A Study of Zolbetuximab Plus CAPOX Compared With Placebo Plus CAPOX as First-line Treatment of Subjects With Claudin 18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Investigator: Maen Abdelrahim, MD

Study Coordinator: Juan Morales Viera

Status: Enrolling

ClinicalTrials.gov Number: NCT03653507

Phone: 786.803.2333

Protocol Number: Pro00020925

Description

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, 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. UNDER TEMPORARY HOLD FROM SPONSOR DUE TO COVID19
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