A Study of Zolbetuximab (IMAB362) in Adults With Gastric Cancer

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

143

Participants

Timeline

Start Date

June 29, 2018

Primary Completion Date

July 31, 2026

Study Completion Date

May 31, 2027

Conditions
Pharmacokinetics of ZolbetuximabGastric CancerGastro-esophageal Junction (GEJ) CancerPharmacokinetics of OxaliplatinPharmacokinetics of Fluorouracil Bolus (5-FU)
Interventions
DRUG

zolbetuximab

Zolbetuximab will be administered as a minimum 2-hour IV infusion.

DRUG

oxaliplatin

Oxaliplatin will be administered as a 2-hour IV infusion.

DRUG

leucovorin

Leucovorin will be administered as a 2-hour IV infusion.

DRUG

fluorouracil

Fluorouracil will be administered as IV bolus over 5 to 15 minutes and continuous IV infusion over 46 to 48 hours or per institutional guidelines.

DRUG

Pembrolizumab

Pembrolizumab will be administered intravenously over 30 minutes.

DRUG

folinic acid

Folnic acid will be administered as a 2-hour IV infusion.

DRUG

nivolumab

Nivolumab will be administered intravenously according to institutional standards.

DRUG

Docetaxel

Docetaxel will be administered as a 1-hour IV infusion.

Trial Locations (21)

10065

Memorial Sloan Kettering Cancer Center, New York

Weill Cornell Medical College, New York

33604

Site FR33003, Pessac

60637

University of Chicago, Chicago

70403

Site TW88602, Tainan City

75015

Site FR33004, Paris

86021

Site FR33002, Poitiers

90025

The Angeles Clinic and Research Institute, Los Angeles

90404

UCLA Medical Center, Santa Monica

02114

Mass General / North Shore Can, Boston

Unknown

Site FR33001, Brest

Site IT39005, Milan

Site IT39002, Napoli

Site IT39004, Padua

Site IT39003, Pisa

Site JP81001, Chiba

Site JP81002, Tokyo

Site JP81003, Tokyo

Site KR82002, Seongnam-si

Site KR82001, Seoul

Site TW88601, Taichung

All Listed Sponsors
lead

Astellas Pharma Global Development, Inc.

INDUSTRY

NCT03505320 - A Study of Zolbetuximab (IMAB362) in Adults With Gastric Cancer | Biotech Hunter | Biotech Hunter