Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

A study comparing Rinatabart Sesutecan to other treatments in patients with endometrial cancer who have previously received platinum-based chemotherapy and PD-L1 therapy

Fast replyRegistered drugNo 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 study is being conducted to compare the effectiveness and safety of a new drug called rinatabart sesutecan against other treatments chosen by a doctor. The research focuses on individuals with endometrial cancer, which is a type of cancer that starts in the lining of the uterus. This study specifically involves patients whose cancer is advanced, has returned after previous treatment, or has spread to other parts of the body. The participants in this trial have previously received platinum-based chemotherapy and PD(L)-1 therapy, which are types of treatments used to kill cancer cells or help the immune system fight the disease.

In this study, participants will receive either rinatabart sesutecan or a treatment selected by their doctor, which may include medications such as doxorubicin or paclitaxel. These medications are administered through an IV infusion, a method where medicine is delivered directly into a vein through a small tube. The study aims to determine if the new drug works better than the standard options currently available for this condition.

During the course of the study, participants will undergo regular monitoring to track how the cancer responds to the medication and to observe any side effects. The researchers will look at how long the cancer remains stable without growing and the overall survival of the participants. This process involves continuous observation over several years to collect data on how the treatments affect the health and well-being of the individuals involved.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Treatment assignment

    Participation begins with the assignment to one of two different treatment paths to address endometrial cancer, which is a type of cancer that starts in the uterus.

    One path involves receiving the test medication, rinatabart sesutecan, administered through an intravenous infusion, which means the medicine is delivered directly into a vein.

    The other path involves receiving a treatment of investigator’s choice, where the doctor selects a therapy based on clinical judgment.

  2. Step 2

    Comparator treatment options

    If the investigator's choice includes specific comparison medications, doxorubicin may be administered via intravenous infusion at a dose of 60 mg/m2 (milligrams per square meter of body surface area).

    Alternatively, paclitaxel may be administered via intravenous infusion at a dose of 80 mg/m2 (milligrams per square meter of body surface area).

  3. Step 3

    Monitoring and follow-up

    The progress of the condition is monitored for up to approximately 3 years to evaluate progression-free survival, which refers to the length of time during and after treatment that the disease does not get worse.

    overall survival, which is the total length of time from the start of the trial that patients remain alive, is also tracked for up to approximately 3 years.

    The effectiveness of the treatment is measured by the objective response rate, which describes how much a tumor shrinks or disappears after receiving the medication.

Who can join the trial?

9 criteria

  • You must be female.
  • You must have endometrial cancer (cancer of the lining of the uterus) that has returned or is getting worse after previous treatment.
  • The cancer must be a specific type, meaning it cannot be neuroendocrine tumors, carcinosarcoma, or endometrial sarcoma (these are specific, different types of cancer cells).
  • The cancer must have been confirmed through a histology or cytology test (tests where a doctor looks at cells under a microscope to confirm the disease).
  • You must have had between 1 and 3 previous treatments for your cancer.
  • You must have previously received platinum-based chemotherapy (a type of cancer medicine that uses platinum) and a PD(L)-1 inhibitor (a type of immunotherapy, which is a drug that helps your immune system fight cancer).
  • If your cancer returned more than 12 months after your last platinum-based chemotherapy, you must receive more of this treatment unless it is not possible for you to have it.
  • If you are starting immunotherapy (treatment that uses the body's immune system) for the returning cancer, you do not have to receive more platinum-based chemotherapy.
  • Your cancer must have shown growth or spreading on radiographic imaging (pictures of the inside of your body, such as a CT scan or MRI) since your last treatment.

Who cannot join the trial?

6 criteria

  • You have previously received treatment using an antibody-drug conjugate (a type of medicine that uses an antibody to deliver a drug directly to cancer cells) that contains a topoisomerase 1 inhibitor (a substance that stops cancer cells from multiplying).
  • You have a current or past malignancy (cancer) other than the specific type of cancer being studied, or you have signs that a previous cancer is still present in your body. Certain minor cancers that are unlikely to spread or cause death, such as some skin cancers or cancers that were cured more than 3 years ago, may be allowed.
  • You have active cancer that has spread to your central nervous system (the brain and spinal cord) or have carcinomatous meningitis (a condition where cancer cells spread to the membranes covering the brain and spinal cord). People with treated brain cancer may join if they have been stable for 4 weeks and are not taking specific medications for brain symptoms.
  • You have had a gastrointestinal obstruction (a blockage in your stomach or intestines) that required hospital care or caused symptoms within the last 91 days.
  • You show signs of a blockage in your stomach or intestines on medical imaging tests during your screening.
  • You currently require parenteral nutrition (nutrients delivered directly into your veins rather than through eating).
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.

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

  • Rinatabart sesutecan

    is the experimental treatment being tested in this study to see how well it works against endometrial cancer.

  • Doxorubicin

    is a type of chemotherapy drug used as a comparison treatment to help evaluate the effectiveness of the study drug.

  • Paclitaxel

    is another chemotherapy drug used as a comparison treatment to help evaluate the effectiveness of the study drug.

What is already known about the treatment

  • Doxorubicin hydrochloride

    This medication is an anticancer drug administered through an intravenous infusion into the bloodstream. It is a well-established treatment used to manage various types of cancer by entering cancer cells and interfering with their ability to copy their genetic material, which prevents the cells from multiplying. Classified as an anthracycline antibiotic, it works by damaging the DNA of rapidly growing cells to stop tumor growth.

  • Rinatabart sesutecan

    This experimental drug is given as a solution through an intravenous infusion and is currently being studied in clinical trials. It is designed to target specific proteins on the surface of cancer cells to help the immune system recognize and destroy them more effectively. As a targeted therapy, it aims to provide a more precise way to treat advanced cancers compared to traditional methods.

  • Paclitaxel

    This medication is an anticancer agent administered via intravenous infusion to treat several types of cancer. It is a widely used drug in medical practice that works by stopping cancer cells from dividing, specifically by stabilizing the internal structure that allows cells to split. It is classified as a taxane and functions by freezing the cell's growth machinery, eventually leading to the death of the cancer cell.

Investigated diseases

Endometrial cancer - This disease occurs when abnormal cells begin to grow in the lining of the uterus. These cells can multiply uncontrollably and form a mass. The condition can start in one specific area or spread to other parts of the uterine lining. It may also progress to involve nearby tissues or move to distant parts of the body. Over time, the abnormal growth can continue to expand and change the structure of the uterine environment.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519818-31-01Protocol codeGCT1184-03Estimated enrolment660 patientsSponsorGenmab A/S

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.