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Study of Raludotatug Deruxtecan for Patients with Platinum-resistant High-grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

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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 a treatment for certain types of cancer that are resistant to platinum-based chemotherapy. The cancers being studied include high-grade serous ovarian cancer, high-grade endometrioid ovarian cancer, primary peritoneal cancer, and fallopian tube cancer. The treatment being tested is called Raludotatug Deruxtecan, also known by its code name DS-6000a. This is a type of medication known as an antibody-drug conjugate, which is designed to target specific cancer cells.

The purpose of the study is to evaluate how well Raludotatug Deruxtecan works compared to other treatments that doctors might choose, such as paclitaxel, doxorubicin hydrochloride, liposomal, gemcitabine hydrochloride, or topotecan. These are all medications that are commonly used to treat cancer. The study will involve participants receiving these treatments through an intravenous infusion, which means the medication is given directly into a vein.

Participants in the study will be randomly assigned to receive either Raludotatug Deruxtecan or one of the other treatments. The study will take place over a period of up to 24 months. During this time, participants will have regular visits to monitor their health and the effects of the treatment. The study aims to provide more information about the effectiveness and safety of Raludotatug Deruxtecan for treating these types of cancer.

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

    Enrollment

    Upon joining the study, the participant will be required to sign and date an informed consent form. This is a necessary step before any study-specific procedures can begin.

    A negative pregnancy test is required for females of childbearing potential within 72 hours before the first dose of the study drug. Participants must agree to use effective birth control during the study and for 7 months after the last dose.

  2. Step 2

    Initial assessment

    Participants will undergo a baseline assessment, which includes laboratory tests to ensure eligibility. This must be completed within 7 days before starting the study drug.

    Participants must have a documented diagnosis of high-grade ovarian, primary peritoneal, or fallopian tube cancer and must have at least one measurable lesion.

  3. Step 3

    Treatment phase 2

    In Phase 2, participants will receive Raludotatug Deruxtecan (R-DXd) through intravenous infusion. The objective is to evaluate the response rate at different dose levels.

    The treatment will be administered according to the study protocol, and participants will be monitored for their response to the drug.

  4. Step 4

    Treatment phase 3

    In Phase 3, participants will either continue with Raludotatug Deruxtecan (R-DXd) or receive one of the following treatments: paclitaxel, doxorubicin hydrochloride (liposomal), gemcitabine, or topotecan. All treatments are administered via intravenous infusion.

    The goal is to compare the response rate and progression-free survival between the different treatment options.

  5. Step 5

    Monitoring and follow-up

    Participants will have regular follow-up visits to monitor their health and response to the treatment. This includes imaging tests to evaluate the size of the cancer lesions.

    Participants must provide biopsy samples before and during treatment, except in Phase 3 where only a pretreatment biopsy is required.

  6. Step 6

    End of study

    The study is estimated to end by March 2028. Participants will be informed about the study results and any further steps if necessary.

    Participants are advised to continue using birth control for 7 months after the last dose of the study drug.

Who can join the trial?

15 criteria

  • Sign and date the informed consent form before starting any study-specific procedures.
  • Have an Eastern Cooperative Oncology Group performance status of 0 or 1, which is a way to measure how well you can perform daily activities.
  • Provide necessary local laboratory data within 7 days before starting the study drug.
  • If you are a female who can have children, you must have a negative pregnancy test 72 hours before the first dose of the study drug and agree to use highly effective birth control during the study and for 7 months after the last dose. Male partners should also use additional barrier methods of contraception during this time.
  • Female participants must not donate or retrieve eggs for personal use from the time of screening, throughout the study, and for at least 7 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.
  • For Phase 3 only: Be eligible for one of the treatments in the Investigator's choice of chemotherapy and must not have received it before for ovarian cancer.
  • Be at least 18 years old or the minimum legal adult age, whichever is greater, at the time of signing the informed consent form.
  • Have a confirmed diagnosis of high-grade serous ovarian cancer, high-grade endometrioid ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
  • Have at least one lesion that has not been treated with radiation, which can be biopsied, and agree to provide a tissue sample before and during treatment (the on-treatment sample is not needed for Phase 3).
  • Have received at least 1 but no more than 3 previous systemic treatments for cancer.
  • Have platinum-resistant disease, meaning the cancer did not respond well to platinum-based treatments. Specific criteria apply based on the number of platinum treatments received.
  • Have had prior treatment with PARP inhibitors if you have a documented breast cancer gene mutation, unless you are not eligible for this treatment.
  • Have had prior treatment with mirvetuximab soravtansine if you have high-folate receptor alpha expression, unless you are not eligible due to precautions or intolerance, or if the treatment is not approved or available locally.
  • Have at least one measurable lesion that can be evaluated using imaging techniques like CT or MRI, according to specific criteria used to assess tumor response.

