Zolbetuximab
- Generic Name
- Zolbetuximab
- Brand Names
- Vyloy
- Drug Type
- Biotech
- Chemical Formula
- -
- 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).
- Associated Conditions
- -
- Associated Therapies
- -
A Phase Ib/II Trial of Neoadjuvant Zolbetuximab Plus Docetaxel, Oxaliplatin and S-1 Chemotherapy in Patients with Locally Advanced Gastric Cancer
- Conditions
- Interventions
- First Posted Date
- 2024-12-13
- Last Posted Date
- 2024-12-20
- Lead Sponsor
- Asan Medical Center
- Target Recruit Count
- 57
- Registration Number
- NCT06732856
- Locations
- π°π·
Asan Medical Center, Seoul, Korea, Republic of
A Study of Zolbetuximab With Chemotherapy in Adults With Pancreatic Cancer
- Conditions
- Interventions
- First Posted Date
- 2024-05-02
- Last Posted Date
- 2024-11-25
- Lead Sponsor
- Astellas Pharma Global Development, Inc.
- Target Recruit Count
- 12
- Registration Number
- NCT06396091
- Locations
- πΊπΈ
Providence Medical Foundation, Fullerton, California, United States
πΊπΈNorton Cancer Institute, Louisville, Kentucky, United States
πΊπΈVirginia Mason Medical Center, Seattle, Washington, United States
Early Access Program for Zolbetuximab
- First Posted Date
- 2023-09-21
- Last Posted Date
- 2024-11-25
- Lead Sponsor
- Astellas Pharma Global Development, Inc.
- Registration Number
- NCT06048081
- Locations
- πΊπΈ
Site US10001, Morristown, New Jersey, United States
π©πͺDE49020, Berlin, Germany
π©πͺDE49021, Chemnitz, Germany
A Pharmacokinetic Study of Zolbetuximab (IMAB362) in Chinese Subjects With Locally Advanced Unresectable or Metastatic Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma
- Conditions
- Interventions
- First Posted Date
- 2019-09-12
- Last Posted Date
- 2024-11-20
- Lead Sponsor
- Astellas Pharma China, Inc.
- Target Recruit Count
- 12
- Registration Number
- NCT04086758
- Locations
- π¨π³
Site CN86001, Guangzhou, China
A Study of Zolbetuximab (IMAB362) in Adults With Pancreatic Cancer
- Conditions
- Interventions
- First Posted Date
- 2019-01-25
- Last Posted Date
- 2024-11-01
- Lead Sponsor
- Astellas Pharma Global Development, Inc.
- Target Recruit Count
- 393
- Registration Number
- NCT03816163
- Locations
- πΊπΈ
Lynn Cancer Institute, Boca Raton, Florida, United States
πΉπ·Site TR90002, Istanbul, Turkey
πΊπΈSt. Joseph Heritage Medical Group, Fullerton, California, United States
A 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
- Conditions
- Interventions
- First Posted Date
- 2018-08-31
- Last Posted Date
- 2024-10-03
- Lead Sponsor
- Astellas Pharma Global Development, Inc.
- Target Recruit Count
- 507
- Registration Number
- NCT03653507
- Locations
- πΊπΈ
Parkland Hospital, Dallas, Texas, United States
πΊπΈUniversity of Kansas Cancer Center and Medical Pavilion, Fairway, Kansas, United States
π΅πΉSite PT35109, Braga, Portugal
A Study of IMAB362 in Japanese Subjects With Locally Advanced or Metastatic Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma
- Conditions
- 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
- π―π΅
Site JP00001, Kashiwa, Chiba, Japan
A Study of Zolbetuximab (IMAB362) in Adults With Gastric Cancer
- Conditions
- Interventions
- First Posted Date
- 2018-04-23
- Last Posted Date
- 2024-11-18
- Lead Sponsor
- Astellas Pharma Global Development, Inc.
- Target Recruit Count
- 143
- Registration Number
- NCT03505320
- Locations
- π«π·
Site FR33003, Pessac, Nouvelle-Aquitaine, France
π«π·Site FR33002, Poitiers, Nouvelle-Aquitaine, France
π«π·Site FR33001, Brest, France
A Phase 3 Efficacy, Safety and Tolerability Study of Zolbetuximab (Experimental Drug) Plus mFOLFOX6 Chemotherapy Compared to Placebo Plus mFOLFOX6 as Treatment for Gastric and Gastroesophageal Junction (GEJ) Cancer
- Conditions
- Interventions
- First Posted Date
- 2018-04-20
- Last Posted Date
- 2024-10-07
- Lead Sponsor
- Astellas Pharma Global Development, Inc.
- Target Recruit Count
- 566
- Registration Number
- NCT03504397
- Locations
- πΊπΈ
St. Jude Hospital Yorba Linda, Fullerton, California, United States
πΊπΈUniversity of Chicago, Chicago, Illinois, United States
πΊπΈDana 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
- 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
- π±π»
Riga East University Hospital, LLC, Latvian Oncology Center, Riga, Latvia
π©πͺLeipzig University Hospital, University Cancer Center (UCCL), Leipzig, Germany
π©πͺInstitut fΓΌr Klinische Forschung, Krankenhaus Nordwest GmbH, Frankfurt, Hessen, Germany
Drug Development Updates
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