Study of Zolbetuximab Alone and with Drug Combination for Patients with Advanced Stomach or Gastroesophageal Junction Cancer

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What is this study about?

This clinical trial is focused on studying treatments for advanced cancer of the stomach or the gastroesophageal junction. The study is investigating the effects of a medication called zolbetuximab, also known by its code name IMAB362. Zolbetuximab is being tested both as a standalone treatment and in combination with other therapies, including chemotherapy and immunotherapy. The chemotherapy drugs involved in the study include fluorouracil, oxaliplatin, and folinic acid. Additionally, the study will explore the use of nivolumab, marketed as Opdivo, which is an immunotherapy drug.

The purpose of the study is to determine how well zolbetuximab works in treating this type of cancer. Participants in the study will receive treatments through an intravenous infusion, which means the medication is given directly into a vein. The study will monitor the response of the cancer to the treatment, as well as the safety and tolerability of the drugs. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the actual drugs being tested.

The study will take place over a period of time, during which participants will receive regular treatments and undergo assessments to track their progress. The goal is to gather information on how effective zolbetuximab is, both on its own and in combination with other treatments, in improving outcomes for patients with advanced stomach or gastroesophageal junction cancer. The study will also look at the side effects and overall impact on the quality of life for those participating.

1 initial treatment phase

The study begins with the administration of zolbetuximab as a single agent. This medication is given through an intravenous infusion, which means it is delivered directly into the bloodstream through a vein.

The objective of this phase is to evaluate the response of the cancer to zolbetuximab alone.

2 combination therapy phase

Following the initial phase, zolbetuximab is combined with other treatments. These may include chemotherapy agents such as fluorouracil, oxaliplatin, and folinic acid, as well as the immunotherapy drug nivolumab.

Each of these medications is administered via intravenous infusion. The specific combination and schedule depend on the cohort to which the patient is assigned.

3 monitoring and assessment

Throughout the trial, regular assessments are conducted to monitor the patient’s response to the treatment. This includes imaging tests to evaluate the size and spread of the cancer.

Blood tests and other evaluations are performed to check for side effects and to ensure the patient’s safety.

4 follow-up phase

After completing the treatment regimen, patients enter a follow-up phase. This involves periodic check-ups to monitor for any signs of cancer recurrence and to assess long-term health outcomes.

The follow-up period is designed to gather data on the effectiveness and safety of the treatment over time.

Who Can Join the Study?

You must have advanced cancer of the stomach or the area where the stomach meets the esophagus.
You need to provide written consent to participate, which means you agree to join the study after understanding all the details.
Your cancer must be confirmed by a scan to be advanced, cannot be removed by surgery, or has spread to other parts of the body within 28 days before starting the study treatment.
Your tumor must show a specific protein called CLDN18.2, which will be checked by a special test.
You agree not to join another study while you are receiving treatment in this study.
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.
Your doctor must believe you are likely to live for at least 12 more weeks.
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 tests.
You must be considered an adult according to local laws when you sign the consent form.
If you are a woman, you must not be pregnant and agree to use birth control if you can have children. You must also agree not to breastfeed or donate eggs during the study and for a certain time after.
If you are a man, you must agree to use birth control if your partner can have children and not donate sperm during the study and for a certain time after.
If you are a man with a pregnant or breastfeeding partner, you must agree to avoid sexual activity or use a condom during the study and for a certain time after.
Your cancer must be confirmed by a test to be a type called gastric or GEJ adenocarcinoma.

Who Cannot Join the Study?

Patients who do not have advanced cancer of the stomach or the gastroesophageal junction cannot participate. This means the study is only for those with a specific type of cancer that affects the stomach or the area where the stomach meets the esophagus.
Patients who are not within the specified age range cannot participate. The study is for certain age groups, so if you are too young or too old, you may not be eligible.
Patients who are not part of the specified clinical trial groups cannot participate. This means the study is looking for people with certain characteristics or conditions.
Patients who are not female or male cannot participate. The study is open to both men and women.
Patients who are not considered part of a vulnerable population cannot participate. A vulnerable population includes people who might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli	Naples	Italy
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Universita’ Di Pisa	Pisa	Italy
Hopital Beaujon	Clichy	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	03.09.2018
Italy	Not recruiting	03.09.2018

Trial locations

Investigated drugs:

Zolbetuximab is being studied as a treatment for certain types of stomach cancer, specifically gastric or gastroesophageal junction adenocarcinoma. This medication is being tested both on its own and in combination with other treatments like chemotherapy and immunotherapy. The goal is to see how well it works in shrinking or controlling the cancer in patients whose tumors have a specific protein called Claudin 18.2.

Investigated diseases:

Adenocarcinoma gastric

Advanced cancer of the stomach or the gastroesophageal junction – This disease involves the uncontrolled growth of abnormal cells in the stomach or the area where the stomach meets the esophagus. As the cancer progresses, it can invade nearby tissues and spread to other parts of the body. Symptoms may include difficulty swallowing, weight loss, and stomach pain. The disease can lead to complications such as bleeding or obstruction in the digestive tract. It is often diagnosed at an advanced stage due to the subtlety of early symptoms. The progression of the disease can vary, with some cases advancing more rapidly than others.

Trial ID:

2024-511649-21-00

Protocol code:

8951-CL-0103

NCT ID:

NCT03505320

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Zolbetuximab Alone and with Drug Combination for Patients with Advanced Stomach or Gastroesophageal Junction Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?