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8951-CL-0104","lead_sponsor":"Astellas Pharma Inc","biomarkers":" CLDN18","pipe":"","alterations":" ","tags":["CLDN18"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Vyloy (zolbetuximab-clzb)"],"overall_status":"Completed","enrollment":" Enrollment 18","initiation":"Initiation: 05/17/2018","start_date":" 05/17/2018","primary_txt":" Primary completion: 06/09/2020","primary_completion_date":" 06/09/2020","study_txt":" Completion: 06/09/2020","study_completion_date":" 06/09/2020","last_update_posted":"2024-06-14"},{"id":"60729fe2-47ea-41ef-9371-7af88e4f8d8f","acronym":"Spotlight","url":"https://clinicaltrials.gov/study/NCT03504397","created_at":"2021-01-18T17:15:08.157Z","updated_at":"2024-07-02T16:34:27.058Z","phase":"Phase 3","brief_title":"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","source_id_and_acronym":"NCT03504397 - Spotlight","lead_sponsor":"Astellas Pharma Global Development, Inc.","biomarkers":" HER-2 • CLDN18","pipe":" | ","alterations":" HER-2 negative • CLDN18.2 expression","tags":["HER-2 • CLDN18"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e HER-2 negative • CLDN18.2 expression"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e 5-fluorouracil • oxaliplatin • leucovorin calcium • Vyloy (zolbetuximab-clzb)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 566","initiation":"Initiation: 06/21/2018","start_date":" 06/21/2018","primary_txt":" Primary completion: 09/09/2022","primary_completion_date":" 09/09/2022","study_txt":" Completion: 03/31/2025","study_completion_date":" 03/31/2025","last_update_posted":"2024-06-11"},{"id":"493a92fd-ee54-4c1e-bd3b-4ae5fd713f00","acronym":"","url":"https://clinicaltrials.gov/study/NCT06048081","created_at":"2023-09-21T14:10:45.559Z","updated_at":"2024-07-02T16:35:01.780Z","phase":"","brief_title":"Early Access Program for Zolbetuximab","source_id_and_acronym":"NCT06048081","lead_sponsor":"Astellas Pharma Global Development, Inc.","biomarkers":" HER-2 • CLDN18","pipe":" | ","alterations":" HER-2 negative","tags":["HER-2 • CLDN18"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e HER-2 negative"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e 5-fluorouracil • oxaliplatin • leucovorin calcium • Vyloy (zolbetuximab-clzb)"],"overall_status":"Available","enrollment":"","initiation":"","start_date":"","primary_txt":"","primary_completion_date":"","study_txt":"","study_completion_date":"","last_update_posted":"2024-05-23"},{"id":"3e226359-22ea-4183-8dc4-9749caa27d32","acronym":"GLOW","url":"https://clinicaltrials.gov/study/NCT03653507","created_at":"2021-01-18T17:55:46.907Z","updated_at":"2024-07-02T16:35:03.022Z","phase":"Phase 3","brief_title":"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","source_id_and_acronym":"NCT03653507 - GLOW","lead_sponsor":"Astellas Pharma Global Development, Inc.","biomarkers":" HER-2 • CLDN18","pipe":" | ","alterations":" HER-2 negative • CLDN18.2 expression","tags":["HER-2 • CLDN18"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e HER-2 negative • CLDN18.2 expression"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e capecitabine • oxaliplatin • Vyloy (zolbetuximab-clzb)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 507","initiation":"Initiation: 11/28/2018","start_date":" 11/28/2018","primary_txt":" Primary completion: 10/25/2022","primary_completion_date":" 10/25/2022","study_txt":" Completion: 03/31/2025","study_completion_date":" 03/31/2025","last_update_posted":"2024-05-17"},{"id":"2f2a89e1-3f78-4f28-8767-c134a39deb5d","acronym":"ILUSTRO","url":"https://clinicaltrials.gov/study/NCT03505320","created_at":"2021-01-18T17:15:25.042Z","updated_at":"2024-07-02T16:35:04.695Z","phase":"Phase 2","brief_title":"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","source_id_and_acronym":"NCT03505320 - 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FAST","lead_sponsor":"Astellas Pharma Global Development, Inc.","biomarkers":" HER-2 • CLDN18","pipe":" | ","alterations":" HER-2 negative • CLDN18.2 expression","tags":["HER-2 • CLDN18"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e HER-2 negative • CLDN18.2 expression"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e capecitabine • oxaliplatin • epirubicin • Vyloy (zolbetuximab-clzb)"],"overall_status":"Completed","enrollment":" Enrollment 252","initiation":"Initiation: 07/19/2012","start_date":" 07/19/2012","primary_txt":" Primary completion: 01/31/2019","primary_completion_date":" 01/31/2019","study_txt":" Completion: 01/31/2019","study_completion_date":" 01/31/2019","last_update_posted":"2020-01-18"},{"id":"c34a35a5-32f3-4d5e-8a43-5cb81135448b","acronym":"","url":"https://clinicaltrials.gov/study/NCT01671774","created_at":"2021-03-09T08:55:20.043Z","updated_at":"2024-07-02T16:36:54.467Z","phase":"Phase 1","brief_title":"Safety and Activity of IMAB362 in Combination With Zoledronic Acid and Interleukin-2 in CLDN18.2-positive Gastric Cancer","source_id_and_acronym":"NCT01671774","lead_sponsor":"Astellas Pharma Global Development, Inc.","biomarkers":" CLDN18","pipe":" | ","alterations":" CLDN18.2 expression","tags":["CLDN18"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e CLDN18.2 expression"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Vyloy (zolbetuximab-clzb) • zoledronic acid"],"overall_status":"Completed","enrollment":" Enrollment 32","initiation":"Initiation: 10/16/2012","start_date":" 10/16/2012","primary_txt":" Primary completion: 10/13/2014","primary_completion_date":" 10/13/2014","study_txt":" Completion: 10/13/2014","study_completion_date":" 10/13/2014","last_update_posted":"2019-10-18"},{"id":"1664127f-d902-4665-9fc2-2ed2637151b0","acronym":"","url":"https://clinicaltrials.gov/study/NCT00909025","created_at":"2021-03-09T08:53:50.437Z","updated_at":"2024-07-02T16:37:20.393Z","phase":"Phase 1","brief_title":"Safety and Tolerability Study of Claudiximab in Patients With Advanced Gastroesophageal Cancer","source_id_and_acronym":"NCT00909025","lead_sponsor":"Ganymed Pharmaceuticals GmbH","biomarkers":" CLDN18","pipe":" | ","alterations":" CLDN18.2 expression","tags":["CLDN18"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e CLDN18.2 expression"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Vyloy (zolbetuximab-clzb)"],"overall_status":"Completed","enrollment":" Enrollment 15","initiation":"Initiation: 05/01/2009","start_date":" 05/01/2009","primary_txt":" Primary completion: 05/01/2010","primary_completion_date":" 05/01/2010","study_txt":" Completion: 05/01/2010","study_completion_date":" 05/01/2010","last_update_posted":"2017-07-02"},{"id":"2e4e0216-e3d2-4227-a705-162d410a2195","acronym":"","url":"https://clinicaltrials.gov/study/NCT01197885","created_at":"2021-03-09T08:54:24.735Z","updated_at":"2024-07-02T16:37:20.403Z","phase":"Phase 2","brief_title":"Efficacy and Safety Study of Multiple Doses of IMAB362 in Patients With Advanced Gastroesophageal Cancer","source_id_and_acronym":"NCT01197885","lead_sponsor":"Ganymed Pharmaceuticals GmbH","biomarkers":" CLDN18","pipe":" | ","alterations":" CLDN18.2 expression","tags":["CLDN18"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e CLDN18.2 expression"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Vyloy (zolbetuximab-clzb)"],"overall_status":"Completed","enrollment":" Enrollment 54","initiation":"Initiation: 09/01/2010","start_date":" 09/01/2010","primary_txt":" Primary completion: 08/01/2015","primary_completion_date":" 08/01/2015","study_txt":" Completion: 08/01/2015","study_completion_date":" 08/01/2015","last_update_posted":"2017-07-02"}]