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Study on the Effectiveness and Safety of Luveltamab Tazevibulin Compared to Chemotherapy in Women with Relapsed Platinum-resistant Ovarian 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 the effectiveness and safety of a new treatment called luveltamab tazevibulin (also known as STRO-002) for women with a type of cancer known as relapsed platinum-resistant epithelial ovarian cancer. This includes cancers that originate in the ovaries, fallopian tubes, or the lining of the abdomen, known as the peritoneum. The study will compare this new treatment to standard chemotherapy options chosen by the doctor, which may include medications like gemcitabine, paclitaxel, topotecan, or Caelyx (pegylated liposomal doxorubicin).

The purpose of the study is to evaluate how well luveltamab tazevibulin works compared to these standard treatments. Participants will receive either the new treatment or one of the standard chemotherapy options. The study will monitor the participants over a period of time to assess the treatment's impact on the cancer and any side effects that may occur. The study will also use a special test called the VENTANA FOLR1 CDx Assay to identify patients who might benefit from the new treatment. This test checks for the presence of a protein called folate receptor alpha in the cancer cells.

Throughout the study, participants will receive their assigned treatment and undergo regular check-ups to monitor their health and the cancer's response to the treatment. The study aims to provide valuable information on whether luveltamab tazevibulin can be a more effective option for treating this type of ovarian cancer compared to existing chemotherapy treatments. The study is expected to continue until 2027, with recruitment starting in 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

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria, including age, type of cancer, and previous treatments.

    A negative pregnancy test is required for participants of childbearing potential, and a commitment to avoid pregnancy during and after the study is necessary.

  2. Step 2

    Treatment assignment

    Participants are assigned to receive either luveltamab tazevibulin or a chemotherapy treatment chosen by the investigator.

    The chemotherapy options include gemcitabine, paclitaxel, topotecan, or pegylated liposomal doxorubicin.

  3. Step 3

    Treatment administration

    The medications are administered through an infusion, which involves delivering the drug directly into the bloodstream over a set period.

    The frequency and duration of the treatment depend on the specific medication and the treatment plan outlined by the healthcare provider.

  4. Step 4

    Monitoring and assessments

    Regular monitoring is conducted to assess the effectiveness of the treatment and to check for any side effects.

    This includes imaging tests to measure tumor response and blood tests to monitor overall health and organ function.

  5. Step 5

    Follow-up

    After completing the treatment phase, follow-up visits are scheduled to continue monitoring health status and any long-term effects of the treatment.

    Participants are encouraged to report any new symptoms or concerns during these visits.

Who can join the trial?

16 criteria

  • Must have **high grade serous epithelial ovarian cancer**, fallopian tube, or primary peritoneal cancer, confirmed by a pathology report.
  • Must be **18 years or older** at the time of signing the consent form. If local laws require a higher age for adulthood, those laws apply.
  • Must have an **ECOG performance status** of 0 to 1, which means being fully active or having some symptoms but being able to carry out light work.
  • Must have a **life expectancy** of more than 3 months.
  • Must have a **positive FOLR1 expression**, which is a specific test result from a central laboratory.
  • Must have **relapsed platinum-resistant epithelial ovarian cancer** and have received 1 to 3 previous treatments. Specific conditions apply based on the number of treatments and response to them.
  • Must be considered suitable for treatment with certain chemotherapy drugs like **gemcitabine, paclitaxel, topotecan, or PLD** for platinum-resistant disease.
  • Must have had prior treatment with **bevacizumab**, unless there is a documented reason not to use it, such as certain medical conditions.
  • Must have at least one **measurable lesion** on a scan, as defined by specific medical guidelines.
  • Must have **adequate bone marrow function**, which means having enough healthy blood cells. Specific levels for different types of blood cells are required.
  • Must have **adequate liver function**, meaning certain liver enzymes and bilirubin levels must be within specified limits.
  • Must have **adequate kidney function**, with a creatinine clearance of at least 30 mL/min, which measures how well the kidneys are working.
  • Must have a **serum albumin level** of at least 2.5 g/dL, which is a protein in the blood.
  • Must have a **QT interval** on an ECG test that is less than 470 milliseconds, which is a measure of heart rhythm.
  • Must be able to **comply with treatment and testing schedules**.
  • If of childbearing potential, must have a **negative pregnancy test** and agree to use effective birth control or abstain from heterosexual intercourse during treatment and for at least 6 months after the last dose. Women not of childbearing potential include those who have had certain surgeries or are post-menopausal.
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Investigated drugs

  • Luveltamab Tazevibulin (STRO-002)

    is a medication being studied for its effectiveness and safety in treating women with relapsed platinum-resistant epithelial ovarian cancer. This type of cancer can also include cancers of the fallopian tube or primary peritoneal cancers. The medication targets cancer cells that express a specific protein called folate receptor alpha (FOLR1), which is often found in these types of cancers. The goal is to see if this medication can help control the cancer better than standard chemotherapy options.

  • Investigator's Choice Chemotherapy

    refers to the standard chemotherapy treatments that doctors can choose from based on their experience and the specific needs of the patient. These treatments are commonly used to manage ovarian cancer that has not responded well to platinum-based chemotherapy. The study compares the effectiveness of these standard treatments with the new medication, Luveltamab Tazevibulin, to see which works better for patients.

What is already known about the treatment

Luveltamab Tazevibulin – This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating relapsed platinum-resistant epithelial ovarian cancer, including fallopian tube or primary peritoneal cancers. It is in the experimental phase, with ongoing research to determine its safety and efficacy. The main therapeutic indication is for cancers expressing folate receptor alpha (FOLR1). At the molecular level, it works by targeting and binding to the folate receptor alpha, which is often overexpressed in certain cancer cells, potentially inhibiting their growth. It is classified pharmacologically as an antibody-drug conjugate.

Investigated diseases

Advanced Epithelial Ovarian Cancer – This is a type of cancer that begins in the cells on the surface of the ovary. It can also include cancers that originate in the fallopian tubes or the peritoneum, which is the lining of the abdominal cavity. The disease is characterized by the uncontrolled growth of abnormal cells that can spread to other parts of the body. As it progresses, it may cause symptoms such as abdominal bloating, pelvic pain, and changes in bowel habits. The cancer often spreads to nearby tissues and organs, making it more challenging to manage. It is typically diagnosed at an advanced stage due to the subtlety of early symptoms.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-512477-27-00Protocol codeSTRO-002-GM3Estimated enrolment585 patientsSponsorSutro Biopharma Inc.

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