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Study on ABBV-400, Fluorouracil, Leucovorin, and Budigalimab for Advanced or Metastatic Stomach and Esophageal Cancer Patients

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What is this study about?

This clinical trial is focused on studying the treatment of advanced forms of certain types of cancer, specifically gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. These are cancers that affect the stomach and the area where the stomach meets the esophagus. The study will explore the use of a new treatment combination as a first-line therapy, meaning it is the first treatment given for these conditions. The treatment being tested includes a combination of several medications: ABBV-400, Fluorouracil (also known as 5-FU), Leucovorin (also known as folinic acid), and Budigalimab. ABBV-400 is an experimental drug, while Fluorouracil and Leucovorin are commonly used in cancer treatment. Budigalimab is a type of protein-based medication.

The purpose of the study is to evaluate the safety and effectiveness of this combination treatment. Participants will receive these medications through an intravenous injection, which means the drugs are delivered directly into the bloodstream through a vein. The study will compare this new combination to a standard treatment known as FOLFOX, which includes Oxaliplatin, Fluorouracil, and Leucovorin, along with Budigalimab. The trial aims to determine if the new combination can improve outcomes for patients, such as slowing the progression of the disease or increasing survival time.

Participants in the study will receive treatment over a period of up to nine months. During this time, they will be closely monitored by healthcare professionals to assess how well the treatment is working and to check for any side effects. The study will help researchers understand if the new combination of drugs can be a better option for treating these types of cancer compared to existing treatments. This research is important for developing more effective therapies for patients with advanced gastric, gastroesophageal junction, or esophageal adenocarcinoma.

1 beginning of treatment

Upon joining the clinical trial, the first step involves receiving the initial dose of the study medications. This includes a combination of drugs administered through an intravenous injection. The medications are oxaliplatin, ABBV-400, budigalimab, fluorouracil, and folinic acid.

The administration of these medications is done in a controlled environment, typically at a medical facility, where healthcare professionals can monitor the process and ensure safety.

2 ongoing treatment

The treatment involves regular administration of the study drugs. The frequency and dosage are determined by the healthcare team based on the specific protocol of the trial.

Regular visits to the medical facility are required for the administration of the intravenous injections and for monitoring your health and response to the treatment.

3 monitoring and assessments

Throughout the trial, regular assessments are conducted to monitor the progress of the treatment. This includes physical examinations, blood tests, and imaging studies to evaluate the response of the cancer to the treatment.

These assessments help in determining the effectiveness of the treatment and in making any necessary adjustments to the medication regimen.

4 end of treatment

The treatment phase continues until the end of the trial period or until it is determined that the treatment is no longer beneficial.

At the conclusion of the trial, a final assessment is conducted to evaluate the overall outcomes and any long-term effects of the treatment.

Who Can Join the Study?

  • You or your legally authorized representative must sign and date a consent form before any study procedures begin.
  • If you have a history of hepatitis B or C, specific tests and treatments are required to participate.
  • If you are HIV positive, your CD4 count must be at least 100 cells/µL, and you must be on effective antiretroviral therapy with a low viral load.
  • You must provide a sample of your tumor tissue. If not available, a new biopsy may be needed.
  • You must have advanced or metastatic adenocarcinoma of the stomach, gastroesophageal junction, or esophagus that cannot be surgically removed.
  • Your cancer must be HER2 negative, which means it does not have a certain protein that can affect cancer growth.
  • For Stage 2 of the study, your PD-L1 status must be known or tested before randomization.
  • You must not have received prior systemic therapy for advanced or metastatic cancer, except for certain treatments completed at least 6 months ago.
  • You must have measurable disease according to specific criteria, even if previously treated with radiation.
  • You must be willing and able to follow the study procedures.
  • You must be at least 18 years old or older, depending on local regulations.
  • Your performance status must be 0 or 1, indicating you are fully active or have some restrictions but can still perform light work.
  • Your laboratory test results must meet specific criteria, including liver and kidney function, blood cell counts, and protein levels.
  • Your heart’s electrical activity (QTc) must be below a certain level, and you should not have significant heart problems.
  • Your heart’s pumping ability (ejection fraction) must be at least 50%, with no significant heart issues.
  • You must not have a history of certain heart diseases, recent heart attacks, or unstable heart conditions.
  • Any side effects from previous treatments must be resolved to a mild level before starting the study, except for hair loss.

