Study summary

The purpose of this study is to evaluate the efficacy of zolbetuximab plus capecitabine and oxaliplatin (CAPOX) compared with placebo plus CAPOX (as first-line treatment) as measured by Progression Free Survival (PFS). This study will also evaluate efficacy, physical function, safety, and tolerability of zolbetuximab, as well as its effects on quality of life. Pharmacokinetics (PK) of zolbetuximab and the immunogenicity profile of zolbetuximab will be evaluated as well.

Additional Study Details

Phase
Phase 3
Product
zolbetuximab
Product
zolbetuximab
oxaliplatin
capecitabine
placebo
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment number
507
Show Additional Study Details

Get more information

Would you like more information about clinical trial sites that are recruiting participants for A Study of Zolbetuximab (IMAB362) Plus CAPOX Compared with Placebo Plus CAPOX as First-line Treatment of Subjects with Claudin (CLDN) 18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma? Contact us by filling out your information to the right and we’ll respond to you.

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  • A patient
  • A patient advocate
  • Algeria
  • Argentina
  • Armenia
  • Australia
  • Austria
  • Belarus
  • Belgium
  • 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
  • Guatemala
  • Hong Kong
  • Hungary
  • Iceland
  • India
  • Indonesia
  • Ireland
  • Israel
  • Italy
  • Japan
  • Jordan
  • Kazakhstan
  • Latvia
  • Lebanon
  • Lithuania
  • Macedonia
  • Malaysia
  • Mexico
  • Montenegro
  • Morocco
  • Netherlands
  • New Zealand
  • Norway
  • Panama
  • Peru
  • Philippines
  • Poland
  • Portugal
  • Puerto Rico
  • Republic of Korea
  • Republic of Moldova
  • Romania
  • Russian Federation
  • Saudi Arabia
  • Serbia
  • Singapore
  • Slovakia
  • Slovenia
  • South Africa
  • Spain
  • Sweden
  • Switzerland
  • Taiwan, Province of China
  • Thailand
  • Turkey
  • 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
    Completed
    Site KR82013
    Seoul, Republic of Korea
    Completed
    Site ES34010
    Barcelona, Spain
    Active, not recruiting
    Site HR38503
    Zagreb, Croatia
    Completed
    Site GR30006
    Thessaloniki, Greece
    Completed
    Prisma Health Cancer Institute
    Boiling Springs, SC, United States, 29316
    Completed
    Site RO40001
    Iasi, Romania
    Completed
    Site KR82015
    Seoul, Republic of Korea
    Completed
    Site GB44004
    Cardiff, Wales, United Kingdom
    Completed
    Site PT35101
    Setubal, Portugal
    Active, not recruiting
    Site PT35109
    Braga, Portugal
    Completed
    Site TR90002
    Istanbul, Turkey
    Withdrawn
    Site AR54008
    Córdoba, Argentina
    Active, not recruiting
    Site ES34009
    Barcelona, Spain
    Completed
    Site ES34004
    Pamplona, Spain
    Completed
    Utah Cancer Specialist
    Salt Lake City, UT, United States, 84106
    Completed
    Site JP81004
    Kita-gun, Kagawa, Japan
    Active, not recruiting
    Site ES34011
    Malaga, Spain
    Active, not recruiting
    Site JP81011
    Tsukiji, Japan
    Active, not recruiting
    Site CN86015
    Fuzhou, China
    Completed
    Site CN86030
    Xiamen, China
    Completed
    University of Texas Southwestern Medical Center
    Dallas, TX, United States, 75390
    Completed
    Ochsner Clinic CCOP
    New Orleans, LA, United States, 70121
    Active, not recruiting
    Site JP81002
    Chiba, Chiba, Japan
    Completed
    Site GB44005
    Northwood, United Kingdom
    Completed
    Site CN86026
    Shantou, China
    Completed
    Site ES34005
    Coruña, Spain
    Active, not recruiting
    Site PT35111
    Guimaraes, Portugal
    Active, not recruiting
    Site PT35105
    Porto, Portugal
    Active, not recruiting
    Site GB44001
    London, United Kingdom
    Completed
    Site TH66001
    Muang, Thailand
    Completed
    Site ES34007
    Valencia, Spain
    Completed
    Site AR54001
    San Miguel De Tucuman, Argentina
    Completed
    Site RO40005
    Cluj-Napoca, Romania
    Completed
    Site CN86037
    Fuzhou, Fujian, China
    Completed
    Site AR54003
    Viedma, Argentina
    Active, not recruiting
    Site JP81006
    Kashiwa, Japan
    Completed
    Site CA15004
    Calgary, Canada
    Completed
    Site CN86038
    Linyi, China
