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Study on the Safety and Effectiveness of Telisotuzumab Adizutecan and Drug Combination 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 has spread from the colon or rectum to other parts of the body. The study will explore the safety and effectiveness of different treatment combinations that include a new medication called telisotuzumab adizutecan. This medication will be tested alongside other drugs such as ABBV-400, bevacizumab, folinic acid, panitumumab, oxaliplatin, and fluorouracil. These drugs are administered through an intravenous infusion, which means they are given directly into a vein.

The purpose of the study is to evaluate how well these combinations work compared to standard treatments for metastatic colorectal cancer. The study will also assess the safety and tolerability of these combinations, which means checking for any side effects and how well patients can handle the treatment. Additionally, the study aims to find the best dose of telisotuzumab adizutecan to use in future studies. Participants in the study will receive one of the treatment combinations, and some may receive a placebo. The study will last for a period of up to 13 weeks, during which participants will be closely monitored by healthcare professionals.

Throughout the study, researchers will look at various outcomes, such as how long patients live without the cancer getting worse, how long any positive response to the treatment lasts, and overall survival rates. The study will help determine if these new treatment combinations can offer better outcomes for patients with metastatic colorectal cancer. The results will contribute to understanding the potential benefits and risks of these treatments, ultimately aiming to improve care for individuals with this type of cancer.

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

    Joining the study

    Upon joining the study, you will be informed about the purpose and procedures involved. This study aims to evaluate the safety and effectiveness of different treatment combinations for metastatic colorectal cancer.

    You will be assigned to one of the treatment groups, which may include a combination of medications administered through an intravenous (IV) infusion.

  2. Step 2

    Treatment administration

    You will receive medications such as bevacizumab, folinic acid, panitumumab, oxaliplatin, abbv-400, and fluorouracil. These medications are given as a solution for infusion, meaning they are delivered directly into your bloodstream through a vein.

    The frequency and dosage of these medications will be determined by the study protocol and your specific treatment group. The duration of administration will also be specified by the study team.

  3. Step 3

    Monitoring and assessments

    Throughout the study, your health and response to the treatment will be closely monitored. This includes regular check-ups and assessments to evaluate the effectiveness of the treatment and any side effects you may experience.

    You will undergo various tests and scans to measure the progress of your condition and to ensure your safety during the trial.

  4. Step 4

    End of treatment

    At the end of the treatment period, you will have a final assessment to determine the overall response to the treatment.

    The study team will discuss the results with you and provide guidance on the next steps for your care.

Who can join the trial?

8 criteria

  • Participants must have **Metastatic Colorectal Cancer (mCRC)**, which means the cancer has spread from the colon or rectum to other parts of the body.
  • Participants must have a **performance status** of 0 or 1 according to the **Eastern Cooperative Oncology Group (ECOG)** scale. This means they should be fully active or have some symptoms but can carry out light work.
  • Participants must have a **QTc** (a measure of heart rhythm) of less than 470 milliseconds, no severe heart rhythm problems, and no other significant heart issues.
  • Participants must have **histologically or cytologically confirmed mCRC**, meaning the cancer diagnosis is confirmed by examining tissue or cells under a microscope.
  • Participants must have **measurable disease** according to **RECIST v1.1**, which is a standard way to measure how well a cancer treatment works by looking at changes in tumor size.
  • For Substudy 2, participants must have a **left-sided primary tumor**, meaning the original tumor is located on the left side of the colon or rectum.
  • Participants can be of any gender.
  • Participants must be within the age range of adults and older adults.

Who cannot join the trial?

10 criteria

  • Patients with other types of cancer besides Metastatic Colorectal Cancer cannot participate.
  • Patients who have had a different cancer treatment recently may not be eligible.
  • Patients with severe or uncontrolled medical conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding are not allowed to join the study.
  • Patients who have participated in another clinical trial within a certain time frame may be excluded.
  • Patients with known allergies to the study medication or its components cannot participate.
  • Patients who are unable to comply with the study procedures and follow-up visits.
  • Patients with a history of certain heart conditions may be excluded.
  • Patients with active infections that require treatment may not be eligible.
  • Patients with a history of drug or alcohol abuse that could interfere with the study.
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Investigated drugs

Telisotuzumab Adizutecan is a medication being studied for its potential to treat metastatic colorectal cancer. It is part of a group of treatments that aim to target and attack cancer cells specifically, which may help to slow down or stop the growth of the cancer. This medication is being tested in combination with other treatments to see if it can improve outcomes for patients with this type of cancer. The study is also looking at how safe and tolerable this medication is for patients, as well as finding the best dose to use in future studies.

What is already known about the treatment

Telisotuzumab Adizutecan – This medication is administered as part of a combination treatment for metastatic colorectal cancer, typically given through an intravenous infusion. It is currently being studied in clinical trials to assess its safety and effectiveness compared to standard treatments for this type of cancer. The main therapeutic use of Telisotuzumab Adizutecan is to treat metastatic colorectal cancer, which is cancer that has spread beyond the colon or rectum. At the molecular level, it works by targeting specific proteins on cancer cells, helping to stop their growth and spread. It falls under the pharmacological classification of targeted cancer therapies, which are designed to specifically attack cancer cells while minimizing damage to normal cells.

Investigated diseases

Metastatic Colorectal Cancer – Metastatic colorectal cancer is a type of cancer that originates in the colon or rectum and spreads to other parts of the body, such as the liver, lungs, or distant lymph nodes. The disease begins when abnormal cells in the colon or rectum grow uncontrollably, forming a tumor. As the cancer progresses, these cells can invade nearby tissues and enter the bloodstream or lymphatic system, allowing them to travel to distant sites. The spread of cancer to other organs is known as metastasis, which can complicate the disease and affect various bodily functions. Symptoms may include changes in bowel habits, blood in the stool, abdominal pain, and unexplained weight loss. The progression of metastatic colorectal cancer can vary, with some patients experiencing rapid spread while others may have a slower disease course.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-512981-33-00Protocol codeM24-533Estimated enrolment224 patientsSponsorAbbVie Deutschland GmbH & Co. KG

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