Who cannot join the trial?

3 criteria

  • Patients who have a different type of cancer than those specified in the study.
  • Patients who are not female, as the study is only for female participants.
  • Patients who are considered part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

  • Raludotatug Deruxtecan (R-DXd)

    is an experimental medication being studied for its potential to treat certain types of cancer, specifically ovarian, primary peritoneal, or fallopian tube cancer that is resistant to platinum-based treatments. It is a type of drug known as an antibody-drug conjugate, which means it combines an antibody with a drug to target and kill cancer cells more effectively.

  • Paclitaxel

    is a chemotherapy medication used to treat various types of cancer. It works by stopping cancer cells from dividing and growing, which can help to slow or stop the spread of cancer in the body.

  • Pegylated Liposomal Doxorubicin (PLD)

    is a form of chemotherapy that uses a special coating to help the drug stay in the body longer and target cancer cells more effectively. It is used to treat certain types of cancer, including ovarian cancer.

  • Gemcitabine

    is a chemotherapy drug that is used to treat several types of cancer. It works by interfering with the DNA of cancer cells, preventing them from growing and multiplying.

  • Topotecan

    is a chemotherapy medication used to treat certain types of cancer. It works by inhibiting an enzyme that cancer cells need to grow, thereby slowing or stopping the progression of the disease.

What is already known about the treatment

Raludotatug Deruxtecan (R-DXd) – This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating certain types of ovarian cancer, including platinum-resistant, high-grade serous ovarian cancer, high-grade endometrioid ovarian cancer, primary peritoneal cancer, and fallopian tube cancer. R-DXd is an antibody-drug conjugate that targets the CDH6 protein on cancer cells, delivering a cytotoxic agent directly to the tumor, which helps to kill cancer cells while minimizing damage to healthy cells. It is classified as an antineoplastic agent, specifically an antibody-drug conjugate.

Investigated diseases

  • Platinum-resistant high-grade serous ovarian cancer

    This type of ovarian cancer does not respond well to platinum-based chemotherapy, which is a common treatment. It is characterized by the rapid return of cancer after initial treatment. The cancer cells are high-grade, meaning they are more aggressive and grow quickly. This type of cancer often spreads to other parts of the body, making it more challenging to manage.

  • High-grade endometrioid ovarian cancer

    This is a subtype of ovarian cancer that originates from the cells lining the uterus. It is considered high-grade, indicating that the cancer cells are abnormal and grow rapidly. This type of cancer can be aggressive and may spread to other areas of the body. It is often diagnosed at an advanced stage due to its subtle early symptoms.

  • Primary peritoneal cancer

    This cancer develops in the peritoneum, a thin layer of tissue lining the abdomen. It is similar to ovarian cancer in terms of symptoms and treatment. The cancer cells can spread throughout the abdominal cavity, affecting various organs. It is often diagnosed at a later stage because it shares symptoms with other abdominal conditions.

  • Fallopian tube cancer

    This rare cancer starts in the fallopian tubes, which connect the ovaries to the uterus. It is often detected at an advanced stage due to non-specific symptoms. The cancer cells can spread to nearby organs and tissues. It shares similarities with ovarian cancer in terms of progression and symptoms.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2023-507914-28-00Protocol codeDS6000-109Estimated enrolment860 patientsSponsorDaiichi Sankyo Inc.

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