Study Details

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

Recruitment complete
The study is ongoing, and participants are receiving an intervention or being examined, but potential participants are not currently being recruited or enrolled.

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT03653507

Astellas Study ID

The unique identification code given by the study sponsor.

8951-CL-0302

EudraCT ID

The unique identification code given to each clinical study upon registration at EudraCT (European Union Drug Regulating Authorities Clinical Trials Database).

2018-000519-26

Condition

Stomach or Esophageal Cancer

Phase

These clinical trials are done to confirm that an experimental treatment helps participants who have a specific condition. These clinical trials often compare the experimental treatment to another treatment or, if appropriate, a placebo.

Phase 3

Age

18 Years - N/A

Sex

Female & Male

Product

zolbetuximab

Type

A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

Interventional

Trial Dates

Nov 2018 - Apr 2025

Masking

Double (Participant, Investigator)

Enrollment number

507

A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy 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

Study summary

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 our your information to the right and we’ll respond to you.

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

Site KR82013

Seoul, Republic of Korea

Site ES34010

Barcelona, Spain

Site HR38503

Zagreb, Croatia

Site GR30006

Thessaloniki, Greece

Prisma Health Cancer Institute

Boiling Springs, United States, 29316

Site RO40001

Iasi, Romania

Site KR82015

Seoul, Republic of Korea

Site GB44004

Cardiff, United Kingdom

Site PT35101

Setubal, Portugal

Site PT35109

Braga, Portugal

Site TR90002

Istanbul, Turkey

Site AR54008

Córdoba, Argentina

Site ES34009

Barcelona, Spain

Site ES34004

Pamplona, Spain

Utah Cancer Specialist

Salt Lake City, United States, 84106

Site JP81004

Kita-gun, Japan

Site ES34011

Malaga, Spain

Site JP81011

Tsukiji, Japan

Site CN86015

Fuzhou, China

Site CN86030

Xiamen, China

University of Texas Southwestern Medical Center

Dallas, United States, 75390

Ochsner Clinic CCOP

New Orleans, United States, 70121

Site JP81002

Chiba, Japan

Site GB44005

Northwood, United Kingdom

Site CN86026

Shantou, China

Site ES34005

Coruña, Spain

Site PT35111

Guimaraes, Portugal

Site PT35105

Porto, Portugal

Site GB44001

London, United Kingdom

Site TH66001

Muang, Thailand

Site ES34007

Valencia, Spain

Site AR54001

San Miguel De Tucuman, Argentina

Site RO40005

Cluj-Napoca, Romania

Site CN86037

Fuzhou, China

Site AR54003

Viedma, Argentina

Site JP81006

Kashiwa, Japan

Site CA15004

Calgary, Canada

Site CN86038

Linyi, China

Site KR82008

Jeollanam-do, Republic of Korea

Site TW88602

Kaohsiung, Taiwan, Province of China

Site CN86001

Guangzhou, China

Site CN86016

Nanjing, China

Site TH66003

Muang, Thailand

Site CN86018

Beijing, China

Site JP81001

Yokohama, Japan

Site CN86021

Changzhou, China

Site AR54004

San Miguel de Tucumán, Argentina

Site GR30004

Heraklion, Greece

Site MY60003

Kuala Lumpur, Malaysia

Site KR82007

Gyeonggi-do, Republic of Korea

Site CN86029

Changsha, China

Site RO40010

Timisoara, Romania

Site KR82012

Seoul, Republic of Korea

Site TR90012

Bornova, Turkey

Site CN86042

Guangzhou, China

Site CN86036

Hangzhou, China

Site MY60004

Kota Kinabalu, Malaysia

Site TH66011

Laksi, Thailand

Site TR90004

Balcali, Turkey

University of Kansas Cancer Center and Medical Pavilion

Fairway, United States, 66205

Site TW88605

Tianan, Taiwan, Province of China

Site CN86053

Changchun, China

Site CN86044

Baoding, China

Weill Cornell Medical College (WCMC)

