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Study of telisotuzumab adizutecan plus drug combination 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

The study focuses on Colorectal Cancer, a type of cancer that starts in the colon or rectum and can spread to other parts of the body (metastatic). Participants have disease that no longer responds to standard treatments (refractory). The experimental group receives an intravenous (IV) infusion of telisotuzumab adizutecan (code name ABBV-400) together with IV bevacizumab. The comparison group receives the usual care, which includes oral tablets of trifluridine and tipiracil taken by mouth, plus IV bevacizumab. The purpose of the study is to determine whether the new combination can shrink tumors and help patients live longer than the standard therapy.

Participants will receive their assigned medicines on a regular schedule, with IV infusions given at the clinic and oral tablets taken at home. Throughout the study, doctors will perform routine checks, imaging scans, and questionnaires to monitor tumor size, side effects, and overall health. The trial continues until a predefined number of assessments are completed or until a participant stops treatment, after which follow‑up visits assess long‑term outcomes.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Baseline evaluation
After joining the study, you will undergo initial medical examinations, laboratory tests, and imaging studies to record the current status of your colorectal cancer.
The information collected will be used to compare future changes during the trial.
Step 2
Randomization
Based on the study design, you will be assigned to one of two treatment groups.
The assignment is made by the study system and you will not know which group you are in.
Step 3
Start of treatment – test group
If you are placed in the test group, you will receive telisotuzumab adizutecan as an intravenous (iv) infusion.
The listed dose for telisotuzumab adizutecan is 00 mg (as defined in the study protocol).
You will also receive bevacizumab by iv infusion at a dose of 7.5 mg/kg (milligrams per kilogram of body weight).
Step 4
Start of treatment – comparator group
If you are placed in the comparator group, you will take an oral medication that combines trifluridine and tipiracil.
The oral dose is 70 mg/m2 (milligrams per square meter of body‑surface area).
In addition, you will receive bevacizumab by iv infusion at a dose of 7.5 mg/kg.
Step 5
Treatment cycles
Treatment will be given in repeated cycles according to the study schedule.
The exact frequency (for example, weekly or every two weeks) and the total number of cycles are defined by the protocol and will be followed by the study staff.
Step 6
Regular follow‑up visits
During the study you will attend clinic visits at predetermined intervals.
At each visit you will have safety checks, blood tests, and imaging scans to assess the response of your cancer.
Any side effects you experience will be recorded and managed according to the study guidelines.
Step 7
Continuation criteria
Treatment will continue until one of the following occurs: disease progression as shown by imaging, unacceptable toxicity, or completion of the planned treatment period.
The decision to stop treatment will be made by the study investigators based on the collected data.
Step 8
Final assessment and study completion
At the end of the treatment period you will undergo a final set of evaluations, including imaging and laboratory tests.
The results will be used to determine the overall effectiveness and safety of the study therapies.

Who can join the trial?

7 criteria

Have a diagnosis of colorectal cancer.
Be 18 years of age or older (an adult).
Be of any gender (male or female).
Be able to voluntarily sign and date an informed consent form that has been approved by an Ethics Committee (IEC) or Institutional Review Board (IRB) before any study procedures begin.
Have the mental ability to understand the study and give consent, as judged by the investigator.
Be a patient (not a healthy volunteer) who meets the study’s medical criteria.
Have a doctor‑estimated life expectancy of at least 12 weeks.

Who cannot join the trial?

4 criteria

You cannot join if you have previously taken any overall (systemic) cancer treatment that includes a medicine targeting the protein c‑Met—such as special antibodies, antibody‑drug combinations, or drugs that hit two targets at once—or any other experimental drug that has not been approved.
You cannot join if you have had an allergic reaction (also called hypersensitivity) to bevacizumab, to any of its inactive ingredients (excipients), or to medicines similar to trifluridine or tipiracil.
You cannot join if you are allergic to products made from Chinese Hamster Ovary (CHO) cells or to other laboratory‑made antibodies that are designed to act like human proteins (these are called recombinant human or humanized antibodies).
You cannot join if, in the last six months, you have had a drug or alcohol problem that your doctor considers serious (clinically significant).

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Verified sites

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Cliniques Universitaires Saint-Luc
Responsive
Woluwe-Saint-Lambert, Belgium
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Responsive
Madrid, Spain
Grand Hopital De Charleroi
Responsive
Charleroi, Belgium

Trial locations

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Investigated drugs

Telisotuzumab adizutecan
is a laboratory‑made protein (monoclonal antibody) that is given through an IV. It is designed to attach to a specific marker on cancer cells called c‑Met, which helps stop the cells from growing and spreading. In this study it is being tested as a new treatment for people whose colorectal cancer has come back after other therapies.
Bevacizumab
is another laboratory‑made protein given by IV. It works by binding to a substance called VEGF that tumors use to grow new blood vessels. By blocking VEGF, bevacizumab helps starve the tumor of the blood supply it needs to grow. In this trial it is used together with the other drugs to see if the combinations improve outcomes.
Trifluridine and Tipiracil
is an oral chemotherapy pill that contains two ingredients. Trifluridine gets inside cancer cells and interferes with their DNA, making it harder for the cells to divide. Tipiracil helps keep trifluridine active longer by preventing it from being broken down too quickly. This combination is taken by mouth and is a standard option for patients with colorectal cancer that has not responded to other treatments.

What is already known about the treatment

Telisotuzumab adizutecan
This medication is given as an intravenous infusion of a clear solution. It is still being studied in clinical trials (Phase 3) and is not yet approved for general use. It is being investigated for treating metastatic colorectal cancer and works by attaching to the c‑Met protein on cancer cells, blocking signals that tell the cells to grow. It belongs to the class of monoclonal antibody therapies.
Trifluridine and Tipiracil
These drugs are taken together as an oral tablet. They are approved medicines used for patients with refractory metastatic colorectal cancer. Trifluridine is incorporated into the DNA of cancer cells, causing errors that stop the cells from dividing, while tipiracil prevents rapid breakdown of trifluridine, allowing it to work longer. They are classified as antimetabolite chemotherapy agents.
Bevacizumab
This drug is administered by intravenous infusion. It is an approved treatment for several cancers, including metastatic colorectal cancer. Bevacizumab binds to a protein called VEGF, stopping new blood vessels from forming and thereby starving the tumor of nutrients. It is classified as a monoclonal antibody that works as an anti‑angiogenic agent.

Investigated diseases

Colorectal Cancer - Colorectal cancer is a disease in which abnormal cells form a tumor in the colon or rectum, parts of the large intestine. It usually begins as a small growth called a polyp that can become cancer over time. As the tumor grows, it can invade the wall of the colon or rectum and may spread to nearby lymph nodes. If it continues to develop, cancer cells can travel through the bloodstream to other organs such as the liver or lungs. The disease often progresses from a localized stage to more extensive involvement if not removed.