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Study on Raludotatug Deruxtecan for Patients with Advanced or Metastatic Solid Tumors, Including Gynecological and Genitourinary Cancers

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 Raludotatug Deruxtecan, also known by its code name DS-6000a. The trial is designed to evaluate the treatment's effectiveness and safety in people with advanced or metastatic solid tumors. These tumors include certain types of gynecological cancers such as endometrial cancer, cervical cancer, and non-high-grade serous ovarian cancer, as well as genitourinary cancers like urothelial cancer and clear cell renal cell carcinoma (ccRCC).

The purpose of the study is to assess how well Raludotatug Deruxtecan works in treating these cancers and to monitor any side effects. Participants in the study will receive the treatment through an intravenous infusion, which means the medication is given directly into a vein. The study will follow participants over a period to observe the treatment's impact on their cancer and overall health.

Throughout the trial, researchers will focus on understanding how the treatment affects the size and growth of the tumors, as well as any changes in the participants' health. The study aims to provide valuable information on the potential benefits and risks of using Raludotatug Deruxtecan for these types of cancers, contributing to future treatment options for patients with advanced or metastatic solid tumors.

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 trial

    Upon joining the trial, you will be asked to provide a pre-treatment biopsy from a primary or metastatic lesion. This is a small sample of tissue that helps in understanding your condition better.

    You will also need to have at least one measurable lesion that has not been previously treated with radiation.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to evaluate your overall health status. This includes checking your Eastern Cooperative Oncology Group (ECOG) performance status, which is a scale used to assess how your disease affects your daily living abilities.

    Your medical history will be reviewed to ensure you meet the specific criteria for the trial, such as having progressed after previous treatments.

  3. Step 3

    Treatment administration

    You will receive the medication Raludotatug Deruxtecan through an intravenous infusion. This means the medication will be given directly into your vein as a solution.

    The dosage, frequency, and duration of the administration will be determined by the trial protocol and your specific medical condition.

  4. Step 4

    Ongoing monitoring

    Throughout the trial, regular monitoring will be conducted to assess the effectiveness and safety of the treatment. This includes regular check-ups and imaging tests to measure the response of your tumors.

    You will be monitored for any side effects or adverse reactions to the treatment, ensuring your safety and well-being.

  5. Step 5

    Completion of trial

    At the end of the trial, a final assessment will be conducted to evaluate the overall outcomes of the treatment.

    You will be informed about the results and any further steps or follow-up care that may be necessary.

Who can join the trial?

10 criteria

  • Adults who are 18 years or older on the day of signing the consent form. If the legal age for consent is higher than 18, follow local rules.
  • For the ccRCC cohort (a type of kidney cancer): Must have a confirmed diagnosis of ccRCC that cannot be removed by surgery or has spread to other parts of the body. Must have been treated with no more than 3 previous treatments, including a PD-(L)1 checkpoint inhibitor and a VEGF-TKI, either one after the other or together.
  • Must have at least one tumor that has not been treated with radiation, which can be biopsied (a small sample taken for testing), and must agree to provide a biopsy sample before treatment.
  • Must have at least one tumor that can be measured according to specific guidelines (RECIST version 1.1).
  • Must have shown tumor growth on a scan after the most recent treatment.
  • Must have an ECOG performance status of 0 or 1, which means the person is fully active or has some symptoms but does not need bed rest during the day.
  • For the endometrial cancer cohort: Must have a confirmed diagnosis of endometrial cancer, regardless of specific genetic features. Must have shown disease progression after at least one treatment, including a platinum-based chemotherapy and an anti-PD-1 therapy, but no more than three treatments.
  • For the cervical cancer cohort: Must have a confirmed diagnosis of recurrent or persistent cervical cancer. Must have shown disease progression after at least one previous treatment that includes systemic therapy.
  • For the non-HGSOC cohort (a type of ovarian cancer): Must have a confirmed diagnosis of certain types of ovarian cancer that cannot be removed by surgery or has spread. Must have been treated with at least one previous treatment.
  • For the urothelial cancer cohort (a type of bladder cancer): Must have a confirmed diagnosis of urothelial carcinoma that cannot be removed by surgery or has spread. Must have shown disease progression after at least one previous treatment, including anti-PD-(L)1 therapy, but no more than three treatments.

