Efficacy and Safety of IMAB362 in Combination With the EOX Regimen for CLDN18.2-positive Gastric Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

252

Participants

Timeline

Start Date

July 19, 2012

Primary Completion Date

January 31, 2019

Study Completion Date

January 31, 2019

Conditions
CLDN18.2-positive Adenocarcinoma of the Gastroesophageal JunctionCLDN18.2-positive Adenocarcinoma of EsophagusCLDN18.2-positive Gastric Adenocarcinoma
Interventions
DRUG

epirubicin

Epirubicin will be administered at a dose of 50 mg/m\^2 as a 15-minute intravenous infusion on day 1 of each cycle.

DRUG

oxaliplatin

Oxaliplatin will be administered at a dose of 130 mg/m\^2 as a 2-hour intravenous infusion on day 1 of each cycle.

DRUG

capecitabine

The daily dose of capecitabine will be 1250 mg/m\^2. Capecitabine tablets to be given once daily at a dose of 625 mg/m\^2 orally in the evening of day 1 of each cycle and twice daily at a dose of 625 mg/m\^2 orally on days 2 to 21 of each cycle; the morning dose of capecitabine on day 1 of each cycle to be omitted due to administration of zolbetuximab, epirubicin and oxaliplatin.

DRUG

zolbetuximab

Two different formats of zolbetuximab, comprising different strengths, to be provided. Vials contained 22 mg or 105 mg of zolbetuximab. Prior to administration, zolbetuximab will be reconstituted with 1.1 mL (22 mg zolbetuximab vials) or 5.0 mL (105 mg zolbetuximab vials) water for injection, which will result in a concentration of 20 mg/mL zolbetuximab. The extractable volume per vial will be 1 mL (for 22 mg zolbetuximab vials) or 5 mL (for 105 mg zolbetuximab vials). The reconstituted solution will be further diluted with sodium chloride 0.9% to a final concentration of 2 mg/mL zolbetuximab. Zolbetuximab will be administered as an intravenous infusion over 2 to 3 hours.

Trial Locations (48)

Unknown

Site BUL004, Plovdiv

Site BUL001, Sofia

Site BUL003, Sofia

Site BUL005, Sofia

Site BUL002, Varna

Site CZE002, Olomouc

Site CZE001, Znojmo

Site GER012, Bielefeld

Site GER029-01, Bochum

Site GER029, Bochum

Site GER010, Dresden

Site GER001, Essen

Site GER017, Frankfurt

Site GER005, Halle

Site GER020, Leipzig

Site GER016, Münster

Site GER013, Pinneberg

Site LAT001, Liepāja

Site LAT002, Riga

Site RUS011, Arkhangelsk

Site RUS016, Bryansk

Site RUS006, Chelyabinsk

Site RUS007, Ivanovo

Site RUS009, Kursk

Site RUS001, Moscow

Site RUS002, Obninsk

Site RUS023, Omsk

Site RUS014, Orenburg

Site RUS012, Oryol

Site RUS005, Pyatigorsk

Site RUS019, Ryazan

Site RUS003, Saint Petersburg

Site RUS010, Saint Petersburg

Site RUS015, Saint Petersburg

Site RUS017, Veliky Novgorod

Site RUS013, Yaroslavl

Site UKR003, Dnipropetrovsk

Site UKR001, Donetsk

Site UKR002, Donetsk

Site UKR008, Ivano-Frankivsk

Site UKR005, Kharkiv

Site UKR007, Kyiv

Site UKR006, Lviv

Site UKR015, Poltava

Site UKR004, Simferopol

Site UKR011, Sumy

Site UKR010, Uzhhorod

Site UKR009, Zaporizhia

All Listed Sponsors
lead

Astellas Pharma Global Development, Inc.

INDUSTRY

NCT01630083 - Efficacy and Safety of IMAB362 in Combination With the EOX Regimen for CLDN18.2-positive Gastric Cancer | Biotech Hunter | Biotech Hunter