Who Cannot Join the Study?

  • Patients with any other type of cancer besides adenocarcinoma of the gastroesophageal junction cannot participate. This is a type of cancer that occurs where the stomach meets the esophagus.
  • Patients who have received treatment for their cancer before cannot participate. This means if you have already been treated for your cancer, you are not eligible.
  • Patients with serious heart problems cannot participate. This includes conditions like heart failure or recent heart attacks.
  • Patients with uncontrolled high blood pressure cannot participate. This means if your blood pressure is not well-managed with medication, you are not eligible.
  • Patients with active infections cannot participate. This means if you have an ongoing infection that requires treatment, you are not eligible.
  • Patients with known allergies to the study drugs cannot participate. This means if you are allergic to any of the medications used in the study, you are not eligible.
  • Patients who are pregnant or breastfeeding cannot participate. This is to ensure the safety of the mother and child.
  • Patients with a history of drug or alcohol abuse cannot participate. This means if you have had problems with substance abuse in the past, you are not eligible.
  • Patients with certain autoimmune diseases cannot participate. These are conditions where the immune system attacks the body, like lupus or rheumatoid arthritis.
  • Patients who are unable to follow the study procedures cannot participate. This means if you cannot comply with the study requirements, you are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario De Navarra Pamplona Spain
Universitaet Leipzig Leipzig Germany
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

Site Name City Country Status
Krankenhaus Nordwest GmbH Frankfurt Germany
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Centre hospitalier universitaire de Liege Liege Belgium
Algemeen Ziekenhuis Klina Brasschaat Belgium
Hospital General Universitario Gregorio Maranon Madrid Spain
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Instituto de Investigacion Sanitaria Fundacion para la Investigacion del Hospital Clinico de Valencia-INCLIVA Valencia Spain
Hämatologisch-Onkologische Praxis Eppendorf (hope) Hamburg Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
01.04.2025
Germany Germany
Not recruiting
01.04.2025
Spain Spain
Recruiting
01.04.2025

Trial locations

Investigated drugs:

ABBV-400 is an experimental medication being tested in this clinical trial. It is designed to target and attack cancer cells specifically, which may help in treating advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma. The goal of using ABBV-400 is to see if it can be safely combined with other treatments and improve patient outcomes.

Fluorouracil, often called 5-FU, is a type of chemotherapy used to treat various cancers. It works by interfering with the cancer cells’ ability to grow and divide, which can help slow down or stop the progression of the disease.

Leucovorin is a medication that is often used alongside chemotherapy drugs like fluorouracil. It helps enhance the effectiveness of the chemotherapy, making it more potent against cancer cells. Leucovorin can also help reduce some of the side effects associated with chemotherapy.

Budigalimab is another experimental medication included in this trial. It is an antibody that is designed to help the immune system recognize and attack cancer cells more effectively. By boosting the body’s natural defenses, budigalimab may improve the overall effectiveness of the cancer treatment regimen.

Investigated diseases:

Adenocarcinoma of the gastroesophageal junction – This disease is a type of cancer that occurs where the esophagus meets the stomach. It begins in the glandular cells that line the gastroesophageal junction. As the disease progresses, these cancerous cells can grow and form a tumor. The tumor may invade nearby tissues and organs, potentially causing symptoms like difficulty swallowing or chest pain. Over time, the cancer can spread to other parts of the body through the lymphatic system or bloodstream. The progression of the disease can vary, with some cases advancing more rapidly than others.

Trial ID:
2024-513008-32-00
Protocol code:
M24-977
Trial Phase:
Therapeutic exploratory (Phase II)

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