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Study Comparing XL092 and Atezolizumab with Regorafenib for Patients with 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 treatments for metastatic colorectal cancer, which is a type of cancer that starts in the colon or rectum and spreads to other parts of the body. The study will compare the effectiveness of a new treatment combination of XL092 and atezolizumab against an existing medication called regorafenib. XL092 is a chemical compound that works by inhibiting certain proteins involved in cancer cell growth, while atezolizumab is a type of immunotherapy that helps the immune system recognize and attack cancer cells. Regorafenib is a medication already used to treat this type of cancer.

The purpose of the study is to evaluate the overall survival of patients receiving the combination of XL092 and atezolizumab compared to those receiving regorafenib. Participants in the study will be randomly assigned to receive either the new combination treatment or the existing medication. The study will be conducted over a period of approximately 73 weeks, during which participants will receive their assigned treatment and be monitored for their response to the therapy. Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of the treatments being studied.

Throughout the study, participants will undergo regular check-ups and tests to monitor their health and the progression of their cancer. The study aims to provide valuable information on the effectiveness and safety of the new treatment combination, potentially offering new hope for patients with metastatic colorectal cancer. Participants will be closely monitored by healthcare professionals to ensure their safety and well-being during the trial.

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 verifying a diagnosis of metastatic colorectal cancer and ensuring previous treatments have been completed or are no longer effective.

    A review of medical history and current health status is performed. This includes checking organ and marrow function and ensuring recovery from any previous treatment side effects.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two treatment groups. One group receives a combination of XL092 and atezolizumab, while the other group receives regorafenib.

  3. Step 3

    Treatment administration

    For those receiving XL092 and atezolizumab:

    - XL092 is administered orally in tablet form. The specific dosage and frequency are determined by the study protocol.

    - Atezolizumab is given as an intravenous infusion. The dosage is 1,200 mg, and the frequency is determined by the study protocol.

    For those receiving regorafenib:

    - Regorafenib is administered orally in the form of film-coated tablets. The dosage is 40 mg, and the frequency is determined by the study protocol.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to assess the effectiveness of the treatment and to check for any side effects. This includes physical examinations, blood tests, and imaging studies.

    Participants are required to report any side effects or changes in health status to the study team.

  5. Step 5

    End of treatment

    The treatment continues until the study's end date or until it is determined that the treatment is no longer beneficial.

    A final assessment is conducted to evaluate the overall health status and any long-term effects of the treatment.

Who can join the trial?

11 criteria

  • Patients must have a confirmed diagnosis of adenocarcinoma, which is a type of cancer, in the colon or rectum.
  • If patients or their partners can have children, they must agree to use very effective birth control methods during the study and for a certain time after the last treatment.
  • Women who can have children must not be pregnant when the study starts. They are considered able to have children unless they have had permanent procedures like removal of the uterus or ovaries, or if they are confirmed to be in menopause, which is when they haven't had a period for 12 months and are over 45 years old.
  • Patients must have received certain standard cancer treatments for metastatic colorectal cancer and have shown that these treatments no longer work for them or they cannot tolerate them. Previous experimental treatments are allowed.
  • Patients must have a measurable disease according to specific criteria used by doctors to assess tumors.
  • Patients must provide a sample of their tumor tissue. If old samples are not available, they must provide a new sample before starting the study.
  • Patients must have recovered from any side effects of previous treatments to a certain level, unless these side effects are not significant or are stable with treatment.
  • Patients must be 18 years or older.
  • Patients must have a performance status of 0-1, which means they are fully active or have some symptoms but can still do light work.
  • Patients must have adequate organ and bone marrow function, which will be checked with lab tests before starting the study.
  • Patients must be able to understand and follow the study requirements and must have signed a consent form agreeing to participate.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of cancer than the one being studied.
  • Patients who have not progressed during, after, or are intolerant to standard treatments.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to follow the study procedures or attend the required visits.
  • Patients who have other serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who are participating in another clinical trial at the same time.
  • Patients who have had a recent major surgery or are planning to have surgery during the study.
  • Patients who have a history of allergic reactions to the study medications.
  • Patients who have certain infections that could affect the study results.
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Investigated drugs

  • XL092

    is an investigational medication being studied for its potential to treat metastatic colorectal cancer. It is being tested in combination with another medication to see if it can help improve survival rates in patients who have not responded well to standard treatments.

  • Atezolizumab

    is a type of immunotherapy known as a checkpoint inhibitor. It works by helping the immune system recognize and attack cancer cells more effectively. In this trial, it is used in combination with XL092 to see if the two together can provide better outcomes for patients with metastatic colorectal cancer.

  • Regorafenib

    is a medication that is already approved for use in certain types of cancer, including metastatic colorectal cancer. It works by blocking proteins that promote cancer cell growth and survival. In this study, it is being used as a comparison to evaluate the effectiveness of the combination of XL092 and atezolizumab.

What is already known about the treatment

  • XL092

    This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating metastatic colorectal cancer. It is not yet widely recognized in medical literature as it is still under investigation. The main therapeutic indication is for patients with metastatic colorectal cancer who have not responded to standard treatments. XL092 works by inhibiting certain proteins that promote cancer cell growth and survival. It is classified as a tyrosine kinase inhibitor.

  • Atezolizumab

    This medication is given through intravenous infusion and is approved for use in various cancers, including metastatic colorectal cancer. It is well-documented in medical literature and is used to help the immune system attack cancer cells. The main therapeutic indication is for patients with metastatic colorectal cancer, often in combination with other drugs. Atezolizumab works by blocking a protein that prevents the immune system from attacking cancer cells. It is classified as an immune checkpoint inhibitor.

  • Regorafenib

    This medication is taken orally and is approved for use in treating metastatic colorectal cancer. It is well-established in medical literature and is used when other treatments have failed. The main therapeutic indication is for patients with metastatic colorectal cancer who have progressed after standard therapies. Regorafenib works by blocking multiple enzymes that promote cancer growth. It is classified as a multikinase inhibitor.

Investigated diseases

Metastatic Colorectal Cancer – This is a type of cancer that begins in the colon or rectum and has spread to other parts of the body. It often progresses through stages, starting in the lining of the colon or rectum and potentially moving to nearby lymph nodes and distant organs, such as the liver or lungs. The disease may cause symptoms like changes in bowel habits, abdominal pain, and weight loss. As it advances, it can lead to more severe symptoms depending on the organs affected. The spread of cancer cells occurs through the bloodstream or lymphatic system. The progression can vary greatly among individuals, influenced by factors like the cancer's genetic makeup and the patient's overall health.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512915-33-00Protocol codeXL092-303Estimated enrolment944 patientsSponsorExelixis Inc.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).