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A Study Comparing Telisotuzumab Adizutecan to Trifluridine, Tipiracil, and Bevacizumab in Adults with Refractory Metastatic Colorectal Cancer

Verified siteRegistered 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 involves people with metastatic colorectal cancer that has not responded to previous treatments. Metastatic colorectal cancer means that cancer that started in the colon or rectum has spread to other parts of the body. The study will test a new treatment called telisotuzumab adizutecan, also known by its code name ABBV-400, which is given through a vein. This treatment will be compared to a combination of two other cancer medicines: LONSURF, which contains trifluridine and tipiracil hydrochloride taken as tablets by mouth, along with bevacizumab given through a vein. The study will only include people whose cancer cells have a certain level of a protein called c-Met on their surface.

The purpose of this study is to find out if telisotuzumab adizutecan works better than the combination of LONSURF and bevacizumab in treating this type of cancer, and to check how safe the new treatment is. The study will be conducted in two stages. In the first stage, researchers will determine the best dose of telisotuzumab adizutecan and see how well it works and what side effects it causes. In the second stage, a larger group of people will be divided randomly into two groups: one group will receive telisotuzumab adizutecan alone, and the other group will receive LONSURF tablets together with bevacizumab. The study will look at whether the cancer shrinks or disappears, how long people live, and what unwanted effects occur with each treatment.

During the study, participants will receive their assigned treatment for up to 64 weeks. Regular check-ups will be done to monitor the cancer and any side effects through physical examinations, blood tests, and imaging scans. The study will also ask participants questions about their quality of life and how they are feeling. Researchers will measure various aspects of how the body processes telisotuzumab adizutecan, including how long it stays in the body and whether the immune system reacts to it. The study will continue to follow participants to see how long they live and how long their cancer stays under control.

The research process

The trial runs in 10 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Assignment to treatment group

    After joining the study, you will be assigned to one of two treatment groups. This assignment will be done randomly, like flipping a coin.

    One group will receive telisotuzumab adizutecan (also called ABBV-400). The other group will receive trifluridine and tipiracil (brand name LONSURF) combined with bevacizumab.

  2. Step 2

    Treatment with telisotuzumab adizutecan

    If you are assigned to the first treatment group, you will receive telisotuzumab adizutecan.

    This medication will be given through a vein (intravenous injection).

    The exact dose, frequency, and duration of treatment will be determined during the study. The study is designed to find the best dose for this medication.

  3. Step 3

    Treatment with trifluridine, tipiracil, and bevacizumab

    If you are assigned to the second treatment group, you will receive two medications: trifluridine and tipiracil (LONSURF) and bevacizumab.

    Trifluridine and tipiracil will be given as tablets that you take by mouth. The tablets come in two strengths: 15 mg/6.14 mg and 20 mg/8.19 mg.

    Bevacizumab will be given through a vein (intravenous infusion).

    The specific dosage, frequency, and duration of treatment will be determined according to the study protocol.

  4. Step 4

    Regular monitoring visits

    Throughout the study, you will have regular visits for monitoring.

    During these visits, your vital signs (such as blood pressure, heart rate, and temperature) will be measured.

    Electrocardiograms (ECGs) will be performed. An ECG is a test that records the electrical activity of your heart.

    Blood and urine samples will be collected for laboratory tests. These tests will check your blood cell counts, organ function, and other health markers.

  5. Step 5

    Disease assessment

    Your cancer will be assessed regularly using imaging scans to see how the disease is responding to treatment.

    These assessments will be done by both the study doctor and an independent group of specialists who do not know which treatment you are receiving.

  6. Step 6

    Quality of life questionnaires

    At certain points during the study, you will be asked to complete questionnaires about your quality of life.

    These questionnaires will ask about your physical functioning, symptoms such as diarrhea, and your overall well-being.

    The questionnaires will be completed at baseline (before treatment starts) and at specific treatment cycles, such as Cycle 5 Day 1 and Cycle 7 Day 1.

  7. Step 7

    Safety monitoring

    Throughout the study, any side effects or health problems you experience will be recorded and monitored.

    The study team will assess whether any changes in your health are potentially related to the study treatment.

  8. Step 8

    Blood tests for medication levels

    If you receive telisotuzumab adizutecan, blood samples will be taken at specific times to measure the levels of the medication in your blood.

    These tests will help determine how your body processes the medication.

  9. Step 9

    Antibody testing

    If you receive telisotuzumab adizutecan, blood samples will be tested to see if your body develops antibodies against the medication.

