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Study of Patritumab Deruxtecan for Patients with Brain Metastases from Advanced Breast or Lung Cancer and Leptomeningeal Disease from Solid 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 treatment called Patritumab deruxtecan, also known by its code name HER3-DXd. The study is designed for patients with certain types of cancer, specifically those with advanced breast cancer and non-small cell lung cancer that have spread to the brain, as well as patients with leptomeningeal carcinomatosis, a condition where cancer spreads to the membranes surrounding the brain and spinal cord. The purpose of the study is to evaluate how well this treatment works in these specific conditions.

Participants in the study will receive Patritumab deruxtecan as a solution through an intravenous infusion, which means it will be administered directly into the bloodstream. The study is organized into three groups, or cohorts, each focusing on different aspects of the treatment's effectiveness. The first two groups will look at how the treatment affects brain metastases, which are cancerous growths that have spread to the brain. The third group will focus on patients with leptomeningeal carcinomatosis, assessing their overall survival rate after three months of treatment.

The study will take place over a period of time, with regular monitoring to observe the treatment's effects. Participants will undergo various assessments, including imaging tests like MRI to track changes in their condition. The study aims to provide valuable information on the potential benefits of Patritumab deruxtecan for patients with these challenging cancer conditions.

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

    Upon joining the study, the patient will be required to provide written informed consent. This ensures understanding of the study's purpose and procedures.

    The patient must meet specific health criteria, including adequate bone marrow, liver, and kidney function, and must have resolved any acute side effects from previous cancer treatments.

  2. Step 2

    Initial assessment

    The patient will undergo an initial assessment to confirm eligibility. This includes a review of medical history and current health status.

    For women of childbearing potential, a negative pregnancy test is required before starting treatment.

  3. Step 3

    Treatment administration

    The patient will receive patritumab deruxtecan, a solution for infusion, administered intravenously. The dosage and frequency will be determined by the study protocol.

    The treatment aims to assess the response of brain metastases or leptomeningeal disease in patients with specific types of cancer.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring will be conducted to assess the patient's response to the treatment and to manage any side effects.

    The patient's overall health, including blood counts and organ function, will be regularly evaluated.

  5. Step 5

    Completion of treatment

    The treatment period will continue as per the study's schedule, with the estimated end date being September 30, 2025.

    Upon completion, the patient's response to the treatment will be thoroughly assessed, and any necessary follow-up care will be arranged.

Who can join the trial?

21 criteria

  • The patient must understand the purpose of the study and sign a written consent form before starting any study procedures.
  • The patient must have proper functioning of the bone marrow, liver, and kidneys. For kidneys, this means a certain level of creatinine, a waste product, should be within a specific range.
  • For participants in certain groups, they must have received at least one previous treatment for advanced cancer. This varies depending on the type of cancer and specific genetic factors.
  • Any side effects from previous cancer treatments should be reduced to a mild level, except for hair loss or other non-risky side effects.
  • Women who can have children must agree to avoid pregnancy by using effective birth control methods during the study and for 7 months after the last treatment. They must also have a negative pregnancy test before starting the study and agree not to donate eggs during this time.
  • Men must agree to avoid fathering a child by using birth control methods during the study and for 4 months after the last treatment. They must also agree not to donate sperm during this time.
  • The patient must be available for treatment and follow-up visits.
  • For certain groups, the patient must have a confirmed diagnosis of specific types of breast cancer or lung cancer.
  • For certain groups, the patient must have newly diagnosed or progressing brain metastases, which are cancer cells that have spread to the brain.
  • For certain groups, the patient must have a measurable brain tumor of at least 10 mm on an MRI scan.
  • For certain groups, the patient must have a known HER2 status, which is a specific protein related to breast cancer.
  • The patient must be at least 18 years old.
  • For another group, the patient must have a confirmed diagnosis of any type of solid tumor.
  • For another group, the patient must have a specific type of leptomeningeal disease, which involves cancer spreading to the membranes surrounding the brain and spinal cord.
  • For another group, the patient must have newly diagnosed or progressing leptomeningeal disease after radiotherapy.
  • The patient must have a life expectancy of at least 6 weeks.
  • The patient must have a certain level of physical ability, measured by specific performance status scales.
  • The patient must be able to tolerate the therapy.
  • The patient must be willing to provide a recent tumor tissue sample for testing, if available.
  • The patient should not need immediate local therapy like brain surgery or radiotherapy.
  • The patient must have proper functioning of the bone marrow, liver, and kidneys, with specific blood cell counts and liver function tests within certain ranges.

