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    A Study of Zolbetuximab (IMAB362) in Adults With Pancreatic Cancer (8951-CL-5201) (NCT03816163)
    Phase 2
    Astellas Pharma Global Development, Inc.
    Active, not recruiting
    Last update posted :
    01/31/2025
    Initiation :
    03/15/2019
    Primary completion :
    08/31/2026
    Completion :
    08/31/2026
    CLDN18
    |
    CLDN18.2 expression
    |
    gemcitabine • albumin-bound paclitaxel • Vyloy (zolbetuximab-clzb)
    Zolbetuximab Claudin18.2 Positive, HER2 Negative, Advanced Gastric Cancer (NCT06767449)
    Phase N/A
    Yonsei University
    Recruiting
    Last update posted :
    01/09/2025
    Initiation :
    12/01/2024
    Primary completion :
    12/01/2026
    Completion :
    12/01/2026
    PD-L1 • CLDN18
    |
    PD-L1 expression
    |
    Vyloy (zolbetuximab-clzb)
    A Study of IMAB362 in Japanese Subjects With Locally Advanced or Metastatic Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma (8951-CL-0104) (NCT03528629)
    Phase N/A
    Astellas Pharma Inc
    Completed
    Last update posted :
    06/14/2024
    Initiation :
    05/17/2018
    Primary completion :
    06/09/2020
    Completion :
    06/09/2020
    CLDN18
    |
    Vyloy (zolbetuximab-clzb)
    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 (Spotlight) (NCT03504397)
    Phase 3
    Astellas Pharma Global Development, Inc.
    Active, not recruiting
    Last update posted :
    06/11/2024
    Initiation :
    06/21/2018
    Primary completion :
    09/09/2022
    Completion :
    03/31/2025
    HER-2 • CLDN18
    |
    HER-2 negative • CLDN18.2 expression
    |
    5-fluorouracil • oxaliplatin • leucovorin calcium • Vyloy (zolbetuximab-clzb)
    Early Access Program for Zolbetuximab (NCT06048081)
    Phase N/A
    Astellas Pharma Global Development, Inc.
    Available
    Last update posted :
    05/23/2024
    HER-2 • CLDN18
    |
    HER-2 negative
    |
    5-fluorouracil • oxaliplatin • leucovorin calcium • Vyloy (zolbetuximab-clzb)
    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 (GLOW) (NCT03653507)
    Phase 3
    Astellas Pharma Global Development, Inc.
    Active, not recruiting
    Last update posted :
    05/17/2024
    Initiation :
    11/28/2018
    Primary completion :
    10/25/2022
    Completion :
    03/31/2025
    HER-2 • CLDN18
    |
    HER-2 negative • CLDN18.2 expression
    |
    capecitabine • oxaliplatin • Vyloy (zolbetuximab-clzb)
    A Study to Assess the Antitumor Activity, Safety, Pharmacokinetics and Biomarkers of Zolbetuximab (IMAB362) in Participants With Claudin (CLDN) 18.2 Positive, Metastatic or Advanced Unresectable Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma and Locoregional Gastric or GEJ Adenocarcinoma (ILUSTRO) (NCT03505320)
    Phase 2
    Astellas Pharma Global Development, Inc.
    Recruiting
    Last update posted :
    05/09/2024
    Initiation :
    06/29/2018
    Primary completion :
    04/30/2025
    Completion :
    12/31/2026
    PD-L1 • CLDN18
    |
    PD-L1 expression • HER-2 negative • CLDN18.2 expression • CLDN18.2 positive
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • docetaxel • 5-fluorouracil • oxaliplatin • leucovorin calcium • Vyloy (zolbetuximab-clzb)
    Efficacy and Safety of IMAB362 in Combination With the EOX Regimen for CLDN18.2-positive Gastric Cancer (FAST) (NCT01630083)
    Phase 2
    Astellas Pharma Global Development, Inc.
    Completed
    Last update posted :
    01/18/2020
    Initiation :
    07/19/2012
    Primary completion :
    01/31/2019
    Completion :
    01/31/2019
    HER-2 • CLDN18
    |
    HER-2 negative • CLDN18.2 expression
    |
    capecitabine • oxaliplatin • epirubicin • Vyloy (zolbetuximab-clzb)
    Safety and Activity of IMAB362 in Combination With Zoledronic Acid and Interleukin-2 in CLDN18.2-positive Gastric Cancer (NCT01671774)
    Phase 1
    Astellas Pharma Global Development, Inc.
    Completed
    Last update posted :
    10/18/2019
    Initiation :
    10/16/2012
    Primary completion :
    10/13/2014
    Completion :
    10/13/2014
    CLDN18
    |
    CLDN18.2 expression
    |
    Vyloy (zolbetuximab-clzb) • zoledronic acid
    Efficacy and Safety Study of Multiple Doses of IMAB362 in Patients With Advanced Gastroesophageal Cancer (NCT01197885)
    Phase 2
    Ganymed Pharmaceuticals GmbH
    Completed
    Last update posted :
    07/02/2017
    Initiation :
    09/01/2010
    Primary completion :
    08/01/2015
    Completion :
    08/01/2015
    CLDN18
    |
    CLDN18.2 expression
    |
    Vyloy (zolbetuximab-clzb)
    Safety and Tolerability Study of Claudiximab in Patients With Advanced Gastroesophageal Cancer (NCT00909025)
    Phase 1
    Ganymed Pharmaceuticals GmbH
    Completed
    Last update posted :
    07/02/2017
    Initiation :
    05/01/2009
    Primary completion :
    05/01/2010
    Completion :
    05/01/2010
    CLDN18
    |
    CLDN18.2 expression
    |
    Vyloy (zolbetuximab-clzb)