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Study on Datopotamab Deruxtecan and Drug Combination for Patients with Advanced or Metastatic Endometrial, Gastric, Prostate, Ovarian, Colorectal, Urothelial, and Biliary Tract Cancers

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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 effectiveness and safety of a treatment called Datopotamab Deruxtecan (also known as Dato-DXd) for patients with advanced or metastatic solid tumors. The types of cancer being studied include Endometrial Cancer, Gastric Cancer, Metastatic Castration-resistant Prostate Cancer, Ovarian Cancer, Colorectal Cancer, Urothelial Cancer, and Biliary Tract Cancer. The trial will explore Dato-DXd both as a standalone treatment and in combination with other anticancer medications.

In addition to Dato-DXd, the study involves several other medications, including Prednisolone, Capecitabine, Rilvegostomig (code name AZD2936), Volrustomig (code name MEDI5752), Bevacizumab, Fluorouracil, Calcium Folinate, Cisplatin, Carboplatin, Infliximab, and Mycophenolate Mofetil. These medications are used in various combinations to assess their impact on the cancers mentioned. Some of these drugs are given orally, while others are administered through intravenous infusion.

The purpose of the study is to evaluate how well Dato-DXd works in shrinking tumors and to monitor any side effects that may occur. Participants will receive either Dato-DXd alone or in combination with other drugs, or a placebo. The study will involve regular check-ups and assessments to track the progress of the treatment and any changes in the participants' health. The trial is expected to continue until August 2026, with recruitment starting in May 2024.

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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

    Blood tests and imaging studies such as CT or MRI scans are performed to establish a baseline for the study.

  2. Step 2

    Treatment phase

    The treatment phase involves the administration of Datopotamab Deruxtecan (Dato-DXd) either as a standalone treatment or in combination with other anticancer agents.

    The medication is administered through an intravenous infusion. The frequency and dosage depend on the specific treatment plan assigned.

  3. Step 3

    Monitoring and follow-up

    Regular monitoring is conducted to assess the response to treatment. This includes physical examinations, blood tests, and imaging studies.

    The objective is to evaluate the objective response rate (ORR) and monitor any side effects or adverse reactions.

  4. Step 4

    End of treatment evaluation

    At the end of the treatment phase, a comprehensive evaluation is performed to determine the overall effectiveness of the treatment.

    This includes a final set of imaging studies and laboratory tests to compare with the initial baseline assessments.

  5. Step 5

    Long-term follow-up

    Participants may be required to attend follow-up visits to monitor long-term outcomes and any delayed side effects.

    These visits may continue for several months after the completion of the treatment phase.

Who can join the trial?

13 criteria

  • Participants must be male or female and at least 18 years old at the time of screening.
  • Female participants must be either 1 year post-menopausal, surgically sterile, or using a highly effective form of birth control. Women who can still have children must agree to use a highly effective method of birth control or avoid intercourse. They should have been stable on their chosen method of birth control for at least 3 months before joining the study and continue for at least 7 months after the last dose of the study drug. They must not donate or retrieve eggs for their own use during the study and for at least 7 months after the last dose. Consider preserving eggs before joining the study.
  • Male participants who plan to be sexually active with a female partner who can have children must be surgically sterile, avoid intercourse, or use a highly effective method of contraception from the time of screening throughout the study and for at least 4 months after the last dose of the study drug (6 months for France). The female partner should also use a highly effective contraception method to prevent pregnancy. Male participants must not freeze or donate sperm during the study and for at least 4 months after the last dose (6 months for France). Consider preserving sperm before joining the study. For certain study groups involving specific drugs, at least 6 months after the last dose will be required.
  • Participants must be able to give signed informed consent.
  • Participants must provide signed and dated written consent for optional genetic research before collecting samples for genetic research.
  • Participants must have a confirmed advanced or metastatic cancer, which means the cancer has spread to other parts of the body.
  • Participants must have a performance status of 0 or 1 according to the Eastern Cooperative Oncology Group, meaning they are fully active or have some symptoms but can still do light work. There should be no deterioration in their condition over the previous 2 weeks before starting the study.
  • Participants must provide a sample of their tumor tissue for analysis.
  • Participants must have at least one tumor that has not been treated with radiation and can be accurately measured using a CT or MRI scan. The tumor must be at least 10 mm in size, except for lymph nodes, which must be at least 15 mm. Some study groups allow participants with bone cancer that cannot be measured in the same way.
  • Participants must have adequate bone marrow and organ function within 7 days before starting the study. This includes specific levels of hemoglobin, neutrophils, platelets, serum albumin, and other blood tests. Certain medications or treatments are not allowed before these tests.
  • Participants must have a minimum life expectancy of 12 weeks.
  • At the time of screening, contraceptive use by men or women should follow local regulations for those participating in clinical studies.
  • All women who can have children must have a negative pregnancy test during screening.