New York, United States, 10021

Site CN86011

Xuzhou, China

Site CN86047

Shenyang, China

Site AT43002

Salzburg, Austria

Site NL31004

Groningen, Netherlands

Site TH66008

Watthana, Thailand

Site KR82014

Incheon, Republic of Korea

Site CN86007

Hangzhou, China

Site TH66007

Bangkok, Thailand

Site TR90010

Istanbul, Turkey

Site PT35108

Porto, Portugal

Houston Methodist Cancer Center and Institute of Academic Medicine - Oncology

Houston, United States, 77030

Site HR38504

Osijek, Croatia

Site CN86027

Suzhou, China

Site TR90007

Konya, Turkey

Site CN86005

Wuhan, China

Site IE35301

Dublin, Ireland

Site ES34002

Madrid, Spain

Site ES34001

Elche, Spain

Site TH66009

Bangkok, Thailand

Site GR30005

Neo Faliro, Piraeus, Greece

Site KR82003

Seoul, Republic of Korea

Site ES34006

Barcelona, Spain

Site RO40008

Timisoara, Romania

Site TR90008

Pendik, Turkey

Site RO40003

Craiova, Romania

Site RO40006

Iasi, Romania

Site CN86025

Bengbu, China

Site CA15003

Chicoutimi, Canada

Site JP81012

Koto-ku, Japan

Site TH66002

Bangkok, Thailand

Site CN86046

Wuxi, China

Site JP81005

Utsunomiya, Japan

Site CN86024

Zhengzhou, China

Mercy Clinic Oncology and Hematology

Oklahoma City, United States, 73120

University of Southern California Norris Comprehensive Cancer Center

Los Angeles, United States, 90033

Site CN86002

Changchun, China

Site GR30003

Larissa, Greece

Site CA15002

Rimouski, Canada

Site RO40002

Bucharest, Romania

Site CN86039

Chengdu, China

Site KR82002

Daegu, Republic of Korea

Site ES34012

Valencia, Spain

Site GR30002

Thessaloniki, Greece

Site ES34003

Madrid, Spain

Site TH66004

Songkla, Thailand

Site PT35110

Coimbra, Portugal

Site AR54009

Buenos Aires, Argentina

Site CN86031

Urumchi, China

Site GR30007

Rio Patras, Greece

Site RO40007

Cluj-Napoca, Romania

Parkland Hospital

Dallas, United States, 75390

Site TR90015

Istanbul, Turkey

Site JP81009

Matsuyama, Japan

Site AT43004

Vienna, Austria

Site GB44002

Bristol, United Kingdom

Site MY60002

Kuala Lumpur, Malaysia

Site JP81007

Fukuoka-shi, Japan

Site PT35102

Lisboa, Portugal

Site CN86017

Shijiazhuang, China

Site PT35104

Santa Maria da Feira, Portugal

Site PT35107

Vila Real, Portugal

Site CN86028

Guangzhou, China

Site CN86009

Tianjin, China

Site IE35302

Dublin, Ireland

Site JP81003

Kawasaki, Japan

Site PT35106

Lisboa, Portugal

Site TH66005

Bangkok, Thailand

Site KR82006

Goyang-si, Republic of Korea

New Mexico Oncology Hematology

Albuquerque, United States, 87109

Site TW88603

Taichung, Taiwan, Province of China

Site CN86043

Hengyang, China

Site TH66010

Pathumwan, Thailand

Site CN86014

Shanghai, China

Site CA15001

Vancouver, Canada

Site KR82009

Suwon, Republic of Korea

Site ES34013

Madrid, Spain

Site TR90013

Konyaalti, Turkey

Site HR38501

Varazdin, Croatia

Site CN86032

Haikou, China

Site RO40009

Bucharest, Romania

Site CN86049

Changchun, China

Site KR82010

Jeonju-si, Republic of Korea

Site CN86033

Xiangyang, China

Site JP81008

Akashi, Japan

Site CN86034

Fuzhou, China

Site TH66006

Pathumthani, Thailand

Site NL31003

Tilburg, Netherlands

Site GR30001

Athens, Greece

Site CN86004

Wuhan, China

Site MY60005

Kuala Lumpur, Malaysia

Site CN86045

Nanning, China

Site CN86050

Beijing, China

Site KR82001

Seoul, Republic of Korea

Site CN86013

Xi'an, China

Site TR90001

Bursa, Turkey

Site MY60001

Georgetown, Malaysia

Pacific Cancer Care

Monterey, United States, 93940

Site RO40004

Floresti, Romania

Site HR38502

Zagreb, Croatia

Site CN86051

Haebrin, China

Site ES34008

Madrid, Spain

Site CN86048

Jinzhou, China

Site CN86012

Zhengzhou, China

Site TR90003

Atakum, Turkey

Site CN86040

Tianjin, China

Site TW88604

Taipei, Taiwan, Province of China

Site TR90011

Malatya, Turkey

Site KR82011

Seongnam-si, Republic of Korea

Site JP81010

Suita, Japan

Site CN86054

Dalian, China

Site AR54006

Pergamino, Argentina

Montefiore Medical Center (MMC)

The Bronx, United States, 10467

Site CN86035

Beijing, China

Site CN86052

Dalian, China