Zolbetuximab
- Generic Name
- Zolbetuximab
- Brand Names
- Vyloy
- Drug Type
- Biotech
- CAS Number
- 1496553-00-4
- Unique Ingredient Identifier
- TF5MPQ8WGY
- Background
Zolbetuximab is under investigation in clinical trial NCT01630083 (Efficacy and Safety of IMAB362 in Combination With the EOX Regimen for CLDN18.2-positive Gastric Cancer).
A Study of IMAB362 in Japanese Subjects With Locally Advanced or Metastatic Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma
- Conditions
- Gastric CancerGastro-esophageal Junction (GEJ) Cancer
- Interventions
- First Posted Date
- 2018-05-18
- Last Posted Date
- 2024-12-02
- Lead Sponsor
- Astellas Pharma Inc
- Target Recruit Count
- 18
- Registration Number
- NCT03528629
- Locations
- 🇯🇵
Site JP00001, Kashiwa, Chiba, Japan
A Study of Zolbetuximab (IMAB362) in Adults With Gastric Cancer
- Conditions
- Pharmacokinetics of ZolbetuximabGastric CancerPharmacokinetics of OxaliplatinGastro-esophageal Junction (GEJ) CancerPharmacokinetics of Fluorouracil Bolus (5-FU)
- Interventions
- First Posted Date
- 2018-04-23
- Last Posted Date
- 2025-04-18
- Lead Sponsor
- Astellas Pharma Global Development, Inc.
- Target Recruit Count
- 143
- Registration Number
- NCT03505320
- Locations
- 🇫🇷
Site FR33003, Pessac, Nouvelle-Aquitaine, France
🇫🇷Site FR33002, Poitiers, Nouvelle-Aquitaine, France
🇫🇷Site FR33001, Brest, France
A Study to Compare Zolbetuximab (IMAB362) and Chemotherapy With Placebo and Chemotherapy in Adults With Gastric Cancer.
- Conditions
- Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or CancerLocally Advanced Unresectable Gastric Adenocarcinoma or CancerMetastatic Gastric Adenocarcinoma or CancerMetastatic Gastroesophageal Junction (GEJ) Adenocarcinoma
- Interventions
- First Posted Date
- 2018-04-20
- Last Posted Date
- 2025-04-20
- Lead Sponsor
- Astellas Pharma Global Development, Inc.
- Target Recruit Count
- 565
- Registration Number
- NCT03504397
- Locations
- 🇺🇸
St. Jude Hospital Yorba Linda, Fullerton, California, United States
🇺🇸University of Chicago, Chicago, Illinois, United States
🇺🇸Dana Farber Cancer Institute, Boston, Massachusetts, United States
Safety and Activity of IMAB362 in Combination With Zoledronic Acid and Interleukin-2 in CLDN18.2-positive Gastric Cancer
- Conditions
- CLDN18.2-positive Gastric AdenocarcinomaCLDN18.2-positive Adenocarcinoma of the Gastroesophageal JunctionCLDN18.2-positive Adenocarcinoma of Esophagus
- Interventions
- First Posted Date
- 2012-08-24
- Last Posted Date
- 2024-11-14
- Lead Sponsor
- Astellas Pharma Global Development, Inc.
- Target Recruit Count
- 29
- Registration Number
- NCT01671774
- Locations
- 🇱🇻
Riga East University Hospital, LLC, Latvian Oncology Center, Riga, Latvia
🇩🇪Leipzig University Hospital, University Cancer Center (UCCL), Leipzig, Germany
🇩🇪Institut für Klinische Forschung, Krankenhaus Nordwest GmbH, Frankfurt, Hessen, Germany
Efficacy and Safety of IMAB362 in Combination With the EOX Regimen for CLDN18.2-positive Gastric Cancer
- Conditions
- CLDN18.2-positive Adenocarcinoma of the Gastroesophageal JunctionCLDN18.2-positive Gastric AdenocarcinomaCLDN18.2-positive Adenocarcinoma of Esophagus
- Interventions
- First Posted Date
- 2012-06-28
- Last Posted Date
- 2024-11-13
- Lead Sponsor
- Astellas Pharma Global Development, Inc.
- Target Recruit Count
- 252
- Registration Number
- NCT01630083
- Locations
- 🇷🇺
Site RUS009, Kursk, Russian Federation
🇺🇦Site UKR003, Dnipropetrovsk, Ukraine
🇺🇦Site UKR007, Kyiv, Ukraine
Efficacy and Safety Study of Multiple Doses of IMAB362 in Patients With Advanced Gastroesophageal Cancer
- First Posted Date
- 2010-09-09
- Last Posted Date
- 2024-12-02
- Lead Sponsor
- Ganymed Pharmaceuticals GmbH
- Target Recruit Count
- 54
- Registration Number
- NCT01197885
- Locations
- 🇧🇬
Complex Oncology Center, Veliko Turnovo, Bulgaria
🇧🇬MHAT "St.Marina", Varna, Bulgaria
🇩🇪Universitätsklinikum Halle, Halle, Germany
Drug Development Updates
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