Who cannot join the trial?

4 criteria

  • Patients with certain types of cancer, such as Endometrial Cancer, Gastric Cancer, Metastatic Castration-resistant Prostate Cancer, Ovarian Cancer, Colorectal Cancer, Urothelial Cancer, and Biliary Tract Cancer, may not be eligible.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
  • Patients who do not meet other specific health or medical criteria set by the study.
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Investigated drugs

Datopotamab Deruxtecan (Dato-DXd) is a medication being studied for its effectiveness and safety in treating advanced or metastatic solid tumors. It is being tested both as a standalone treatment and in combination with other cancer-fighting drugs. The goal is to see how well it works in shrinking tumors and to understand any side effects it might cause.

What is already known about the treatment

Datopotamab Deruxtecan – This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness and safety in treating various advanced or metastatic solid tumors, including endometrial, gastric, prostate, ovarian, colorectal, urothelial, and biliary tract cancers. It is in the investigational stage, with ongoing research to determine its full potential in medical practice. The main therapeutic indication is for use in patients with these types of cancers. At the molecular level, Datopotamab Deruxtecan works by delivering a cytotoxic agent directly to cancer cells, utilizing an antibody-drug conjugate mechanism that targets specific proteins on the surface of these cells. It is classified pharmacologically as an antibody-drug conjugate, which combines the targeting capabilities of monoclonal antibodies with the cancer-killing ability of chemotherapy.

Investigated diseases

  • Endometrial Cancer

    This cancer begins in the lining of the uterus, known as the endometrium. It often presents with abnormal vaginal bleeding, especially after menopause. As it progresses, it may cause pelvic pain and weight loss. The disease can spread to nearby tissues and organs if not addressed.

  • Gastric Cancer

    Also known as stomach cancer, it starts in the stomach lining and can grow into a tumor. Early symptoms might include indigestion and stomach discomfort. As it advances, it can lead to weight loss, nausea, and difficulty swallowing. The cancer may spread to other parts of the body over time.

  • Metastatic Castration-resistant Prostate Cancer

    This is a form of prostate cancer that continues to grow despite low testosterone levels. It often spreads to bones and lymph nodes, causing pain and fatigue. The disease can lead to urinary issues and bone fractures as it progresses.

  • Ovarian Cancer

    This cancer originates in the ovaries and is often detected at a later stage. Symptoms may include bloating, pelvic pain, and changes in bowel habits. As it progresses, it can spread to the abdomen and other organs, causing more severe symptoms.

  • Colorectal Cancer

    This cancer affects the colon or rectum and often begins as benign polyps. Symptoms can include changes in bowel habits, blood in the stool, and abdominal discomfort. As it advances, it may cause weight loss and fatigue, and can spread to other parts of the body.

  • Urothelial Cancer

    Also known as bladder cancer, it starts in the cells lining the bladder. Early signs include blood in the urine and frequent urination. As it progresses, it can cause pelvic pain and spread to nearby organs and lymph nodes.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-509436-26-00Protocol codeD926UC00001Estimated enrolment454 patientsSponsorAstraZeneca AB

sourced from the EU Clinical Trials Register and site verification

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