Study on Zolbetuximab and mFOLFOX6 for Patients with Advanced Gastric or Gastroesophageal Junction Cancer

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What is this study about?

This clinical trial is focused on studying a type of cancer called gastric or gastroesophageal junction adenocarcinoma, which is a cancer that starts in the stomach or the area where the stomach meets the esophagus. The study is specifically looking at cases where the cancer is advanced and cannot be removed by surgery or has spread to other parts of the body. The trial is testing a new treatment that combines a drug called zolbetuximab (also known as IMAB362) with a standard chemotherapy regimen called mFOLFOX6. This combination is being compared to a placebo plus mFOLFOX6 to see if it is more effective as a first treatment option for patients with this type of cancer.

The purpose of the study is to evaluate how well the combination of zolbetuximab and mFOLFOX6 works in stopping the cancer from getting worse. Participants in the study will receive the treatment through an intravenous infusion, which means the medication is given directly into a vein. The study will follow participants over a period of time to monitor the progression of the cancer and any side effects of the treatment. The trial is designed to be double-blind, meaning neither the participants nor the researchers know who is receiving the zolbetuximab combination or the placebo, to ensure unbiased results.

Throughout the study, researchers will collect data on how long participants live without the cancer getting worse, as well as overall survival rates and quality of life. They will also monitor the safety and tolerability of the treatment by checking for any adverse effects. The study aims to provide valuable information on whether zolbetuximab can be an effective addition to the current treatment options for patients with advanced gastric or gastroesophageal junction adenocarcinoma.

1 joining the study

Upon joining the study, the patient will be randomly assigned to one of two groups. One group will receive the medication zolbetuximab in combination with a chemotherapy regimen called mFOLFOX6. The other group will receive a placebo with the same chemotherapy regimen.

The study is designed to be double-blind, meaning neither the patient nor the healthcare providers will know which group the patient is in.

2 treatment administration

The treatment involves the administration of zolbetuximab or placebo through an intravenous infusion. This means the medication is delivered directly into the bloodstream through a vein.

The chemotherapy regimen mFOLFOX6 includes several drugs: oxaliplatin, leucovorin, and fluorouracil. These are also administered intravenously.

3 treatment schedule

The treatment is given in cycles. Each cycle lasts two weeks. The patient will receive the infusion on the first day of each cycle.

The duration of the treatment will depend on the patient’s response and the progression of the disease.

4 monitoring and assessments

Throughout the study, the patient’s health and response to the treatment will be closely monitored. This includes regular medical examinations, blood tests, and imaging studies to assess the size and spread of the cancer.

The primary goal is to evaluate the time until the disease progresses or the patient experiences any adverse effects.

5 end of treatment

The treatment will continue until the disease progresses, the patient experiences unacceptable side effects, or the study reaches its conclusion.

After the treatment ends, follow-up visits will be scheduled to monitor the patient’s health and gather additional data.

Who Can Join the Study?

You must give written permission to join the study, following the rules of your country.
You must have a confirmed diagnosis of Gastric or Gastroesophageal Junction (GEJ) adenocarcinoma. This means cancer in the stomach or the area where the stomach meets the esophagus.
Your cancer must be confirmed as locally advanced unresectable or metastatic. This means the cancer has spread and cannot be removed by surgery.
Your cancer must be visible on scans, either as measurable or non-measurable disease, according to specific guidelines.
Your tumor must show a specific protein called CLDN18.2 in at least 75% of the cancer cells.
Your tumor must be HER2-negative, which is a specific characteristic of the cancer.
You must have an ECOG performance status of 0 to 1, which means you are fully active or have some symptoms but can still do light work.
You must have a life expectancy of about 12 weeks, as estimated by the doctor.
You must meet certain blood test requirements, such as having enough red blood cells, white blood cells, and platelets, and normal levels of liver and kidney function.
You must be an adult, which means you are at least 18 years old.
You must agree not to join another study while participating in this one.
If you are a woman, you must not be pregnant and agree to use birth control during the study and for a period after the study ends.
If you are a woman, you must agree not to breastfeed during the study and for a period after the study ends.
If you are a woman, you must agree not to donate eggs during the study and for a period after the study ends.
If you are a man with a partner who can become pregnant, you must agree to use birth control during the study and for a period after the study ends.
If you are a man, you must agree not to donate sperm during the study and for a period after the study ends.
If you are a man with a pregnant or breastfeeding partner, you must agree to use a condom or abstain from sex during the study and for a period after the study ends.

Who Cannot Join the Study?

Patients who have a different type of cancer than the one being studied cannot participate.
Patients who have received certain treatments for their cancer before may not be eligible.
Patients with serious health conditions that could interfere with the study may be excluded.
Patients who are pregnant or breastfeeding cannot take part in the study.
Patients who are unable to follow the study procedures or attend required visits may not be eligible.
Patients with allergies to the study medications or similar drugs may be excluded.
Patients who are participating in another clinical trial at the same time 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	Status
Centr Georges Francois Leclerc	Dijon	France
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Hopital Saint Antoine	Paris	France
Centre Antoine Lacassagne	Nice	France
Institut Jules Bordet	Anderlecht	Belgium
Hospital Del Mar	Barcelona	Spain
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli	Lublin	Poland
Azienda Unita Locale Socio Sanitaria N 8 Berica	Vicenza	Italy
University Clinical Hospital Virgen De La Arrixaca	Murcia	Spain
Centre De Lutte Contre Le Cancer Eugene Marquis	Rennes	France
Ihgfxscp Rwxrfacz Du Cznqlr Dt Mlnrjmervop	Montpellier	France
Ilxhblhw Cuunas Dbtnofzoqndoqkshi	L'hospitalet De Llobregat	Spain
Hgofbkqu Vgya dpjdyxjd	Barcelona	Spain
Swqcihccittiiflmhqu Bzh Uc (qntevbqxqlpcviczjbfo	Halle (Saale)	Germany

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	24.09.2018
France	Not recruiting	24.09.2018
Germany	Not recruiting	24.09.2018
Italy	Not recruiting	24.09.2018
Poland	Not recruiting	24.09.2018
Spain	Not recruiting	24.09.2018

Trial locations

Investigated drugs:

Zolbetuximab (IMAB362) is an investigational medication being studied for its potential to treat certain types of stomach cancer. It is designed to target and bind to a specific protein called Claudin 18.2, which is found on the surface of some cancer cells. By attaching to this protein, zolbetuximab may help the immune system recognize and attack the cancer cells.

mFOLFOX6 is a combination chemotherapy regimen used to treat various types of cancer, including gastric cancer. It includes several medications that work together to stop the growth of cancer cells. The components of mFOLFOX6 are designed to interfere with the DNA of cancer cells, preventing them from dividing and growing. This regimen is often used as a first-line treatment for advanced cancers.

Investigated diseases:

Adenocarcinoma gastric

Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma – This is a type of cancer that begins in the glandular cells lining the stomach or the area where the stomach meets the esophagus. It is characterized by the spread of cancer cells beyond the original site to other parts of the body, which is referred to as metastasis. The disease often progresses as the cancer cells invade nearby tissues and organs, leading to a range of symptoms such as difficulty swallowing, weight loss, and abdominal pain. As the cancer advances, it may affect the function of the stomach and esophagus, causing further complications. The progression of the disease can vary, with some individuals experiencing rapid advancement while others may have a slower progression.

Trial ID:

2024-511365-11-00

Protocol code:

8951-CL-0301

NCT ID:

NCT03504397

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Zolbetuximab and mFOLFOX6 for Patients with Advanced Gastric or Gastroesophageal Junction Cancer

What is this study about?

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