A Study to Assess the Antitumor Activity, Safety, Pharmacokinetics and Biomarkers of Zolbetuximab (IMAB362) in Participants With Claudin (CLDN) 18.2 Positive, Metastatic or Advanced Unresectable Gastric and Gastroesophageal Junction (GEJ) Adenocarci

• Status: Active, not recruiting
• Trial end date: 2023-02-28

Summary

The purpose of this study is to determine the Objective Response Rate (ORR) of zolbetuzimab as a single agent as assessed by an independent central reader. This study will also assess the ORR and Progression Free Survival (PFS) of zolbetuximab in combination with mFOLFOX6 (with or without Nivolumab) and in combination with pembrolizumab, assess the safety and tolerability, assess the effects on CLDN18.2 expression and assess the immunogenicity and immunomodulatory effects of zolbetuximab as a single agent and in combination with mFOLFOX6 (with or without Nivolumab) and in combination with pembrolizumab. This study will also evaluate the pharmacokinetics (PK) of zolbetuximab, oxaliplatin, fluorouracil (5-FU), and pembrolizumab, evaluate health-Related Quality of Life (HRQoL), evaluate the Disease Control Rate (DCR), Duration of Response (DOR), PFS of zolbetuximab as a single agent, in combination with mFOLFOX6 (with or without Nivolumab) and in combination with pembrolizumab based on both investigator and independent central reader assessment, assess Overall Survival (OS) of zolbetuximab as a single agent and in combination with pembrolizumab.

• Phase: Phase 2

Details

• Lead Sponsor: Astellas Pharma Global Development, Inc.
• Treatments: Antibodies, Monoclonal; Fluorouracil; Folic Acid; Leucovorin; Levoleucovorin; Nivolumab; Oxaliplatin; Pembrolizumab