73-00Protocol codeROMast-001Estimated enrolment134 patientsSponsorDaiichi Sankyo Inc.

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