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Study on the Effectiveness of Ompenaclid with FOLFIRI and Bevacizumab for Patients with Advanced or Metastatic Colorectal 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 cancer known as advanced or metastatic colorectal cancer, which is a serious condition where cancer has spread beyond the colon or rectum to other parts of the body. The study is particularly interested in cases where the cancer has a specific genetic change called a RAS mutation. The purpose of the study is to compare the effectiveness of a new treatment called ompenaclid with a placebo, when used in combination with a standard chemotherapy regimen known as FOLFIRI (which includes the drugs folinic acid, fluorouracil, and irinotecan) and another drug called bevacizumab.

Participants in the study will receive either the new treatment or a placebo, along with FOLFIRI and bevacizumab. The study will monitor how well the cancer responds to the treatment, as well as any side effects that may occur. The treatment is administered through an intravenous infusion, which means it is given directly into a vein. The study aims to find out if ompenaclid can improve outcomes for patients with this type of cancer compared to the current standard treatment options.

The trial will take place over a period of time, during which participants will have regular check-ups and assessments to track their progress. These assessments will include physical exams, laboratory tests, and imaging studies to evaluate the cancer's response to the treatment. The study is designed to provide valuable information that could lead to new treatment options for patients with advanced or metastatic colorectal cancer, particularly those with RAS mutations.

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, you will be required to provide signed informed consent. This is a document that confirms your understanding of the study and your willingness to participate.

    You will need to undergo a series of initial tests to confirm your eligibility. These tests include a pregnancy test for women of childbearing potential, and various blood tests to assess your organ function and overall health.

  2. Step 2

    Treatment initiation

    The treatment phase begins with the administration of a combination of medications. These include folinic acid, fluorouracil, bevacizumab, and irinotecan, all of which are given through an intravenous (IV) line.

    You will also receive either ompenaclid or a placebo in the form of oral tablets. The specific dosage and frequency of these medications will be determined by the study protocol and your healthcare team.

  3. Step 3

    Ongoing treatment

    Throughout the study, you will continue to receive the combination of IV medications and oral tablets. The duration of this treatment will be specified by the study protocol.

    Regular visits to the study site will be necessary to monitor your response to the treatment and to manage any side effects. These visits will include physical examinations, blood tests, and imaging studies.

  4. Step 4

    Follow-up assessments

    After completing the treatment phase, follow-up assessments will be conducted to evaluate your overall response to the treatment.

    These assessments will include imaging studies to measure the size of your tumors, as well as blood tests and other evaluations to monitor your health.

  5. Step 5

    End of study

    At the end of the study, a final evaluation will be conducted to assess your overall health and the effectiveness of the treatment.

    You will be provided with information about any further treatment options and follow-up care that may be necessary.

Who can join the trial?

13 criteria

  • The cancer must be advanced, meaning it has spread to other parts of the body or is too large to be removed by surgery, and cannot be treated with more radiation or local therapies.
  • Women who can have children must have a negative pregnancy test within 2 weeks before starting treatment.
  • Both men and women who can have children must agree to use reliable birth control methods while in the study and for a certain period after the study ends.
  • You must sign a consent form agreeing to participate in the study before any study-related procedures or treatments begin.
  • You must be able to attend all study visits and follow the study requirements, including follow-up checks.
  • The cancer must have worsened after receiving only one previous standard treatment for advanced colorectal cancer, which included a drug called oxaliplatin. If you have a specific type of colorectal cancer with certain genetic features, you must have also received treatment with specific drugs approved by health authorities.
  • The cancer must be confirmed as a type called adenocarcinoma or poorly differentiated, and it must have a specific genetic change called RAS mutation. This can be confirmed by a blood test if a tumor sample is not available.
  • The cancer must be measurable by standard imaging techniques, and if you had radiation therapy before, the measurable cancer must be outside the area that was treated unless it has worsened in that area.
  • You must be at least 18 years old.
  • You must have a good general health status, as indicated by an ECOG performance score of 0 or 1, which means you are fully active or have some symptoms but can carry out light work.
  • Your organs must be functioning well, as shown by specific blood test results, including kidney function, liver function, and blood cell counts.
  • If you are not taking blood thinners like warfarin, your blood clotting tests must be within normal limits. If you are taking such medication, your dose must be stable, and your blood test results must be within a safe range.
  • Your heart must be functioning well, with a left ventricular ejection fraction (LVEF) of at least 45%, as determined by heart imaging tests.

Who cannot join the trial?

4 criteria

  • Patients with **metastatic colorectal cancer** that is resistant to current treatments cannot participate. This means the cancer has spread to other parts of the body and does not respond to existing therapies.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are not part of the specified clinical trial groups cannot participate. The study is designed for specific groups of patients.
  • Patients who are part of a **vulnerable population** cannot participate. This refers to groups of people who may be at a higher risk of harm or exploitation.
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Investigated drugs

  • Omepnaclid

    is a new medication being tested in this clinical trial. It is being studied to see if it can help treat advanced or metastatic colorectal cancer that has a specific genetic mutation known as RAS. The trial is looking at how well this medication works when used together with other cancer treatments.

  • FOLFIRI

    is a combination of chemotherapy drugs used to treat colorectal cancer. It includes three different medications that work together to stop cancer cells from growing and dividing. This combination is often used when the cancer has spread to other parts of the body.

  • Bevacizumab

    is a medication that helps stop the growth of new blood vessels that tumors need to grow. By blocking these blood vessels, bevacizumab can help slow down or stop the growth of cancer. It is used in combination with other cancer treatments to improve their effectiveness.

What is already known about the treatment

Ompenaclid – Ompenaclid is administered orally and is currently being studied in clinical trials for its potential use in treating metastatic colorectal cancer, particularly in cases resistant to existing treatments. This medication is being explored for its ability to target specific cancer subtypes, such as those with RAS mutations, which are known to be challenging to treat. At the molecular level, ompenaclid works by interfering with cancer cell growth and survival pathways, although the exact mechanism is still under investigation. It is classified as an investigational drug, meaning it is not yet approved for general medical use but is being tested for its safety and effectiveness in clinical settings.

Investigated diseases

Metastatic Colorectal Cancer – Metastatic colorectal cancer is a type of cancer that originates in the colon or rectum and has spread to other parts of the body. It typically progresses through stages, starting from the inner lining of the colon or rectum and potentially moving to nearby lymph nodes and distant organs such as the liver or lungs. The disease often begins with the formation of polyps, which can become cancerous over time. As the cancer advances, it can invade deeper layers of the colon or rectum and spread through the bloodstream or lymphatic system. The progression of metastatic colorectal cancer can vary, with some cases spreading rapidly while others may progress more slowly. The presence of specific genetic mutations, such as RAS mutations, can influence the behavior and progression of the disease.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-503356-27-00Protocol codeRGX-202-002Estimated enrolment86 patientsSponsorInspirna Inc.

sourced from the EU Clinical Trials Register and site verification

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