Study summary

Zolbetuximab is being studied as a treatment for people with cancer in and around the stomach or cancer where the food pipe (esophagus) joins the stomach (gastroesophageal junction cancer). Most people with this type of cancer have a protein called Claudin 18.2 in their tumor. Zolbetuximab is thought to work by attaching to Claudin 18.2 in their tumor. This switches on the body’s immune system to attack the tumor.

There is an unmet medical need to treat people with advanced cancer in and around the stomach or gastroesophageal junction cancer. This study will provide more information on zolbetuximab given by itself and in combination with other treatments in adults with advanced stomach or gastroesophageal junction cancer. The study is currently ongoing globally. People in this study will either be treated with zolbetuximab by itself, with zolbetuximab and chemotherapy, with zolbetuximab and a medicine called pembrolizumab, or zolbetuximab with chemotherapy and a medicine called nivolumab.

This study is ongoing, but enrollment in any of the treatment options has been completed. In addition, at this stage of the study, treatment in some of these treatment options has completed.

The main aim of this study is to check how well zolbetuximab controls tumors when given by itself.

Adults with cancer in and around the stomach or gastroesophageal junction cancer can take part. Their cancer is locally advanced unresectable or metastatic and has the CLDN18.2 marker in a tumor sample. Locally advanced means the cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by surgery.

Metastatic means the cancer has spread to other parts of the body. They may have been previously treated with standard therapies. People cannot take part if they need to take medicines to suppress their immune system, have blockages or bleeding in their gut, have specific uncontrollable cancers such as symptomatic or untreated cancers in the nervous system, have a specific heart condition or infections.

There are different treatments in the study. People who take part will receive just 1 of the treatments.

Treatment will be given in cycles. The treatment is given through a vein; this is called an infusion. Some people with advanced disease will have 1 infusion in 3 week (21-day) cycles. Some people will have several infusions in 6 week (42-day) cycles. Some people with cancer in and around the stomach or gastroesophageal junction who have surgery for their cancer will have a few infusions in 2-week (14-day) cycles. This will happen before and after they have surgery for their cancer.

People may receive chemotherapy for up to 6 months. Some people enrolled to received zolbetuximab and pembrolizumab, may have received pembrolizumab for up to 2 years.

People will visit the clinic on certain days during their treatment; there may be extra visits during the first cycle of treatment. The study doctors will check if people had any medical problems from zolbetuximab and the other study treatments. Also, people in the study will have a health check including blood tests. On some visits they will also have scans to check for any changes in their cancer. Tumor samples will be taken at certain visits with the option of giving a tumor sample after treatment has finished.

People will visit the clinic after they stop treatment. They will be asked about any medical problems and will have a health check including blood tests. After the clinic visits end some people will have a telephone health check every 3 months. The number of visits and checks done at each visit will depend on the health of each person and whether they completed their treatment or not.

Additional Study Details

Phase
Phase 2
Product
  • zolbetuximab
  • oxaliplatin
  • leucovorin
  • fluorouracil
  • Pembrolizumab
  • folinic acid
  • nivolumab
  • Docetaxel
  • Type
    Interventional
    Masking
    Double (Participant, Investigator)
    Enrollment number
    143
    Show Additional Study Details

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    Would you like more information about clinical trial sites that are recruiting participants for A study of zolbetuximab (IMAB362) in adults with gastric cancer? Contact us by filling out your information to the right and we’ll respond to you.

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    • Armenia
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    • Austria
    • Belarus
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    • Bosnia And Herzegovina
    • Brazil
    • Bulgaria
    • Canada
    • Chile
    • China
    • Colombia
    • Croatia
    • Czech Republic
    • Denmark
    • Dominican Republic
    • Egypt
    • Estonia
    • Finland
    • Former Serbia and Montenegro
    • France
    • Georgia
    • Germany
    • Greece
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    • India
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    • Slovakia
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    • South Africa
    • Spain
    • Sweden
    • Switzerland
    • Taiwan, Province of China
    • Thailand
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    • Ukraine
    • United Kingdom
    • United States
    • Vietnam

    By clicking ["Continue/Submit"], you agree that Astellas may contact you by email with information to help you connect with clinical trial sites. While we can connect you to clinical trial sites, we cannot answer questions about any investigational therapy through email. Your consent to receiving emails is not a requirement to participate in a clinical trial or study. For more information, including how to unsubscribe at any time, see our Privacy Notice & Cookies Policy.

