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Study of Patritumab Deruxtecan for Patients with Advanced or Metastatic 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, on patients with locally advanced or metastatic solid tumors. These are types of cancers that have either spread to nearby areas or to other parts of the body and cannot be removed by surgery or treated with radiation. The purpose of the study is to evaluate how effective this treatment is for these types of tumors.

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 will take place over a period of time, during which participants will have regular visits to receive the treatment and undergo various tests to monitor their health and the effects of the treatment. The study aims to gather information on how well the treatment works and any side effects that may occur.

Throughout the study, researchers will be looking at several outcomes, such as how long the treatment keeps the cancer from getting worse, how long any positive effects last, and the overall survival of participants. The study will also explore the relationship between the presence of a protein called HER3 in the tumors and the effectiveness of the treatment. This information will help in understanding the potential benefits of Patritumab deruxtecan for patients with these types of cancers.

The research process

The trial runs in 6 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 participant will sign and date the informed consent form (ICF) before any study-specific procedures begin.

    A separate consent for tissue screening will be obtained to meet the baseline tumor tissue requirement.

  2. Step 2

    Initial screening

    The participant will undergo initial screening to confirm eligibility, which includes providing a pretreatment tumor tissue sample and undergoing imaging tests like CT or MRI to identify measurable lesions.

    The participant's performance status will be assessed using the Eastern Cooperative Oncology Group (ECOG) scale, and adequate bone marrow and organ function will be confirmed through laboratory tests.

  3. Step 3

    Treatment administration

    The participant will receive the study medication, patritumab deruxtecan, administered as an intravenous infusion.

    The dosage and frequency of administration will be determined by the study protocol, and the treatment will continue as specified in the study guidelines.

  4. Step 4

    Monitoring and assessments

    Throughout the study, the participant will attend scheduled visits for monitoring and assessments, which include laboratory tests and imaging to evaluate the response to treatment.

    The primary endpoint is the overall response rate (ORR) as assessed by the investigator using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

  5. Step 5

    Safety evaluations

    Safety evaluations will be conducted to monitor for any treatment-emergent adverse events (TEAEs) and other safety parameters.

    The participant's health and response to the medication will be closely observed to ensure safety throughout the study.

  6. Step 6

    Study completion

    The study is estimated to end by October 31, 2026, with recruitment starting on May 29, 2024.

    Upon completion, the participant's overall survival and progression-free survival will be evaluated, along with other secondary endpoints such as duration of response and clinical benefit rate.

Who can join the trial?

18 criteria

  • Sign and date the consent form before starting any study-specific procedures. A separate consent for tissue screening is required to meet the baseline tumor tissue requirement.
  • If you are male, you must be surgically sterile or willing to use highly effective birth control during the study and for at least 4 months after the last dose of the study drug.
  • Male participants must not freeze or donate sperm from the start of the study until at least 4 months after the final dose of the study drug.
  • Be willing and able to attend scheduled visits, follow the drug administration plan, undergo laboratory tests, and comply with other study procedures and restrictions.
  • Participate in the Phase II open-label study.
  • Provide consent to participate in an interview sub-study through the consent form.
  • Agree to be audio recorded.
  • Live in Belgium, Spain, Japan, Korea, Taiwan, continental US (excluding Puerto Rico), UK, or Australia.
  • Be able to communicate and read fluently in the local language, such as Belgian-French, Spanish, Japanese, Korean, Taiwanese-Mandarin, or English.
  • Be physically able to participate in a one-on-one, approximately 45-minute telephone interview using an internet-enabled device with screen-sharing capabilities.
  • Be at least 18 years old (or older if local regulations require a higher age for consent).
  • Have locally advanced unresectable or metastatic disease, which means the disease cannot be cured by surgery or radiation.
  • Have at least one measurable lesion on a CT or MRI scan as assessed by the investigator.
  • Provide a pretreatment tumor tissue sample of sufficient quantity.
  • Have an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at screening, which indicates your ability to perform daily activities.
  • Have adequate bone marrow reserve and organ function based on local laboratory data within 14 days before starting the study.
  • If you are a female of childbearing potential, you must have a negative pregnancy test at screening and be willing to use highly effective birth control during the study and for 7 months after the last dose of the study drug.
  • Female participants must not donate or retrieve eggs for their own use from the start of the study until 7 months after the final dose of the study drug.

Who cannot join the trial?

8 criteria

  • Patients with other types of cancer that are not locally advanced or metastatic solid tumors cannot participate. Locally advanced means the cancer has spread from where it started to nearby tissue or lymph nodes. Metastatic means the cancer has spread to other parts of the body.
  • Patients who have received certain treatments for their cancer recently may not be eligible.
  • Patients with certain medical conditions that could interfere with the study treatment may be excluded.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who are unable to follow the study procedures or attend study visits may not be eligible.
  • Patients with a history of severe allergic reactions to similar drugs may be excluded.
  • Patients with uncontrolled infections or other serious illnesses may not be eligible.
  • Patients who have participated in another clinical trial recently may not be eligible.
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Investigated drugs

Patritumab Deruxtecan (HER3-DXd) is a medication being studied for its effectiveness in treating advanced or metastatic solid tumors. It is designed to target and deliver cancer-fighting agents directly to the tumor cells, potentially reducing the growth of the cancer. This study aims to understand how well this medication works when used alone in patients with specific types of advanced cancers.

What is already known about the treatment

Patritumab Deruxtecan – This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating locally advanced or metastatic solid tumors. It is in the experimental phase and is not yet widely used in standard medical practice. The main therapeutic indication is for various types of advanced solid tumors. Patritumab Deruxtecan works by targeting the HER3 receptor on cancer cells, delivering a cytotoxic agent directly to the tumor, which helps to inhibit tumor growth. It is classified as an antibody-drug conjugate, combining a monoclonal antibody with a chemotherapy drug.

Investigated diseases

Locally Advanced or Metastatic Solid Tumors – These are cancers that have either spread extensively within the local area or have metastasized to other parts of the body. In locally advanced cases, the tumor has grown significantly but remains within the region of origin, often involving nearby tissues or lymph nodes. Metastatic tumors have spread from the primary site to distant organs or tissues, indicating a more advanced stage of cancer. The progression of these tumors can vary widely depending on the type of cancer and its location. They often lead to symptoms related to the affected organs and can impact overall health and function. The behavior and growth rate of these tumors can differ, influencing how they affect the body over time.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-507641-29-00Protocol codeU31402-277Estimated enrolment740 patientsSponsorDaiichi Sankyo Inc.

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