RecruitingPHASE2INTERVENTIONAL

A Study to Evaluate the Adverse Events, and Efficacy of Intravenous (IV) of Telisotuzumab Adizutecan in Combination With IV Oxaliplatin, Fluorouracil, Folinic Acid/Leucovorin, Bevacizumab, Panitumumab in Adult Participants With Metastatic Colorectal Cancer

This study is for adults with bowel cancer that has spread, also known as metastatic colorectal cancer. Researchers are trying to find out if a new, experimental drug called telisotuzumab adizutecan, when given alongside existing treatments like FOLFOX, bevacizumab or panitumumab, can help. The study wants to check for any side effects and see how well this new combination might work to control the cancer. It starts by finding the right dose for the new drug and then compares different combinations of treatments. This research is important because it could lead to new ways to treat advanced bowel cancer.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

AbbVie

Enrolment target

390

Start

24 Apr 2025

Estimated completion

01 Apr 2028

Metastatic Colorectal Cancer

What is this study about?

This study is about finding better ways to treat bowel cancer that has spread to other parts of the body, which doctors call metastatic colorectal cancer. While there are treatments available, researchers are always looking for new options to help patients.

The main goal of this particular study is to test a new medicine called telisotuzumab adizutecan. This isn't a standard treatment yet; it's still being investigated. Doctors want to see how safe it is and how well it works when given together with treatments already used for bowel cancer, such as FOLFOX (a combination of drugs like oxaliplatin, fluorouracil, and leucovorin) along with either bevacizumab or panitumumab. They will carefully watch for any side effects and measure if the cancer activity changes.

First, a small group of participants will receive increasing doses of telisotuzumab adizutecan with the standard treatments to find the safest and most effective amount to give. Once this dose is found, participants will be put into different groups. Some will get the new drug combination, and others will get the standard treatment without the new drug. This helps the researchers compare the different treatments fairly and see if adding telisotuzumab adizutecan makes a positive difference.

Key takeaways

This study is for advanced bowel cancer.
It tests a new drug combined with existing treatments.
The aim is to find a safe and effective new option.
Participation involves regular hospital visits, tests, and monitoring.
You might receive the new drug or standard treatment.
You can leave the study at any time.

Who may be eligible?

This study is looking for adults aged 18 or older who have metastatic colorectal cancer. To join, your general health needs to be good enough to take part in a study like this, which doctors check using a scoring system. You also need to have cancer that can be measured by scans, so doctors can clearly see if the treatment is working.

There are certain reasons why someone might not be able to join. For example, if you've already had a treatment that targets a specific pathway in cancer called 'c-Met', or certain types of chemotherapy drugs (like those in the 'topoisomerase inhibitor' group) then you might not be eligible. This is because these previous treatments could affect how the new drug works or make it harder to tell if the new drug is effective.

Also, if you've had other types of cancer in the last five years that could potentially spread or be life-threatening (not including very minor skin cancers, for example), you would not be able to join this study. These rules help make sure the study is as safe as possible and that the results are clear.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have bowel cancer that has spread?
Are you generally well enough for a clinical study (ECOG 0 or 1)?
Have you NOT had certain specific previous cancer treatments (like c-Met targeting drugs or some topoisomerase inhibitors)?
Have you NOT had other serious cancers in the last five years?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have regular visits to a hospital or clinic. These visits will involve various medical checks, including blood tests and questionnaires, to monitor your health and how the treatment is affecting you. You will receive the study treatments, which are given into a vein (intravenously), as part of your visits.

Initially, new participants will help doctors find the best dose of the new drug, then later participants will be assigned to one of three treatment groups. Everyone will be closely monitored for side effects. You might have more appointments and assessments than if you were receiving standard care. The study is expected to last for about six years in total, though your personal participation duration might vary based on your treatment response and doctor’s advice.

Potential risks and benefits

Taking part in any clinical study has potential benefits and risks. You might benefit from receiving a new treatment that isn't widely available yet, which could help your condition, but there's no guarantee it will work for you. There's also a chance you could experience side effects from the new drug or the combination of treatments, some of which might be serious. The research team will carefully monitor you for any problems. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (54)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

City of Hope National Medical Center /ID# 270255
Verified postcode
Duarte, United States· Recruiting
UCLA - Santa Monica /ID# 270621
Verified postcode
Santa Monica, United States· Recruiting
Yale New Haven Hospital /ID# 270565
Verified postcode
New Haven, United States· Recruiting
University of Chicago Medical Center /ID# 271688
Verified postcode
Chicago, United States· Recruiting
Hope And Healing Cancer Services /ID# 271562
Verified postcode
Hinsdale, United States· Recruiting
Dana-Farber Cancer Institute /ID# 270624
Verified postcode
Boston, United States· Recruiting
Saint Lukes Hospital of Kansas City /ID# 270633
Verified postcode
Kansas City, United States· Recruiting
Nebraska Cancer Specialists - Omaha - Wright Street /ID# 271646
Verified postcode
Omaha, United States· Recruiting
University of North Carolina Medical Center /ID# 267786
Verified postcode
Chapel Hill, United States· Recruiting
Oncology Hematology Care - Eastgate /ID# 271493
Verified postcode
Cincinnati, United States· Recruiting
Texas Oncology - Austin Midtown /ID# 271354
Verified postcode
Austin, United States· Recruiting
Texas Oncology - Deke Slayton Cancer Center /ID# 271355
Verified postcode
Webster, United States· Recruiting

Common questions

What is metastatic colorectal cancer?

It's bowel cancer that has spread from where it started to other parts of your body.

What is telisotuzumab adizutecan?

It's an experimental drug, meaning it's still being tested and is not yet a standard treatment.

Will I definitely get the new drug?

Not necessarily. After an initial phase to find the right dose, participants will be put into different groups, and some will receive the standard treatment without the new drug for comparison.

How long will I be in the study if I join?

The study runs for roughly six years in total, but your involvement will depend on your individual treatment plan and progress.

What kind of extra checks will I have?

You'll have regular hospital visits for medical assessments, blood tests, and questionnaires to monitor your health and treatment effects.

How to find out more

ABBVIE CALL CENTER

abbvieclinicaltrials@abbvie.com 844-663-3742 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.