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Study of Zolbetuximab and CAPOX 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 known as gastric cancer, specifically in cases where the cancer is advanced and cannot be surgically removed or has spread to other parts of the body. The study is looking at a treatment that combines a new drug called zolbetuximab with two chemotherapy drugs, capecitabine and oxaliplatin, which together are referred to as CAPOX. The trial will compare this combination to a placebo plus CAPOX to see which is more effective as a first treatment option for patients with this type of cancer.

The main goal of the study is to evaluate how well the treatment works in stopping the cancer from getting worse. Participants will receive the treatment through an intravenous infusion, which means the medication is given directly into a vein. The study will take place over a period of time, and participants will be monitored regularly to assess their health and the progression of the cancer. The trial will also look at the safety of the treatment and any side effects that may occur.

Participants in the study will be adults with a specific type of gastric cancer that is HER2-negative and expresses a protein called Claudin 18.2. The study aims to provide valuable information on whether the addition of zolbetuximab to the standard chemotherapy regimen can improve outcomes for patients with this challenging form of cancer. The trial is expected to continue until 2025, with the hope of finding a more effective treatment option for those affected by this disease.

The research process

The trial runs in 4 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 along with CAPOX (a combination of capecitabine and oxaliplatin), while the other group will receive a placebo with CAPOX.

    The purpose of this study is to evaluate the effectiveness of zolbetuximab in combination with CAPOX compared to a placebo with CAPOX in treating certain types of stomach cancer.

  2. Step 2

    Treatment administration

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

    The specific dosage and frequency of administration will be determined by the study protocol and the healthcare team overseeing the trial.

  3. Step 3

    Monitoring and assessments

    Throughout the study, the patient's health and response to the treatment will be closely monitored. This includes regular medical assessments, blood tests, and imaging studies to evaluate the progression of the disease.

    The primary goal is to measure progression-free survival, which is the time during and after the treatment that the patient lives with the disease without it getting worse.

  4. Step 4

    Completion of treatment

    The study is expected to continue until March 31, 2025. The duration of participation for each patient may vary based on individual response to the treatment and other factors.

    After completing the treatment phase, follow-up visits may be scheduled to monitor long-term health outcomes and gather additional data for the study.

Who can join the trial?

17 criteria

  • The patient must provide written consent to participate in the study, which is approved by an ethics committee.
  • The patient must be an adult, which means they are 18 years or older.
  • The patient must have a confirmed diagnosis of gastric or gastroesophageal junction (GEJ) adenocarcinoma, which is a type of cancer in the stomach or where the stomach meets the esophagus.
  • The patient's cancer must be advanced and cannot be removed by surgery, or it has spread to other parts of the body.
  • The patient must have a tumor that can be seen on medical imaging tests.
  • The patient's tumor must show a specific protein called **CLDN18.2** in at least 75% of the cancer cells.
  • The patient's tumor must not have a protein called **HER2**.
  • The patient must be in good physical condition, able to carry out daily activities, as measured by a scale called **ECOG performance status** of 0 or 1.
  • The patient must be expected to live for at least 12 more weeks according to the doctor's opinion.
  • The patient must have certain levels of blood cells and proteins within a specific range, as determined by recent lab tests.
  • Female patients must not be pregnant and must agree to use birth control during the study and for a period after the study ends.
  • Female patients must agree not to breastfeed during the study and for a period after the study ends.
  • Female patients must agree not to donate eggs during the study and for a period after the study ends.
  • Male patients with female partners who can become pregnant must agree to use birth control during the study and for a period after the study ends.
  • Male patients must agree not to donate sperm during the study and for a period after the study ends.
  • Male patients with pregnant or breastfeeding partners must agree to use a condom or abstain from sex during the study and for a period after the study ends.
  • The patient must agree not to participate in another study while taking part in this one.

Who cannot join the trial?

8 criteria

  • Patients who have a different type of cancer than the one being studied.
  • Patients who have a positive test for HER2, which is a protein that can affect the growth of cancer cells.
  • Patients who have had previous treatment for their cancer that is not allowed in the study.
  • Patients who have other serious health conditions that could interfere with the study treatment.
  • Patients who are pregnant or breastfeeding.
  • Patients who are unable to follow the study procedures or attend study visits.
  • Patients who have allergies to the study drugs or their ingredients.
  • Patients who are participating in another clinical trial at the same time.
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Investigated drugs

  • Zolbetuximab

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

  • Capecitabine

    is a chemotherapy medication used to treat various types of cancer, including stomach cancer. It works by interfering with the DNA of cancer cells, preventing them from growing and dividing. Capecitabine is often used in combination with other cancer treatments to enhance its effectiveness.

  • Oxaliplatin

    is another chemotherapy drug that is used to treat cancer. It works by damaging the DNA in cancer cells, which can stop them from multiplying and spreading. Oxaliplatin is typically used in combination with other chemotherapy medications to improve treatment outcomes.

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 and gastroesophageal cancers. It is specifically being tested for its effectiveness in treating Claudin 18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. The medication works by targeting the Claudin 18.2 protein, which is found on the surface of some cancer cells, helping the immune system to recognize and attack these cells. Zolbetuximab is classified as a monoclonal antibody, a type of targeted cancer therapy.

Investigated diseases

  • Gastric Adenocarcinoma

    This is a type of cancer that begins in the glandular cells of the stomach lining. It often progresses slowly and may not show symptoms in the early stages. As it advances, it can cause symptoms like stomach pain, nausea, and weight loss. The disease can spread to nearby organs and lymph nodes. It is classified as locally advanced when it cannot be surgically removed or metastatic when it has spread to other parts of the body. Gastric adenocarcinoma is often associated with specific genetic markers, such as Claudin 18.2 positivity and HER2 negativity.

  • Gastroesophageal Junction Adenocarcinoma

    This cancer occurs where the esophagus meets the stomach, known as the gastroesophageal junction. It shares similarities with gastric adenocarcinoma in terms of progression and symptoms. The disease may lead to difficulty swallowing, chest pain, and unintended weight loss. It is considered locally advanced when it cannot be surgically removed or metastatic when it has spread beyond the original site. This type of adenocarcinoma is also characterized by specific genetic markers, including Claudin 18.2 positivity and HER2 negativity. The progression of the disease can vary based on these genetic factors.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511648-16-00Protocol code8951-CL-0302Estimated enrolment507 patientsSponsorAstellas Pharma Global Development Inc.

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