      Locations

      Contact Us
      Contact Us
      Active, not recruiting
      Site FR33002
      Poitiers, Nouvelle-Aquitaine, France, 86021
      Withdrawn
      Indiana University Cancer Center
      Indianapolis, IN, United States, 46077
      Active, not recruiting
      Site IT39005
      Milano, Italy
      Completed
      Memorial Sloan Kettering Cancer Center
      New York, NY, United States, 10065
      Withdrawn
      Karmanos Cancer Institute
      Detroit, MI, United States, 48201
      Completed
      UCLA Medical Center
      Santa Monica, CA, United States, 90404
      Active, not recruiting
      Site FR33003
      Pessac, Nouvelle-Aquitaine, France, 33604
      Completed
      Weill Cornell Medical College
      New York, NY, United States, 10065
      Active, not recruiting
      Site IT39004
      Padova, Italy
      Completed
      The Angeles Clinic and Research Institute
      Los Angeles, CA, United States, 90025
      Active, not recruiting
      Site IT39003
      Pisa, Italy
      Active, not recruiting
      University of Chicago
      Chicago, IL, United States, 60637
      Withdrawn
      Sanford Cancer Center
      Sioux Falls, SD, United States, 57104
      Active, not recruiting
      Site FR33004
      Paris, Paris, France, 75015
      Active, not recruiting
      Site FR33001
      Brest, France
      Withdrawn
      Virginia Cancer Specialists
      Fairfax, VA, United States, 22031
      Active, not recruiting
      Site IT39002
      Napoli, Italy
      Active, not recruiting
      Site JP81001
      Chiba, Japan
      Withdrawn
      Georgetown Univ Hospital
      Washington, DC, United States, 20007
      Active, not recruiting
      Site JP81003
      Tokyo, Japan
      Active, not recruiting
      Site JP81002
      Tokyo, Japan
      Active, not recruiting
      Mass General / North Shore Can
      Boston, MA, United States, 02114
      Active, not recruiting
      Site KR82001
      Seoul, Republic of Korea
      Active, not recruiting
      Site KR82002
      Seongnam-si, Republic of Korea
      Active, not recruiting
      Site TW88601
      Taichung, Taiwan, Province of China
      Active, not recruiting
      Site TW88602
      Tainan, Tainan, Taiwan, Province of China, 70403

      Frequently Asked Questions

      Are clinical trials only for people with advanced cancer?

      While some clinical trials may focus on more advanced cancers, many trials are open to patients at various stages of their cancer. Each study has rules about who can take part. For example, only patients in a certain age group or those who have a certain type of tumor may be able to join.

      Will I have to stop my current treatment to participate in a clinical trial?

      Sometimes researchers want participants to keep taking their current treatments during a clinical trial. Other times, you may need to stop your current treatments for a while. If the investigational treatment doesn't work, you can usually go back to your original treatment plan.

      Should I be worried about getting a placebo?

      In cancer clinical trials, a placebo is only used if there is no other treatment for that type of cancer. This helps compare an investigational treatment to the placebo. Placebos are rarely used in cancer trials because the best available treatment, called the “standard of care”, is usually given instead.

      Do I need a referral from my doctor to take part in a study?

      Your doctor may not know about all the opportunities for clinical trials that are available to you. Talk to your doctor or other medical provider about clinical trial information that you find. They can help you decide if a clinical trial is right for you. If you do not find any options on this website, we recommend you visit an online public registry website like clinicaltrials.gov to see a wide variety of available clinical trials.

      Explore More

      1

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      3

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