ASP8951
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
A Phase 2 Study of Zolbetuximab (IMAB362) as Monotherapy and in Combination with Chemotherapy and/or Immunotherapy in Subjects with Metastatic or Locally Advanced Unresectable Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma and Locoregional Gastric or GEJ Adenocarcinoma Whose Tumors are Claudin (CLDN) 18.2 Positive.
Active, not recruitingCTIS2024-511649-21-00
Start: 2018-08-01Target: 48Updated: 2026-01-23
A Phase 2, Open-Label, Randomized Study to Assess the Efficacy and Safety of Zolbetuximab (IMAB362) in Combination with Nab-Paclitaxel and Gemcitabine (Nab-P + GEM) as First Line Treatment in Subjects with Claudin 18.2 (CLDN18.2) Positive, Metastatic Pancreatic Adenocarcinoma
Active, not recruitingCTIS2024-510985-17-00
Start: 2019-03-14Target: 113Updated: 2025-10-03
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
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
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
Start: 2025-07-31Target: 201Updated: 2026-01-26