Detail

Study ID: Astellas 8951-CL-0301

Title:

A Phase 3, Global Multi-Center, Double-Blind, Randomized, Efficacy Study of IMAB362 Plus mFOLFOX6 Compared with Placebo Plus mFOLFOX6 as First-line Treatment of Subjects with Claudin (CLDN)18.2 Positive, HER2-Negative, Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

Description:
Title: A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus mFOLFOX6 Compared with Placebo Plus mFOLFOX6 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 Description: A phase 3, global, multicenter, double-blind, randomized, investigational study of Zolbetuximab (IMAB362) plus mFOLFOX6 compared with placebo plus mFOLFOX6 in subjects with Claudin (CLDN) 18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. 4 Key Inclusion/Exclusion Criteria including Age Range If Applicable: • Confirmed diagnosis of gastric or GEJ adenocarcinoma in patients ≥ 18 years of age;• CLDN18.2 positive, HER2-negative tumor; • No prior systemic chemotherapy for locally advanced unresectable or metastatic gastric orGEJ adenocarcinoma; • Patient may have received either neoadjuvant or adjuvant chemotherapy as long as it was completed at least 6 months prior to the first dose of study treatment
Location:
Sioux Falls Region
Principal Investigator:
Jonathan Bleeker, MD
Disease:
GE Junction, Gastric
Stage:
Phase III
Status:
Active - Open to Accrual