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Study of Telisotuzumab Adizutecan for Adults with Colorectal Cancer Who Have Positive Circulating Tumor DNA After Treatment but No Visible Cancer on Scans

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical study is investigating the effectiveness of telisotuzumab adizutecan (ABBV-400) in treating colorectal cancer. Specifically, it focuses on patients who have completed adjuvant chemotherapy (treatment given after surgery), have no visible signs of cancer on imaging tests (No Radiographic Evidence of Disease), but still have circulating tumor DNA (ctDNA) in their bloodstream, which may indicate microscopic disease that could lead to cancer recurrence.

The purpose of this study is to evaluate how effective telisotuzumab adizutecan is when used alone compared to standard care treatments in preventing cancer from returning. Participants in the study will have previously undergone surgery for their colorectal cancer and received at least 3 months of platinum-based chemotherapy. They must have detectable tumor DNA in their blood after completing their initial treatment, despite having no visible cancer on CT scans.

During the study, some participants will receive telisotuzumab adizutecan alone, while others will receive current standard treatments. The medication will be administered through intravenous infusion (delivered directly into a vein). The study will track how long participants remain free of disease and monitor changes in circulating tumor DNA levels in their blood over time.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Confirmation of Eligibility
After joining the study, your eligibility will be confirmed based on having colorectal cancer (cancer of the colon or rectum) with no visible signs of disease on CT scans.
You must have completed at least 3 months of platinum-based chemotherapy as part of your adjuvant treatment (treatment given after surgery).
A blood test will confirm the presence of circulating tumor DNA (ctDNA) in your blood, which are tiny fragments of DNA from cancer cells that can be detected even when no tumor is visible on scans.
Step 2
Treatment Assignment
You will be randomly assigned to receive either telisotuzumab adizutecan alone or the current standard of care treatment.
The assignment process is random, similar to flipping a coin, and you cannot choose which treatment you will receive.
Step 3
Treatment Administration
If assigned to the telisotuzumab adizutecan group, you will receive this medication through an intravenous (IV) infusion, which means it will be administered directly into your vein.
The treatment will be given in cycles, with each cycle representing a specific time period for receiving the medication.
You must begin treatment within 6 weeks after your ctDNA positive result is confirmed.
Step 4
Monitoring and Follow-up
Throughout the study, you will undergo regular CT scans of your chest, abdomen, and pelvis to check for any signs of cancer returning.
Blood samples will be collected to monitor ctDNA levels in your blood, with special attention to whether these levels decrease or disappear by the 6-month mark.
Your doctor will monitor you for any side effects or adverse reactions to the treatment.
Step 5
Study Duration
The study will continue until September 2029, but your individual participation may vary depending on how you respond to treatment and whether your cancer returns.
The main goal is to measure how long you remain free of disease (disease-free survival) and your overall survival time.
The effectiveness of the treatment will be assessed by tracking whether your ctDNA levels clear from your blood and whether the cancer returns.

Who can join the trial?

7 criteria

You must have adenocarcinoma of the colon or rectum (a type of colorectal cancer) confirmed by tissue or cell examination.
Your surgical tumor material must be available for submission for Signatera™ personalized panel (a test that analyzes tumor DNA) and assessment of c-Met protein levels (a protein that may be involved in cancer growth).
You must have received at least 3 months of platinum-based doublet adjuvant chemotherapy (a combination of two chemotherapy drugs including a platinum drug given after surgery).
You cannot have been treated with topoisomerase inhibitors (a specific type of chemotherapy drug) as part of your adjuvant therapy.
You must have no evidence of disease on chest, abdominal, and pelvic CT scans within 6 weeks before starting the study treatment.
Your blood test must be positive for circulating tumor DNA (ctDNA) (cancer DNA found in your bloodstream) after completing adjuvant therapy.
You must begin treatment within 6 weeks after your ctDNA positive result is confirmed.

Who cannot join the trial?

9 criteria

You cannot participate if you have already received more than 8 weeks of treatment with a specific cancer drug after surgery for your colon or rectal cancer.
You cannot join if you have previously been treated with any drug that targets the c-Met protein (a protein that can affect cancer growth).
If you have active or untreated cancer that has spread to the brain or spinal cord, you cannot participate.
You cannot take part if you have serious heart conditions, including heart attack in the last 6 months, heart failure, or irregular heart rhythms that require medication.
If you have inflammatory bowel disease (chronic inflammation of your digestive tract, such as Crohn's disease or ulcerative colitis), you are not eligible.
You cannot participate if you have any other medical condition that the study doctor believes would make the study unsafe for you.
You cannot join if you have had major surgery within 28 days before starting the study treatment.
If you are pregnant, breastfeeding, or planning to become pregnant during the study period, you cannot participate.
You cannot take part if you have a known allergy or sensitivity to the study drug or any of its components.

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Verified sites

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Responsive
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
Responsive
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Belgium
Responsive
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, Spain

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Investigated drugs

Telisotuzumab Adizutecan (ABBV-400)
is an antibody-drug conjugate being studied for treatment of colorectal cancer. It targets specific cancer cells and delivers a cancer-fighting drug directly to those cells. In this study, it's being tested in patients who have completed their initial treatment for colorectal cancer and have circulating tumor DNA in their blood but no visible cancer on scans.
Standard of Care
refers to the current best treatment approaches typically used for patients with colorectal cancer after their initial treatment. This serves as the comparison group to determine if telisotuzumab adizutecan offers any advantages over existing treatments.

What is already known about the treatment

Telisotuzumab Adizutecan (ABBV-400) - This is an antibody-drug conjugate administered via intravenous infusion that targets cancer cells expressing the c-Met receptor. Currently under investigation in clinical trials, telisotuzumab adizutecan shows promise for treating colorectal cancer patients who have completed their initial treatment but still have circulating tumor DNA in their blood. It works by delivering a cytotoxic payload directly to cancer cells through a targeted antibody that binds to c-Met proteins on the cancer cell surface, causing cell death while minimizing damage to healthy tissues. Telisotuzumab adizutecan belongs to the pharmacological class of targeted cancer therapies known as antibody-drug conjugates.

Investigated diseases

Colorectal Cancer – A malignant tumor that develops in the tissues of the colon or rectum. It typically begins as small, noncancerous growths called polyps that form on the inner lining of the colon or rectum and can develop into cancer over time. Colorectal cancer often progresses slowly and may not cause symptoms in early stages. As it advances, symptoms may include changes in bowel habits, rectal bleeding, persistent abdominal discomfort, and unexplained weight loss. The cancer can grow through the wall of the colon or rectum and potentially spread to nearby lymph nodes and distant organs if left untreated.