Who cannot join the trial?

4 criteria

  • Patients with **advanced or metastatic solid tumors** cannot participate. This includes certain types of **gynecological cancers** like endometrial cancer, cervical cancer, and non-high-grade serous ovarian cancer, as well as **genitourinary cancers** like urothelial cancer and ccRCC.
  • Patients who are not within the specified **age range** for the study.
  • Patients who are not part of the specified **clinical trial groups**.
  • Patients who are part of a **vulnerable population** that the study does not include.
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Investigated drugs

Raludotatug Deruxtecan (R-DXd) is a medication being studied for its potential to treat advanced or metastatic solid tumors. This means it is being tested to see if it can help shrink or control tumors that have spread to other parts of the body. The trial is looking at how well this medication works in different types of cancer and how safe it is for patients to use. The goal is to see if it can improve the condition of patients with these serious types of cancer. The medication is given to patients, and researchers are closely monitoring how their tumors respond and any side effects they might experience.

What is already known about the treatment

Raludotatug Deruxtecan (R-DXd) – This medication is administered intravenously, meaning it is given through a vein, typically in a hospital or clinical setting. It is currently being studied in clinical trials for its effectiveness and safety in treating advanced or metastatic solid tumors, including certain types of gynecological and genitourinary cancers. R-DXd works by delivering a potent anti-cancer agent directly to cancer cells, which helps to stop their growth and spread. It belongs to a class of drugs known as antibody-drug conjugates, which are designed to target and kill cancer cells while minimizing damage to healthy cells.

Investigated diseases

  • Endometrial Cancer

    Endometrial cancer originates in the lining of the uterus, known as the endometrium. It typically begins with abnormal cell growth in this lining, which can form a tumor. As the disease progresses, the cancerous cells may invade deeper layers of the uterus and potentially spread to nearby organs. Over time, it can metastasize to distant parts of the body, such as the lungs or liver. The progression is often marked by symptoms like unusual vaginal bleeding or discharge.

  • Cervical Cancer

    Cervical cancer starts in the cells of the cervix, the lower part of the uterus that connects to the vagina. It usually develops slowly, beginning with precancerous changes that can be detected through screening. If untreated, these changes can progress to invasive cancer, spreading into the deeper tissues of the cervix and nearby areas. Advanced stages may involve the spread to distant organs. Symptoms often include irregular bleeding, pelvic pain, or pain during intercourse.

  • Non-High-Grade Serous Ovarian Cancer

    This type of ovarian cancer arises from the cells on the surface of the ovary. It is characterized by slower growth compared to high-grade serous ovarian cancer. The disease may initially be confined to the ovaries but can spread to the pelvis and abdomen. As it progresses, it can affect other organs, leading to symptoms like abdominal bloating, pain, and changes in bowel habits.

  • Urothelial Cancer

    Urothelial cancer, also known as transitional cell carcinoma, primarily affects the bladder but can also occur in the ureters and renal pelvis. It begins in the urothelial cells lining these organs. The disease can progress from superficial layers to deeper muscle layers and potentially spread to other parts of the body. Symptoms often include blood in the urine, frequent urination, and pain during urination.

  • Clear Cell Renal Cell Carcinoma (ccRCC)

    Clear cell renal cell carcinoma is a type of kidney cancer that originates in the renal cortex. It is characterized by the presence of clear cells when viewed under a microscope. The disease can grow into a large mass within the kidney and may invade nearby tissues or spread to distant organs. Symptoms may include blood in the urine, flank pain, and a palpable mass in the abdomen.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-513307-13-00Protocol codeDS6000-126Estimated enrolment200 patientsSponsorDaiichi Sankyo Inc.

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