    Completed
    Site KR82008
    Jeollanam-do, Republic of Korea
    Completed
    Site TW88602
    Kaohsiung, Taiwan, Province of China
    Active, not recruiting
    Site CN86001
    Guangzhou, China
    Completed
    Site CN86016
    Nanjing, China
    Active, not recruiting
    Site TH66003
    Muang, Thailand
    Withdrawn
    Site CN86018
    Beijing, China
    Completed
    Site JP81001
    Yokohama, Kanagawa, Japan
    Active, not recruiting
    Site CN86021
    Changzhou, China
    Completed
    Site AR54004
    San Miguel de Tucumán, Argentina
    Completed
    Site GR30004
    Heraklion, Greece
    Completed
    Site MY60003
    Kuala Lumpur, Malaysia
    Completed
    Site KR82007
    Gyeonggi-do, Republic of Korea
    Completed
    Site CN86029
    Changsha, Hunan, China
    Withdrawn
    Site RO40010
    Timisoara, Romania
    Active, not recruiting
    Site KR82012
    Seoul, Republic of Korea
    Active, not recruiting
    Site TR90012
    Bornova, Turkey
    Completed
    Site CN86042
    Guangzhou, China
    Completed
    Site CN86036
    Hangzhou, China
    Completed
    Site MY60004
    Kota Kinabalu, Malaysia
    Active, not recruiting
    Site TH66011
    Laksi, Thailand
    Completed
    Site TR90004
    Balcali, Turkey
    Completed
    University of Kansas Cancer Center and Medical Pavilion
    Fairway, KS, United States, 66205
    Completed
    Site TW88605
    Tianan, Taiwan, Province of China
    Active, not recruiting
    Site CN86053
    Changchun, China
    Active, not recruiting
    Site CN86044
    Baoding, China
    Completed
    Weill Cornell Medical College (WCMC)
    New York, NY, United States, 10021
    Completed
    Site CN86011
    Xuzhou, China
    Completed
    Site CN86047
    Shenyang, China
    Withdrawn
    Site AT43002
    Salzburg, Austria
    Completed
    Site NL31004
    Groningen, Netherlands
    Active, not recruiting
    Site TH66008
    Watthana, Thailand
    Completed
    Site KR82014
    Incheon, Republic of Korea
    Completed
    Site CN86007
    Hangzhou, Zhejiang, China
    Completed
    Site TH66007
    Bangkok, Thailand
    Active, not recruiting
    Site TR90010
    Istanbul, Turkey
    Active, not recruiting
    Site PT35108
    Porto, Portugal
    Completed
    Houston Methodist Cancer Center and Institute of Academic Medicine - Oncology
    Houston, TX, United States, 77030
    Withdrawn
    Site HR38504
    Osijek, Croatia
    Completed
    Site CN86027
    Suzhou, Jiangsu, China
    Completed
    Site TR90007
    Konya, Turkey
    Completed
    Site CN86005
    Wuhan, China
    Completed
    Site IE35301
    Dublin, Ireland
    Completed
    Site ES34002
    Madrid, Spain
    Completed
    Site ES34001
    Elche, Spain
    Completed
    Site TH66009
    Bangkok, Thailand
    Completed
    Site GR30005
    Neo Faliro, Piraeus, Greece
    Completed
    Site KR82003
    Seoul, Republic of Korea
    Active, not recruiting
    Site ES34006
    Barcelona, Spain
    Active, not recruiting
    Site RO40008
    Timisoara, Romania
    Completed
    Site TR90008
    Pendik, Istanbul, Turkey
    Completed
    Site RO40003
    Craiova, Romania
    Completed
    Site RO40006
    Iasi, Romania
    Active, not recruiting
    Site CN86025
    Bengbu, China
    Completed
    Site CA15003
    Chicoutimi, Quebec, Canada
    Active, not recruiting
    Site JP81012
    Koto-ku, Japan
    Completed
    Site TH66002
    Bangkok, Thailand
    Completed
    Site CN86046
    Wuxi, Jiangsu, China
    Completed
    Site JP81005
    Utsunomiya, Tochigi, Japan
    Active, not recruiting
    Site CN86024
    Zhengzhou, China
    Withdrawn
    Mercy Clinic Oncology and Hematology
    Oklahoma City, OK, United States, 73120
    Withdrawn
    University of Southern California Norris Comprehensive Cancer Center
    Los Angeles, California, United States, 90033
    Completed
    Site CN86002
    Changchun, China
    Completed
    Site GR30003
    Larissa, Greece
    Completed
    Site CA15002
    Rimouski, Quebec, Canada
    Completed
    Site RO40002
    Bucharest, Romania
    Active, not recruiting
    Site CN86039
    Chengdu, China
    Active, not recruiting
    Site KR82002
    Daegu, Republic of Korea
    Completed
    Site ES34012
    Valencia, Spain
    Completed
    Site GR30002
    Thessaloniki, Greece
    Active, not recruiting
