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 (GLOW).

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

507

Participants

Timeline

Start Date

November 28, 2018

Primary Completion Date

October 25, 2022

Study Completion Date

March 31, 2026

Conditions
Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or CancerLocally Advanced Unresectable Gastric Adenocarcinoma or CancerMetastatic Gastric Adenocarcinoma or CancerMetastatic Gastroesophageal Junction (GEJ) Adenocarcinoma
Interventions
DRUG

zolbetuximab

Zolbetuximab were administered as a minimum 2-hour IV infusion.

DRUG

oxaliplatin

Oxaliplatin were administered as a 2-hour IV infusion.

DRUG

capecitabine

Capecitabine were administered orally twice daily (bid).

DRUG

placebo

Placebo were administered as a minimum 2-hour IV infusion.

Trial Locations (165)

10021

Weill Cornell Medical College (WCMC), New York

10467

Montefiore Medical Center (MMC), The Bronx

29316

Prisma Health Cancer Institute, Boiling Springs

66205

University of Kansas Cancer Center and Medical Pavilion, Fairway

70121

Ochsner Clinic CCOP, New Orleans

75390

Parkland Hospital, Dallas

University of Texas Southwestern Medical Center, Dallas

77030

Houston Methodist Cancer Center and Institute of Academic Medicine - Oncology, Houston

84106

Utah Cancer Specialist, Salt Lake City

87109

New Mexico Oncology Hematology, Albuquerque

93940

Pacific Cancer Care, Monterey

Unknown

Site AR54009, Buenos Aires

Site GB44005, Northwood

Site AR54006, Pergamino

Site AR54001, San Miguel de Tucumán

Site AR54004, San Miguel de Tucumán

Site AR54003, Viedma

Site CA15003, Chicoutimi

Site CA15002, Rimouski

Site CA15004, Calgary

Site CN86034, Fuzhou

Site CN86037, Fuzhou

Site CN86032, Haikou

Site CN86012, Zhengzhou

Site CN86029, Changsha

Site CN86043, Hengyang

Site CN86027, Suzhou

Site CN86046, Wuxi

Site CN86007, Hangzhou

Site CN86044, Baoding

Site CN86035, Beijing

Site CN86050, Beijing

Site CN86025, Bengbu

Site CN86002, Changchun

Site CN86049, Changchun

Site CN86053, Changchun

Site CN86021, Changzhou

Site CN86039, Chengdu

Site CN86052, Dalian

Site CN86054, Dalian

Site CN86015, Fuzhou

Site CN86001, Guangzhou

Site CN86042, Guangzhou

Site CN86051, Haebrin

Site CN86036, Hangzhou

Site CN86038, Linyi

Site CN86016, Nanjing

Site CN86045, Nanning

Site CN86014, Shanghai

Site CN86026, Shantou

Site CN86047, Shenyang

Site CN86017, Shijiazhuang

Site CN86009, Tianjin

Site CN86040, Tianjin

Site CN86031, Ürümqi

Site CN86004, Wuhan

Site CN86005, Wuhan

Site CN86013, Xi'an

Site CN86030, Xiamen

Site CN86011, Xuzhou

Site CN86024, Zhengzhou

Site HR38501, Varaždin

Site HR38502, Zagreb

Site HR38503, Zagreb

Site GR30001, Athens

Site GR30004, Heraklion

Site GR30003, Larissa

Site GR30005, Neo Faliro, Piraeus

Site GR30007, Rio Patras

Site GR30002, Thessaloniki

Site GR3006, Thessaloniki

Site IE35301, Dublin

Site IE35302, Dublin

Site JP81007, Fukuoka

Site JP81008, Akashi

Site JP81003, Kawasaki

Site JP81001, Yokohama

Site JP81010, Suita

Site JP81005, Utsunomiya

Site JP81002, Chiba

Site JP81006, Kashiwa

Site JP81004, Kita-gun

Site JP81012, Kōtoku

Site JP81009, Matsuyama

Site JP81011, Tsukiji

Site MY60001, George Town

Site MY60004, Kota Kinabalu

Site MY60002, Kuala Lumpur

Site MY60003, Kuala Lumpur

Site MY60005, Kuala Lumpur

Site NL31004, Groningen

Site NL31003, Tilburg

Site PT35109, Braga

Site PT35110, Coimbra

Site PT35111, Guimarães

Site PT35102, Lisbon

Site PT35106, Lisbon

Site PT35105, Porto

Site PT35108, Porto

Site PT35104, Santa Maria da Feira

Site PT35101, Setúbal

Site PT35107, Vila Real

Site RO40002, Bucharest

Site RO40005, Cluj-Napoca

Site RO40007, Cluj-Napoca

Site RO40003, Craiova

Site RO40004, Floreşti

Site RO40001, Iași

Site RO40006, Iași

Site RO40008, Timișoara

Site KR82002, Daegu

Site KR82006, Goyang-si

Site KR82007, Gyeonggi-do

Site KR82014, Incheon

Site KR82008, Jeollanam-do

Site KR82010, Jeonju

Site KR82011, Seongnam-si

Site KR82001, Seoul

Site KR82003, Seoul

Site KR82012, Seoul

Site KR82013, Seoul

Site KR82015, Seoul

Site KR82009, Suwon

Site ES34005, A Coruña

Site ES34006, Barcelona

Site ES34009, Barcelona

Site ES34010, Barcelona

Site ES34001, Elche

Site ES34002, Madrid

Site ES34003, Madrid

Site ES34008, Madrid

Site ES34013, Madrid

Site ES34011, Málaga

Site ES34004, Pamplona

Site ES34007, Valencia

Site ES34012, Valencia

Site TW88602, Kaohsiung City

Site TW88603, Taichung

Site TW88604, Taipei

Site TW88605, Tianan

Site TH66002, Bangkok

Site TH66005, Bangkok

Site TH66007, Bangkok

Site TH66009, Bangkok

Site TH66011, Laksi

Site TH66001, Muang

Site TH66003, Muang

Site TH66006, Pathum Thani

Site TH66010, Pathumwan

Site TH66004, Songkhla

Site TH66008, Vadhana

Site TR90008, Pendik

Site TR90003, Atakum

Site TR90004, Balcalı

Site TR90012, Bornova

Site TR90001, Bursa

Site TR90002, Istanbul

Site TR90010, Istanbul

Site TR90015, Istanbul

Site TR90007, Konya

Site TR90013, Konyaalti

Site TR90011, Malatya

Site GB44002, Bristol

Site GB44004, Cardiff

Site GB44001, London

All Listed Sponsors
lead

Astellas Pharma Global Development, Inc.

INDUSTRY