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Comparing AZD5335 with Mirvetuximab Soravtansine or a drug combination in patients with platinum-resistant ovarian cancer

Fast replyRegistered drugNo placebo
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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 of a new drug called AZD5335 against other available treatments for individuals with Advanced Platinum-resistant Epithelial Ovarian Cancer. This type of cancer is a form of Ovarian Cancer where the disease has returned or continued to grow despite being treated with platinum-based medications. The study focuses on how much a specific protein, known as FRα, is present in the tumor cells. Patients are divided into groups based on whether they have high or low levels of this protein.

For those with a high amount of the protein, AZD5335 will be compared to mirvetuximab soravtansine. For those with a low amount of the protein, AZD5335 will be compared to a treatment chosen by the doctor, which may include doxorubicin hydrochloride, liposomal, topotecan, or paclitaxel. These treatments are delivered through an intravenous infusion, which means the medicine is passed directly into a vein.

During the study, participants will receive their assigned treatment and will be monitored to see how long the cancer remains stable without growing. This period is referred to as progression-free survival. The study also looks at overall survival, which is the total length of time from the start of the study until death from any cause.

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

    <b>study participation</b>

    After joining the study, a randomization process occurs. this is a method used to assign you to a specific treatment group.

    The treatment received depends on the level of frα (folate receptor alpha, a protein found on certain cancer cells) expression in the tumor.

  2. Step 2

    <b>treatment for high frα expression</b>

    If the tumor has high frα expression, one of two treatments is provided via intravenous infusion (a liquid medicine delivered directly into a vein).

    The first option is azd5335, which is administered as a solution for infusion.

    The second option is mirvetuximab soravtansine, which is administered at a dose of 6 mg/kg (milligrams per kilogram of body weight) via intravenous infusion.

  3. Step 3

    <b>treatment for low frα expression</b>

    If the tumor has low frα expression, one of two treatment paths is chosen. the second path is determined by the doctor's choice of chemotherapy (medicine used to kill cancer cells).

    The first option is azd5335, which is administered as a solution for infusion.

    The second option involves investigator's choice chemotherapy, which may include medications such as paclitaxel at 80 mg/m2 (milligrams per square meter of body surface area), topotecan at 4 mg/m2, or doxorubicin hydrochloride, liposomal at 40 mg/m2, all delivered via intravenous infusion.

  4. Step 4

    <b>monitoring and evaluation</b>

    The progress of the condition is monitored through radiographic progression assessment (using imaging tests like scans) and tracking progression-free survival, which is the time from randomization until the cancer grows or death occurs.

    The study also tracks overall survival, which is the total time from randomization until death from any cause.

Who can join the trial?

9 criteria

  • You must have a confirmed diagnosis of high-grade serous epithelial ovarian cancer (a specific type of ovarian cancer), primary peritoneal cancer (cancer starting in the lining of the abdomen), or fallopian tube cancer.
  • You must have platinum-resistant disease, which means the cancer has continued to grow or spread despite being treated with platinum-based therapies (a common type of chemotherapy).
  • If you have only had one previous treatment with platinum, you must have completed at least 4 cycles of that treatment, showed a positive response, and then had the cancer grow back between 3 and 6 months after your last dose.
  • If you have had 2 or 3 previous treatments with platinum, your cancer must have grown back within 6 months after your last dose.
  • Your cancer must have been shown to grow or spread on radiological imaging (such as a CT or MRI scan) after your most recent treatment.
  • You must have received at least one, but no more than three, previous systemic therapies (treatments that travel through the entire body, such as chemotherapy) to treat your cancer.
  • It must be appropriate for you to receive a single-agent therapy (a treatment using only one type of medicine) as your next step of care.
  • If you have a documented BRCA mutation (a change in the genes that can increase cancer risk), you must have previously taken PARP inhibitors (a type of targeted drug used to treat certain cancers) if it is recommended by medical guidelines, unless you cannot take them for medical reasons.
  • You must be able to provide an FFPE tumor tissue sample (a method where a small piece of tumor tissue is preserved in wax to be studied in a lab).

Who cannot join the trial?