Who cannot join the trial?

10 criteria

  • Patients with other types of cancer that are not specified in the study.
  • Patients who have received certain treatments that might interfere with the study results.
  • Patients with severe medical conditions that could make participation unsafe.
  • Patients who are unable to follow the study procedures or attend required visits.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients with a history of allergic reactions to the study medication.
  • Patients with certain infections that are not well controlled.
  • Patients with a history of drug or alcohol abuse that could affect their ability to participate.
  • Patients who are not able to provide informed consent, which means they cannot understand the study and agree to participate.
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Investigated drugs

Patritumab Deruxtecan (HER3-DXd) is a medication being studied for its potential to treat certain types of cancer. It is designed to target and deliver treatment directly to cancer cells that express a protein called HER3. This medication is being tested in patients with advanced breast cancer and non-small cell lung cancer that have spread to the brain, as well as in patients with advanced solid tumors that have spread to the lining of the brain and spinal cord. The goal of the trial is to see how well this medication can reduce the size of brain tumors and improve survival rates in these patients.

What is already known about the treatment

Patritumab Deruxtecan – This medication is administered intravenously, meaning it is given through a vein. It is currently being studied in clinical trials, specifically in a Phase II trial, to evaluate its effectiveness in treating certain types of cancer, including metastatic breast cancer and advanced non-small cell lung cancer with brain metastases, as well as solid tumors with leptomeningeal disease. The main therapeutic use of Patritumab Deruxtecan is to target and treat cancers that express the HER3 protein. At the molecular level, it works by binding to the HER3 receptor on cancer cells and delivering a chemotherapy agent directly to these cells, which helps to kill them. It is classified as an antibody-drug conjugate, which combines an antibody with a drug to specifically target cancer cells.

Investigated diseases

  • Metastatic Breast Cancer

    This is a type of breast cancer that has spread beyond the breast to other parts of the body, such as the bones, liver, lungs, or brain. It often progresses by forming new tumors in these distant organs. The disease can cause symptoms related to the affected areas, such as bone pain or difficulty breathing. Over time, the cancer cells may become resistant to treatments, leading to further spread and complications.

  • Advanced Non-Small Cell Lung Cancer

    This is a stage of lung cancer where the disease has spread beyond the lungs to other parts of the body. It typically progresses by forming metastases in organs such as the brain, liver, or bones. Symptoms may include persistent cough, chest pain, and difficulty breathing. As the disease advances, it can lead to significant health challenges and impact daily life.

  • Brain Metastases

    These are cancerous growths that have spread to the brain from primary tumors located elsewhere in the body. They can cause a variety of neurological symptoms, such as headaches, seizures, or changes in behavior. The progression of brain metastases can lead to increased pressure within the skull and further neurological complications. They are often associated with cancers like breast and lung cancer.

  • Leptomeningeal Disease

    This condition occurs when cancer cells spread to the membranes surrounding the brain and spinal cord. It can lead to symptoms such as headaches, nausea, and neurological deficits. The disease progresses by affecting the central nervous system, potentially leading to widespread neurological impairment. It is often seen in advanced stages of cancers like breast and lung cancer.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-503251-10-00Estimated enrolment60 patientsSponsorMedica Scientia Innovation Research S.L.

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