Study on ABBV-400 with Fluorouracil, Folinic Acid, and Bevacizumab for Adults with Unresectable Metastatic Colorectal Cancer

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What is this study about?

This clinical trial is focused on studying a type of cancer called unresectable metastatic colorectal cancer. This is a condition where cancer that started in the colon or rectum has spread to other parts of the body and cannot be removed with surgery. The study is testing a new treatment combination to see how safe and effective it is for people who have already received other treatments for this cancer.

The treatment being tested includes a new drug called ABBV-400, which is an antibody-drug conjugate. This means it is a special type of medicine that combines an antibody with a drug to target cancer cells more precisely. ABBV-400 is given together with three other medications: Fluorouracil, Folinic Acid, and Bevacizumab. These medications are already used in cancer treatment and are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

The purpose of the study is to find the best dose of ABBV-400 when used with the other medications and to evaluate how well this combination works in treating the cancer. Participants in the study will receive these treatments over a period of up to 36 weeks. Some participants may receive a placebo instead of ABBV-400 to help researchers compare the effects. The study will monitor participants for any side effects and changes in their cancer to determine the safety and effectiveness of the treatment.

1 joining the study

Upon joining the study, participation begins with an initial assessment to confirm eligibility. This includes a diagnosis of unresectable metastatic colorectal cancer and measurable disease according to specific criteria.

2 treatment initiation

The treatment phase involves receiving a combination of medications through intravenous infusion. These medications include fluorouracil, irinotecan, bevacizumab, folinic acid, and ABBV-400.

The specific dosage and frequency of administration are determined by the study protocol, aiming to find the optimal dose of ABBV-400 in combination with the other drugs.

3 monitoring and assessments

Throughout the study, regular monitoring and assessments are conducted to evaluate the response to treatment. This includes measuring disease activity and checking for any adverse effects.

The primary focus is on objective response and progression-free survival, as assessed by the investigator.

4 ongoing evaluation

Secondary evaluations include the duration of response, overall survival, and best overall response. These assessments help determine the effectiveness and safety of the treatment regimen.

5 completion of study

The study is estimated to conclude by October 2026. At the end of the study, final assessments are made to determine the overall outcomes and any long-term effects of the treatment.

Who Can Join the Study?

Must have a diagnosis of unresectable metastatic colorectal cancer. This means the cancer has spread to other parts of the body and cannot be removed by surgery.
Must have a measurable disease according to specific guidelines called RECIST v1.1. This means the cancer can be measured in size using medical imaging.
Must be within the age range of adults, typically 18 years and older.
Both male and female participants are eligible.
Participants from vulnerable populations, such as those who may need special protection, are also eligible.

Who Cannot Join the Study?

Patients who have a different type of cancer other than colorectal cancer cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are not able to safely receive the study medications cannot participate.
Patients who have certain medical conditions that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who are unable to follow the study procedures cannot participate.
Patients who have participated in another clinical trial recently may not be eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Technische Universitaet Dresden	Dresden	Germany
Hospital Universitario Hm Sanchinarro	Madrid	Spain
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Institut Jules Bordet	Anderlecht	Belgium
Universitair Ziekenhuis Gent	Gent	Belgium
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Algemeen Ziekenhuis Delta	Roeselare	Belgium
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Cxujsyite Uwlxtddrawnnwn Szhzreeqt	Woluwe-Saint-Lambert	Belgium
Usmyljbzym Mdfboay Ccebra Hkvedheokctlyaiwk	Hamburg	Germany
Invnrn	Bonheiden	Belgium
Umwutyfnft Oy Amcklhg	Edegem	Belgium
Hffmlmhi Vvbh dpoetarr	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	01.10.2024
Germany	Not recruiting	01.10.2024
Spain	Not recruiting	01.10.2024

Trial locations

Investigated drugs:

ABBV-400 is an investigational medication being studied for its potential to treat colorectal cancer that cannot be surgically removed and has spread to other parts of the body. The trial aims to find the best dose of ABBV-400 when used in combination with other cancer treatments.

Fluorouracil is a chemotherapy medication used to treat various types of cancer, including colorectal cancer. It works by interfering with the growth and spread of cancer cells in the body.

Folinic Acid is often used in combination with other chemotherapy drugs to enhance their effectiveness. It helps protect healthy cells from the harmful effects of chemotherapy and supports the action of fluorouracil.

Bevacizumab is a medication that targets and inhibits a protein called vascular endothelial growth factor (VEGF). By blocking VEGF, bevacizumab helps prevent the growth of new blood vessels that tumors need to grow and spread. It is used in combination with other cancer treatments to improve their effectiveness.

Investigated diseases:

Colorectal Cancer – Colorectal cancer is a type of cancer that begins in the colon or rectum, parts of the large intestine. It typically starts as small, noncancerous clumps of cells called polyps that form on the inside of the colon or rectum. Over time, some of these polyps can become cancerous. As the cancer progresses, it can invade and destroy normal tissue nearby and may spread to other parts of the body. The progression of colorectal cancer can vary, with some cases growing slowly over several years. Early stages may not show symptoms, but as it advances, symptoms like changes in bowel habits, blood in the stool, and abdominal discomfort may occur.

Trial ID:

2023-505110-14-00

Protocol code:

M24-311

NCT ID:

NCT06107413

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on ABBV-400 with Fluorouracil, Folinic Acid, and Bevacizumab for Adults with Unresectable Metastatic Colorectal Cancer

What is this study about?

Who Can Join the Study?

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