7 criteria

  • You cannot join if your cancer is a specific type, such as endometrioid, clear cell, mucinous, sarcomatous, mixed tumours, low-grade, or borderline ovarian tumours, which refer to the specific way the cancer cells look under a microscope.
  • You cannot join if your cancer is primary platinum-refractory, which means the cancer did not respond to platinum-based chemotherapy or it grew back within 3 months after you finished your first round of that treatment.
  • You cannot join if you have active or long-term corneal disorders (problems with the clear front part of the eye), a history of corneal transplantation (eye surgery to replace the clear front part of the eye), or any eye conditions that need constant medical care.
  • You cannot join if you have signs or symptoms of a bowel obstruction, which is a blockage in the intestine that prevents food or liquid from passing through.
  • You cannot join if you have non-infectious ILD or pneumonitis, which are types of lung inflammation or scarring not caused by an infection, especially if you have needed steroids (strong anti-inflammatory medicine) or supplemental oxygen to breathe.
  • You cannot join if you have previously used any FRα-targeted therapy (medicine designed to attack a specific protein called FRα) or TOP1i ADC (a specific type of targeted drug).
  • You cannot join if you have had a major surgical procedure within 4 weeks before taking the first dose of the study medicine.
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Investigated drugs

  • AZD5335

    is the experimental treatment being tested in this study to see how well it works in treating certain types of ovarian cancer.

  • Mirvetuximab soravtansine

    is a medication used as a comparison to help determine the effectiveness of the experimental treatment in patients whose tumors have high levels of a specific protein.

  • Doxorubicin

    is a type of chemotherapy medication used as a comparison to help evaluate how the experimental treatment performs against standard cancer treatments.

  • Topotecan

    is a chemotherapy drug used as a comparison to help measure the effectiveness of the experimental treatment.

  • Paclitaxel

    is a chemotherapy medication used as a comparison to help assess the performance of the experimental treatment in patients.

What is already known about the treatment

  • Mirvetuximab soravtansine

    This medication is an approved drug administered through an intravenous infusion to treat certain types of ovarian cancer. It belongs to a class of drugs called antibody-drug conjugates, which work by attaching to a specific protein found on the surface of cancer cells. Once the drug attaches to these cells, it releases a powerful chemical that enters the cell and prevents it from dividing, ultimately leading to cell death.

  • Doxorubicin hydrochloride, liposomal

    This is a specialized form of chemotherapy administered via intravenous infusion, commonly used to treat various types of cancer. It is categorized as an anthracycline and works by entering cancer cells to interfere with the cell's ability to copy its genetic material. By blocking this process, the medication prevents the cancer cells from growing and multiplying.

  • AZD5335

    This substance is currently being studied in clinical trials and is administered as a solution through an intravenous infusion. As an investigational drug, its exact classification and therapeutic uses are still being defined through ongoing research. It is designed to target specific molecular pathways within cancer cells to stop their growth and spread.

  • Topotecan

    This medication is a chemotherapy drug that is given to patients through an intravenous infusion to treat certain types of cancer. It belongs to a group of drugs known as topoisomerase inhibitors, which work by interfering with an enzyme that helps cancer cells manage their DNA. By disrupting this enzyme, the drug prevents the cancer cells from repairing their genetic code, causing them to die.

  • Paclitaxel

    This is a well-established chemotherapy medication administered through an intravenous infusion for the treatment of various cancers. It belongs to a class of drugs called taxanes, which work by stabilizing the internal structure of cancer cells. By preventing these cells from rearranging their structural proteins, the drug stops them from dividing and growing.

Investigated diseases

Platinum-resistant epithelial ovarian cancer - This is a type of cancer that begins in the tissues of the ovaries. It is characterized by the disease continuing to grow or spreading despite having been treated with platinum-based medications. The condition involves the abnormal and uncontrolled growth of cells within the ovarian structure. As the disease progresses, these cancerous cells can spread to other parts of the abdomen or pelvis. The rate of spread may vary depending on the specific characteristics of the tumor cells.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-520466-22-00Protocol codeD8991C00001Estimated enrolment1 100 patientsSponsorAstraZeneca AB

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