    Site ES34003
    Madrid, Spain
    Completed
    Site TH66004
    Songkla, Thailand
    Completed
    Site PT35110
    Coimbra, Portugal
    Completed
    Site AR54009
    Buenos Aires, Argentina
    Active, not recruiting
    Site CN86031
    Urumchi, China
    Completed
    Site GR30007
    Rio Patras, Greece
    Completed
    Site RO40007
    Cluj-Napoca, Romania
    Active, not recruiting
    Parkland Hospital
    Dallas, TX, United States, 75390
    Completed
    Site TR90015
    Istanbul, Turkey
    Active, not recruiting
    Site JP81009
    Matsuyama, Japan
    Withdrawn
    Site AT43004
    Vienna, Austria
    Active, not recruiting
    Site GB44002
    Bristol, United Kingdom
    Completed
    Site MY60002
    Kuala Lumpur, Malaysia
    Completed
    Site JP81007
    Fukuoka-shi, Fukuoka, Japan
    Active, not recruiting
    Site PT35102
    Lisboa, Portugal
    Completed
    Site CN86017
    Shijiazhuang, China
    Completed
    Site PT35104
    Santa Maria da Feira, Portugal
    Completed
    Site PT35107
    Vila Real, Portugal
    Withdrawn
    Site CN86028
    Guangzhou, China
    Completed
    Site CN86009
    Tianjin, China
    Completed
    Site IE35302
    Dublin, Ireland
    Active, not recruiting
    Site JP81003
    Kawasaki, Kanagawa, Japan
    Completed
    Site PT35106
    Lisboa, Portugal
    Completed
    Site TH66005
    Bangkok, Thailand
    Completed
    Site KR82006
    Goyang-si, Republic of Korea
    Completed
    New Mexico Oncology Hematology
    Albuquerque, NM, United States, 87109
    Active, not recruiting
    Site TW88603
    Taichung, Taiwan, Province of China
    Completed
    Site CN86043
    Hengyang, Hunan, China
    Completed
    Site TH66010
    Pathumwan, Thailand
    Completed
    Site CN86014
    Shanghai, China
    Withdrawn
    Site CA15001
    Vancouver, British Columbia, Canada
    Active, not recruiting
    Site KR82009
    Suwon, Republic of Korea
    Completed
    Site ES34013
    Madrid, Spain
    Active, not recruiting
    Site TR90013
    Konyaalti, Turkey
    Completed
    Site HR38501
    Varazdin, Croatia
    Completed
    Site CN86032
    Haikou, Hainan, China
    Withdrawn
    Site RO40009
    Bucharest, Romania
    Active, not recruiting
    Site CN86049
    Changchun, China
    Completed
    Site KR82010
    Jeonju-si, Republic of Korea
    Withdrawn
    Site CN86033
    Xiangyang, China
    Completed
    Site JP81008
    Akashi, Hyogo, Japan
    Completed
    Site CN86034
    Fuzhou, Fujian, China
    Completed
    Site TH66006
    Pathumthani, Thailand
    Completed
    Site NL31003
    Tilburg, Netherlands
    Completed
    Site GR30001
    Athens, Greece
    Active, not recruiting
    Site CN86004
    Wuhan, China
    Completed
    Site MY60005
    Kuala Lumpur, Malaysia
    Completed
    Site CN86045
    Nanning, China
    Active, not recruiting
    Site CN86050
    Beijing, China
    Active, not recruiting
    Site KR82001
    Seoul, Republic of Korea
    Completed
    Site CN86013
    Xi'an, China
    Completed
    Site TR90001
    Bursa, Turkey
    Completed
    Site MY60001
    Georgetown, Malaysia
    Completed
    Pacific Cancer Care
    Monterey, CA, United States, 93940
    Active, not recruiting
    Site RO40004
    Floresti, Romania
    Completed
    Site HR38502
    Zagreb, Croatia
    Completed
    Site CN86051
    Haebrin, China
    Active, not recruiting
    Site ES34008
    Madrid, Spain
    Withdrawn
    Site CN86048
    Jinzhou, China
    Active, not recruiting
    Site CN86012
    Zhengzhou, Henan, China
    Active, not recruiting
    Site TR90003
    Atakum, Turkey
    Completed
    Site CN86040
    Tianjin, China
    Completed
    Site TW88604
    Taipei, Taiwan, Province of China
    Completed
    Site TR90011
    Malatya, Turkey
    Active, not recruiting
    Site KR82011
    Seongnam-si, Republic of Korea
    Completed
    Site JP81010
    Suita, Osaka, Japan
    Completed
    Site CN86054
    Dalian, China
    Completed
    Site AR54006
    Pergamino, Argentina
    Completed
    Montefiore Medical Center (MMC)
    The Bronx, NY, United States, 10467
    Active, not recruiting
    Site CN86035
    Beijing, China
    Completed
    Site CN86052
    Dalian, China

    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.

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