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

Verified siteRegistered drugNo placebo
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What is this trial about?

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

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.

The research process

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

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

17 criteria

  • 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 trial?

7 criteria

  • 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.
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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.

What is already known about the treatment

Zolbetuximab – Zolbetuximab is administered intravenously and is currently being studied in clinical trials as a potential treatment for certain types of stomach cancer. It is being evaluated for its effectiveness in treating metastatic gastric or gastroesophageal junction adenocarcinoma, particularly in patients who are positive for Claudin 18.2 and negative for HER2. The medication works by targeting and binding to the Claudin 18.2 protein, which is often overexpressed in these cancer cells, thereby helping the immune system to recognize and destroy the cancer cells. Zolbetuximab is classified as a monoclonal antibody, a type of targeted cancer therapy.

Investigated diseases

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511365-11-00Protocol code8951-CL-0301Estimated enrolment566 patientsSponsorAstellas Pharma Global Development Inc.

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