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ASP8951

DRUG5 trials

Sponsors

Astellas Pharma Global Development Inc.

Conditions

Advanced cancer of the stomach or the gastroesophageal junctionClaudin (CLDN)18.2-PositiveFirst Line Treatment in Subjects with Claudin 18.2 (CLDN18.2) PositiveGastric AdenocarcinomaGastric CancerGastroesophageal Junction AdenocarcinomaHER2-NegativeLocally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

Phase 2

Phase 3

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
Active, not recruitingCTIS2024-511365-11-00
Astellas Pharma Global Development Inc.Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
Start: 2018-11-27Target: 210Updated: 2026-01-15
A Phase 3, Global, Multi-Center, 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
Active, not recruitingCTIS2024-511648-16-00
Astellas Pharma Global Development Inc.Claudin (CLDN)18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
Start: 2019-01-04Target: 108Updated: 2025-10-03
A Phase 3, Double-blind, Randomized Study of Zolbetuximab in Combination with Pembrolizumab and Chemotherapy (CAPOX or mFOLFOX6) in First-line Treatment of Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma in Participants Whose Tumors are HER2-negative, Claudin (CLDN) 18.2-positive and Programmed Death-ligand 1 (PD-L1)-positive
RecruitingCTIS2024-519773-19-00
Astellas Pharma Global Development Inc.Gastric Adenocarcinoma, Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
Start: 2025-07-31Target: 201Updated: 2026-01-26