Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06177041
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2023-12-11
Brief Title:
M108 Plus CAPOX Versus Placebo Plus CAPOX as First-line Treatment for Claudin CLDN 182-Positive HER2-Negative PD-L1 CPS5 Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction GEJ Adenocarcinoma
Sponsor:
FutureGen Biopharmaceutical Beijing Co Ltd
Organization:
FutureGen Biopharmaceutical Beijing Co Ltd
Study Overview
Official Title:
A Phase 3 Multi-Center Double-Blind Randomized Efficacy and Safety Study of M108 Monoclonal Antibody Plus CAPOX Versus Placebo Plus CAPOX as First-line Treatment for Claudin CLDN 182-Positive HER2-Negative PD-L1 CPS5 Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction GEJ Adenocarcinoma
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
GastricGEJ adenocarcinoma which is one of the major leading causes of cancer-related deaths worldwide is a global challenge to human health However standard chemotherapy has limited efficacy in advanced gastric cancer and there is an urgent need to explore and develop new therapeutic targets and combination therapy modalities The main purpose of this study is to explore the efficacy of M108 monoclonal antibody plus capecitabine and oxaliplatin CAPOX versus placebo plus CAPOX as first-line treatment measured by progression free survival PFS This study will also evaluate safety tolerability pharmacokinetics and the immunogenicity profile of M108 monoclonal antibody as well as its effects on quality of life
Detailed Description:
The aim of this phase 3 double-blind randomized placebo-controlled study is to explore the efficacy and safety of M108 monoclonal antibody plus chemotherapy versus placebo plus chemotherapy as first-line treatment for Claudin CLDN 182-Positive HER2-Negative PD-L1 CPS5 locally advanced or metastatic gastricGEJ adenocarcinoma Patients will be randomized in a 11 ration to receive M108 monoclonal antibody plus chemotherapy or placebo plus chemotherapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None