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Study of Avutometinib and Defactinib for Patients with Recurrent Low-Grade Serous 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 a type of ovarian cancer known as Recurrent Low-Grade Serous Ovarian Cancer (LGSOC). The study is testing two treatments: Avutometinib (VS-6766), which is a capsule taken by mouth, and Defactinib (VS-6063), which is a tablet also taken by mouth. Avutometinib works by blocking certain proteins called RAF and MEK, which are involved in cancer cell growth. Defactinib targets a protein called FAK, which helps cancer cells survive and spread.

The purpose of the study is to find the best way to use these treatments, either alone or together, to help patients with LGSOC. The study is divided into different parts. In the first part, researchers will determine whether Avutometinib alone or in combination with Defactinib is more effective. In the following parts, they will further evaluate the effectiveness of the chosen treatment plan. The study will also explore if a lower dose of Avutometinib combined with Defactinib is effective.

Participants in the study will receive either Avutometinib alone or in combination with Defactinib. The study will monitor how well the cancer responds to the treatment and any side effects that may occur. The study aims to provide valuable information on the potential benefits of these treatments for patients with LGSOC.

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

    Initial Treatment Phase

    The study begins with the administration of avutometinib (VS-6766) alone or in combination with defactinib (VS-6063).

    Avutometinib is taken orally in the form of a hard capsule, while defactinib is taken orally as a tablet.

    The goal of this phase is to determine the best treatment regimen for further evaluation.

  2. Step 2

    Evaluation Phase

    The effectiveness of the chosen treatment regimen is assessed.

    This involves monitoring the response of the cancer to the treatment using specific criteria to measure changes in tumor size and progression.

  3. Step 3

    Further Evaluation Phase

    The study continues to evaluate the effectiveness of the treatment regimen identified in the initial phase.

    This phase aims to gather more data on how well the treatment works over a longer period.

  4. Step 4

    Dose Evaluation Phase

    A lower dose of avutometinib in combination with defactinib is evaluated.

    The purpose is to assess the effectiveness and safety of a reduced dosage.

Who can join the trial?

16 criteria

  • Female patients who are 18 years of age or older.
  • Patients must have a confirmed diagnosis of **Recurrent Low-Grade Serous Ovarian Cancer (LGSOC)**, which is a type of ovarian cancer.
  • The tumor must have a known **KRAS mutational status**, which means a specific genetic test has been done on the tumor.
  • The cancer must have progressed or come back after at least one previous treatment for cancer that has spread to other parts of the body.
  • Patients must have **measurable disease**, meaning the cancer can be measured using specific medical criteria.
  • Patients must have an **ECOG performance status** of 0 or 1, which is a scale used to assess how well a patient can perform daily activities.
  • Patients must have adequate organ function, which includes:
    • Good blood health, with specific levels of hemoglobin, platelets, and neutrophils.
    • Good liver function, with specific levels of bilirubin, ALT, and AST.
    • Good kidney function, with a creatinine clearance rate of at least 50 mL/min.
    • Normal blood clotting times, unless on blood thinners.
    • Albumin levels of at least 3.0 g/dL.
    • Normal levels of creatine phosphokinase (CPK).
    • Good heart function, with a left ventricular ejection fraction of at least 50%.
    • The **QTc interval** on an ECG must be less than 460 ms, which is a measure of heart rhythm.
    • Patients must have recovered from any side effects of previous treatments to a mild level, except for hair loss and certain nerve issues.
    • Female patients who can have children must agree to use a highly effective method of birth control during the trial and for one month after the last dose of the study treatment.

Who cannot join the trial?

4 criteria

  • Patients who are not female cannot participate in the study.
  • Patients who do not have Recurrent Low-Grade Serous Ovarian Cancer (LGSOC) cannot participate in the study.
  • Patients who are not within the specified age range cannot participate in the study.
  • Patients who are part of a vulnerable population may not be eligible to participate in the study.
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Investigated drugs

  • Avutometinib

    is a medication being studied for its potential to treat recurrent low-grade serous ovarian cancer. It works by inhibiting certain proteins involved in cell growth, specifically targeting RAF and MEK pathways. This medication is being tested both on its own and in combination with another drug to determine its effectiveness.

  • Defactinib

    is another medication involved in this study. It is known as a FAK inhibitor, which means it targets a protein called FAK that is involved in cancer cell survival and spread. In this trial, defactinib is being used in combination with avutometinib to see if the two drugs together can more effectively treat the cancer compared to using avutometinib alone.

What is already known about the treatment

  • Avutometinib

    Avutometinib is administered orally and is currently being studied in clinical trials for its effectiveness in treating recurrent low-grade serous ovarian cancer. It is a dual RAF/MEK inhibitor, which means it works by blocking specific proteins involved in cell growth and division, potentially slowing down or stopping the growth of cancer cells. Avutometinib is classified as a targeted cancer therapy and is being evaluated both as a standalone treatment and in combination with other medications to determine the most effective regimen.

  • Defactinib

    Defactinib is taken orally and is under investigation in clinical trials for its potential to treat recurrent low-grade serous ovarian cancer. It functions as a FAK inhibitor, targeting focal adhesion kinase, a protein that plays a role in cancer cell survival and spread. By inhibiting this protein, defactinib may help to prevent the progression of cancer. It is classified as a targeted therapy and is being tested in combination with avutometinib to assess its efficacy in enhancing treatment outcomes.

Investigated diseases

Recurrent Low-Grade Serous Ovarian Cancer – This is a type of ovarian cancer characterized by the presence of slow-growing cancer cells in the ovaries. It is known for its tendency to recur after initial treatment, which means the cancer can come back even after it has been treated. The cancer cells in this type are less aggressive compared to high-grade serous ovarian cancer, but they can still spread to other parts of the body over time. The progression of this disease is typically slower, and it may not cause symptoms immediately. As the cancer progresses, it can lead to symptoms such as abdominal pain, bloating, and changes in bowel habits. The disease is often diagnosed at a later stage due to its subtle symptoms.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516986-35-00Protocol codeVS-6766-201Estimated enrolment215 patientsSponsorVerastem Inc.

sourced from the EU Clinical Trials Register and site verification

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