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

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What is this study about?

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.

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 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 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 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 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 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 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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hospital Universitario De Salamanca	Salamanca	Spain
Hospital Clinico San Carlos	Madrid	Spain
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Hospital Universitario De Navarra	Pamplona	Spain
Technische Universitaet Dresden	Dresden	Germany
Frisius	Heerenveen	The Netherlands
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
University Hospital Maastricht	Maastricht	The Netherlands

Other Sites

Site Name	City	Country
Krankenhaus Nordwest GmbH	Frankfurt	Germany
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Klinikum Chemnitz gGmbH	Chemnitz	Germany
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Casa Sollievo Della Sofferenza	San Giovanni Rotondo	Italy
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Hospital Del Mar	Barcelona	Spain
ARNAS Garibaldi Di Catania	Catania	Italy
Virgen del Rocío University Hospital	Sevilla	Spain
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Stichting Radboud University Medical Center	Nijmegen	The Netherlands
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie	Cracow	Poland
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Hopital Beaujon	Clichy	France
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Azienda Ospedaliero Universitaria Pisana	Pisa	Italy
Haematologisch Onkologische Praxis Eppendorf / Norddeutsches Studienzentrum für Innovative Onkologie	Hamburg	Germany
Unka Crbhwjia Tmmxri Sxl z ozot	Lodz	Poland
Alpyxagyh Udj	Amsterdam	The Netherlands
Ayybeet Ujj Iybsd Dz Rgvzwh Etkkln	Reggio Emilia	Italy
Uzyigozqdxzfle Ceujinu Kolghndnm	Gdansk	Poland
Hwpdwxfl Unoebhrazasox Mpvgqrt Da Vutfcseavf	Santander	Spain
Rlvrqkmyrz Sghpazy Szjaoqmygxbkbhw Iyx Dab Wzfdsagvkg Bcniqyzfluit	Grudziadz	Poland
Eswsjts Uxvqyfwhrhml Mpcsayp Czlomkh Rkmtslygs (ppcsbgk Meu	Rotterdam	The Netherlands
Cgeh Dw Nmhvx	Vandoeuvre Les Nancy	France
Nehgnydi Itiorhcg Ouwvjizaz Iym Mbbxl Sfahexsurrtudzhwrcbocfvzsfjg Igtgbsnq Bucmadqs	Cracow	Poland
Iwxclvfu dn Cgvlcxltzfbb Hdmzlfqwxna Uwlbvhhcidlht dt Srxlu Ejqtfsy (bzhdpih	Saint Priest En Jarez	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	30.06.2026
Germany	Not recruiting	30.06.2026
Italy	Not recruiting	30.06.2026
Poland	Not recruiting	30.06.2026
Spain	Not recruiting	30.06.2026
The Netherlands	Not recruiting	30.06.2026

Trial locations

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.

Investigated diseases:

Colorectal cancer metastatic

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 ID:

2024-512804-20-00

Protocol code:

M24-064

NCT ID:

NCT06614192

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?