Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not yet recruiting

Study of Disitamab Vedotin for Adults with Previously Treated HER2-Positive Solid Tumors, Including Lung, Head and Neck, Ovarian, and Endometrial Cancers

Fast replyInvestigationalNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 Disitamab Vedotin on certain types of cancer. The cancers being studied include Non-Small Cell Lung Cancer, Squamous Cell Carcinoma of the Head and Neck, Ovarian Cancer, and Endometrial Cancer. These cancers are known to express a protein called HER2, which is involved in the growth of cancer cells. The treatment, Disitamab Vedotin, is a special type of medication that targets this protein to help fight the cancer.

The purpose of the study is to evaluate how well Disitamab Vedotin works in treating these cancers. Participants in the study will receive the treatment as a powder mixed into a solution, which is then given through an infusion. The study will follow participants over a period of time to observe the effects of the treatment on their cancer. Some participants may receive a placebo, which is a substance with no active medication, to compare the results.

Throughout the study, researchers will monitor the participants' health and any changes in their cancer. They will look at how the cancer responds to the treatment, any side effects that occur, and how long the effects last. The study aims to provide valuable information on the effectiveness and safety of Disitamab Vedotin for these types of cancer.

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 related to the type of cancer and previous treatments.

    The study involves patients with certain types of cancer, including non-small-cell lung cancer, squamous cell carcinoma of the head and neck, ovarian cancer, and endometrial cancer.

    Patients must have tumors that express a protein called HER2, which is determined through a test on tumor tissue.

  2. Step 2

    Treatment administration

    The treatment involves the administration of a medication called disitamab vedotin.

    This medication is provided as a powder for solution for infusion, meaning it is given through a drip into a vein.

    The frequency and dosage of the medication are determined by the study protocol and the patient's specific condition.

  3. Step 3

    Monitoring and assessments

    Throughout the study, regular assessments are conducted to monitor the response to the treatment.

    These assessments include measuring the size of the tumor and checking for any side effects.

    The study aims to evaluate the effectiveness of the treatment in controlling the disease and improving survival.

  4. Step 4

    Completion of the study

    The study is expected to continue until March 2028, with regular follow-ups to assess long-term outcomes.

    Upon completion, the results will be analyzed to determine the overall benefits and risks of the treatment.

Who can join the trial?

10 criteria

  • Must have one of the following types of cancer: non-small-cell lung cancer, squamous cell carcinoma of the head and neck, ovarian cancer, or endometrial cancer.
  • Cancer must be **unresectable**, meaning it cannot be removed by surgery, and must be locally advanced or have spread to other parts of the body (metastatic).
  • Must have received certain prior treatments, such as **platinum-based therapy** (a type of chemotherapy) and possibly anti-PD(L)1 therapy, depending on the type of cancer.
  • Must not have received more than a specific number of prior chemotherapy treatments for advanced disease, which varies by cancer type.
  • Cancer must show **HER2 expression**, which is a protein found on some cancer cells, at levels of 1+, 2+, or 3+ as determined by a test called IHC.
  • Must have **measurable disease** according to specific criteria used by doctors to assess cancer size and spread.
  • Must be able to provide a sample of tumor tissue for testing.
  • Must have an **ECOG performance status** score of 0 or 1, which indicates the ability to carry out daily activities.
  • Both male and female participants are eligible.
  • Participants must be within certain age ranges, typically adults.

Who cannot join the trial?

10 criteria

  • Patients who have not been previously treated for their cancer.
  • Patients with tumors that can be surgically removed.
  • Patients whose tumors do not express **HER2**, a protein that can affect the growth of cancer cells.
  • Patients who are not in the age range specified for the study.
  • Patients who are not able to provide informed consent or understand the study requirements.
  • Patients with other serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who are participating in another clinical trial at the same time.
  • Patients who have had a recent major surgery or are recovering from surgery.
  • Patients with a history of severe allergic reactions to similar treatments.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruitingNot recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Disitamab Vedotin is a medication being studied for its ability to treat certain types of cancer. It is used in patients who have already received treatment for their cancer, but the cancer has either spread or cannot be removed with surgery. This medication targets tumors that express a protein called HER2, which can promote the growth of cancer cells. The goal of using Disitamab Vedotin in this trial is to see how well it can reduce or control the growth of these tumors.

What is already known about the treatment

Disitamab Vedotin – This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating certain types of cancer, including non-small-cell lung carcinoma, squamous cell carcinoma of the head and neck, ovarian neoplasms, and endometrial neoplasms. It is an investigational drug, meaning it is not yet approved for general medical use but is being evaluated for its potential benefits. Disitamab Vedotin works by targeting and binding to the HER2 protein on cancer cells, delivering a toxic agent directly to the tumor, which helps to kill the cancer cells. It is classified as an antibody-drug conjugate, combining a monoclonal antibody with a chemotherapy drug to enhance its cancer-fighting capabilities.

Investigated diseases

  • Non-Small-Cell Lung Carcinoma

    This is a type of lung cancer that includes several subtypes, such as adenocarcinoma and squamous cell carcinoma. It generally grows and spreads more slowly than small-cell lung cancer. Symptoms may include a persistent cough, chest pain, and shortness of breath. As the disease progresses, it can spread to other parts of the body, including the bones and brain. It is often diagnosed at an advanced stage due to the subtlety of early symptoms.

  • Squamous Cell Carcinoma of Head and Neck

    This cancer originates in the squamous cells lining the moist surfaces inside the head and neck. It can affect areas such as the mouth, throat, and nose. Symptoms may include a sore throat, difficulty swallowing, and a lump in the neck. The disease can progress by invading nearby tissues and spreading to lymph nodes. It is often linked to risk factors like tobacco and alcohol use.

  • Ovarian Neoplasms

    These are tumors that occur in the ovaries, which can be benign or malignant. Malignant ovarian neoplasms, or ovarian cancer, often present with vague symptoms like bloating, pelvic pain, and changes in bowel habits. The disease can progress by spreading to the abdominal lining and other organs. Early detection is challenging due to the non-specific nature of symptoms.

  • Endometrial Neoplasms

    These are tumors that develop in the lining of the uterus, known as the endometrium. The most common type is endometrial carcinoma, which often presents with abnormal uterine bleeding, especially post-menopause. As the disease progresses, it can invade the uterine muscle and spread to other pelvic organs. Risk factors include obesity, hormone therapy, and a history of certain genetic conditions.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-504445-31-00Protocol codeC5731005 / SGNDV-005Estimated enrolment160 patientsSponsorSeagen Inc.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.