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

Official Title

A Phase 3, Global, Multi-Centre, 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

Summary:

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.

Trial Description

Primary Outcome:

• Progression Free Survival (PFS)

Secondary Outcome:

• Overall Survival (OS)
• Objective Response Rate (ORR)
• Duration Of Response (DOR)
• Safety and tolerability assessed by adverse events (AEs)
• Number of participants with laboratory assessments abnormalities and or adverse events
• Number of participants with vital signs abnormalities and or adverse events
• Number of participants with electrocardiograms (ECG) abnormalities and or adverse events
• Number of participants with Eastern Cooperative Oncology Group (ECOG) performance status abnormalities and or adverse events
• Health Related Quality of Life (HRQoL) measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC-QLQ-C30)
• Health Related Quality of Life (HRQoL) measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Oesophago-Gastric Module 25 (QLQ-OG25) questionnaire plus EORTC-QLQ-STO22 Belching subscale
• Health Related Quality of Life (HRQoL) measured by the Global Pain (GP) questionnaire
• Health Related Quality of Life (HRQoL) measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) questionnaire
• Pharmacokinetics (PK) of zolbetuximab: Concentration Immediately Prior to Dosing at multiple dosing (Ctrough)
• Number of anti-drug antibody (ADA) Positive Participants

The study consists of the following periods: screening; treatment; post-treatment follow up, safety follow up, long term and survival follow-up.

View this trial on ClinicalTrials.gov