    Antibodies are proteins your immune system might produce in response to the medication.

  10. Step 10

    Continuation of treatment

    You will continue receiving treatment as long as the treatment is helping control your cancer and you are not experiencing unacceptable side effects.

    The study team will regularly review your condition to determine if you should continue in the study.

Who can join the trial?

5 criteria

  • You must be expected to live for at least 12 weeks as determined by your doctor.
  • You must have an ECOG performance status of 0 or 1, which is a score that measures how well you can carry out daily activities and care for yourself. A score of 0 means you are fully active, and a score of 1 means you can do light work but cannot do strenuous physical activity.
  • You must have measurable disease, which means your cancer can be seen and measured on scans or imaging tests using specific medical guidelines called RECIST version 1.1.
  • You must be an adult to participate in this study.
  • Both men and women can participate in this study.

Who cannot join the trial?

5 criteria

  • The source data does not provide specific exclusion criteria for this clinical trial
  • Exclusion criteria are conditions or factors that would prevent a person from joining the study
  • Without detailed information, it is not possible to list the specific reasons why someone cannot participate in this trial
  • Generally, clinical trials have exclusion criteria to ensure patient safety and to make sure the study results are reliable
  • Common exclusion criteria in cancer trials may include certain other medical conditions, previous treatments, or laboratory test results that fall outside acceptable ranges
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Investigated drugs

  • Telisotuzumab Adizutecan

    is an experimental medication being tested in this trial. It is designed to target and attach to a specific protein called c-Met that is found on cancer cells. Once attached, it delivers a cancer-killing substance directly to the cancer cells to help destroy them. This medication is given on its own as a single treatment.

  • LONSURF

    is an approved cancer medication that contains two active ingredients: trifluridine and tipiracil. It works by interfering with the cancer cells' ability to grow and multiply. Trifluridine stops cancer cells from making new DNA, which they need to grow, while tipiracil helps trifluridine stay active in the body longer. This medication is taken as a pill by mouth.

  • Bevacizumab

    is an approved cancer medication that works by blocking the growth of new blood vessels that tumors need to grow and spread. By cutting off the blood supply to the tumor, it helps slow down or stop cancer growth. In this trial, it is given together with LONSURF.

What is already known about the treatment

  • Telisotuzumab Adizutecan

    This is an experimental cancer medication given through an intravenous infusion (directly into a vein) that is currently being studied in clinical trials for treating advanced colorectal cancer that has spread to other parts of the body and has not responded to other treatments. The drug works by targeting a specific protein called c-Met that is found on the surface of cancer cells, and once attached, it delivers a toxic substance directly into these cells to destroy them while minimizing damage to healthy cells. This medication belongs to a class of drugs called antibody-drug conjugates, which combine the targeting ability of antibodies with the cancer-killing power of chemotherapy agents.

  • LONSURF

    This is an approved oral medication (taken by mouth as tablets) used to treat advanced colorectal cancer that has spread and is no longer responding to standard treatments. The drug contains two active ingredients, trifluridine and tipiracil, which work together by interfering with the cancer cells' ability to make new DNA, essentially preventing them from growing and multiplying. This medication belongs to a class of drugs called antimetabolites, which are commonly used in cancer treatment to slow down or stop tumor growth.

  • Bevacizumab

    This is an established cancer medication administered through an intravenous infusion that is widely used in combination with other treatments for various types of cancer, including colorectal cancer that has spread to other organs. The drug works by blocking a protein called VEGF that cancer cells use to create new blood vessels, effectively cutting off the tumor's blood supply and preventing it from getting the nutrients and oxygen it needs to grow. This medication belongs to a class of drugs called angiogenesis inhibitors, which specifically target the formation of new blood vessels that feed tumors.

Investigated diseases

Metastatic Colorectal Cancer – This is an advanced form of cancer that begins in the colon or rectum and has spread to distant parts of the body. The disease starts when abnormal cells in the lining of the colon or rectum grow uncontrollably and form a tumor. Over time, these cancer cells can break away from the original tumor and travel through the bloodstream or lymphatic system to other organs. Common sites where colorectal cancer spreads include the liver, lungs, and distant lymph nodes. As the disease progresses, the cancer tumors in these new locations continue to grow and can affect the normal function of the affected organs. This condition represents the most advanced stage of colorectal cancer, where the disease has moved beyond the area where it originally started.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512804-20-00Protocol codeM24-064Estimated enrolment400 patientsSponsorAbbVie Deutschland GmbH & Co. KG

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