Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 7:42 PM
Study NCT ID:
NCT07427992
Status:
RECRUITING
Last Update Posted:
2026-02-23
First Post:
2026-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real-WorlD ZolbetUximab in Patients With HER-2 Negative and CLaudin 18.2 PosItive MetastatiC AdEnocarcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-17', 'studyFirstSubmitDate': '2026-02-17', 'studyFirstSubmitQcDate': '2026-02-17', 'lastUpdatePostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': '2 years', 'description': 'The primary endpoint of this one-arm observational study is progression-free survival'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['claudin', 'real world study', 'Gastric Adenocarcinoma', 'zolbetuximab', 'gastroesophageal junction adenocarcinoma'], 'conditions': ['Gastric Adenocarcinoma', 'Gastroesophageal Junction Adenocarcinoma']}, 'referencesModule': {'references': [{'pmid': '37524953', 'type': 'BACKGROUND', 'citation': 'Shah MA, Shitara K, Ajani JA, Bang YJ, Enzinger P, Ilson D, Lordick F, Van Cutsem E, Gallego Plazas J, Huang J, Shen L, Oh SC, Sunpaweravong P, Soo Hoo HF, Turk HM, Oh M, Park JW, Moran D, Bhattacharya P, Arozullah A, Xu RH. Zolbetuximab plus CAPOX in CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma: the randomized, phase 3 GLOW trial. Nat Med. 2023 Aug;29(8):2133-2141. doi: 10.1038/s41591-023-02465-7. Epub 2023 Jul 31.'}, {'pmid': '37068504', 'type': 'RESULT', 'citation': 'Shitara K, Lordick F, Bang YJ, Enzinger P, Ilson D, Shah MA, Van Cutsem E, Xu RH, Aprile G, Xu J, Chao J, Pazo-Cid R, Kang YK, Yang J, Moran D, Bhattacharya P, Arozullah A, Park JW, Oh M, Ajani JA. Zolbetuximab plus mFOLFOX6 in patients with CLDN18.2-positive, HER2-negative, untreated, locally advanced unresectable or metastatic gastric or gastro-oesophageal junction adenocarcinoma (SPOTLIGHT): a multicentre, randomised, double-blind, phase 3 trial. Lancet. 2023 May 20;401(10389):1655-1668. doi: 10.1016/S0140-6736(23)00620-7. Epub 2023 Apr 15.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective is to validate, throughout a national real-world study, the efficacy and safety of Zolbetuximab combined with FOLFOX or XELOX regimens. Specific clinical issues will be studied by pre-planned subgroup analyses, addressing practical clinical needs which have not been specifically investigated in randomized clinical trials.', 'detailedDescription': 'Advanced HER-2 negative gastric adenocarcinoma and gastroesophageal junction adenocarcinoma represents an oncological entity with a relatively poor prognosis and limited therapeutic options. Zolbetuximab, marketed as VYLOY, is a monoclonal antibody targeting the Claudin 18.2 protein, a tissue marker highly expressed in around 30 to 40% of GA or GEJA adenocarcinomas.\n\nOn September 20, 2024, the European Medicines Agency approved the use of VYLOY (zolbetuximab) in combination with fluoropyrimidine- and platinum-based chemotherapies as a first-line treatment for adult patients with locally advanced unresectable or metastatic HER2-negative and Claudin 18.2 positive gastric or gastroesophageal junction adenocarcinoma.\n\nThis approval is based on two positive phase III randomized clinical trials, SPOTLIGHT and GLOW, which demonstrated the efficacy of Zolbetuximab in this clinical context.\n\nIn October 2024, following this approval, an Early Access Program (EAP) was launched in Italy to provide early access to eligible patients for this treatment. (ClinicalTrials.gov ID NCT06048081) This national-scale prospective real-world observational study aims to validate the efficacy and safety data of zolbetuximab in combination with fluoropyrimidine- and platinum-based chemotherapies, analyzing specific clinical aspects through pre-planned subgroup analyses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients (≥ 18 years) with advanced HER-2 negative and Claudin 18.2 positive gastric or gastroesophageal junction adenocarcinoma.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with histologically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma.\n* Patient with locally advanced, unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.\n* Patient whose tumor expresses claudin18.2 in ≥ 75% of tumor cells demonstrating moderate to strong membranous CLDN18 staining as determined by local or central immunohistochemistry testing.\n* Patient with a Human epidermal growth factor receptor 2 negative tumor by local testing on a gastric or gastroesophageal junction tumor specimen.\n* Patient with Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n* Patient who can have access to the Zolbetuximab EAP program or locally authorized and reimbursed (AIFA) procedure.\n* Patient who has about to start first-line Zolbetuximab + FOLFOX/XELOX or who has an ongoing Zolbetuximab FOLFOX/XELOX with available clinical data.\n\nExclusion Criteria:\n\n* Patient has previously received treatment in a clinical trial of zolbetuximab, or a clinical trial that included zolbetuximab as 1 of the treatment options, even if the patient was not given zolbetuximab.\n* Patient has known dihydropyrimidine dehydrogenase deficiency.\n* Patient has received prior systemic chemotherapy for locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. However, patient may have received either neoadjuvant or adjuvant chemotherapy, immunotherapy or other systemic anticancer therapies as long as it was completed at least 6 months prior to participation.'}, 'identificationModule': {'nctId': 'NCT07427992', 'acronym': 'DUPLICATE', 'briefTitle': 'Real-WorlD ZolbetUximab in Patients With HER-2 Negative and CLaudin 18.2 PosItive MetastatiC AdEnocarcinoma', 'organization': {'class': 'OTHER', 'fullName': 'European Institute of Oncology'}, 'officialTitle': 'Real-WorlD ZolbetUximab Combined With chemotheraPy in Patients With HER-2 Negative and CLaudin 18.2 PosItive MetastatiC GAsTric or Gastroesophageal Junction AdEnocarcinoma', 'orgStudyIdInfo': {'id': 'L2-356'}, 'secondaryIdInfos': [{'id': 'UID 4835', 'type': 'OTHER', 'domain': 'Clinical Trial Office - Istituto Europeo di oncologia'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'patient with unresectable or metastatic gastric adenocarcinoma.', 'description': 'Adult patients (≥ 18 years) with advanced HER-2 negative and Claudin 18.2 positive gastric or gastroesophageal junction adenocarcinoma treated with Zolbetuximab in combination with fluoropyrimidine- and platinum-based chemotherapies.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20141', 'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Nicola Fazio, MD,PhD', 'role': 'CONTACT', 'email': 'divisione.gastrointestinale@ieo.it', 'phone': '0257489258'}, {'name': 'Nicola Fazio, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Chiara Alessandra Cella, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Lorenzo Gervaso, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Francesca Spada, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Lavinia Benini, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Davide Ciardiello, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'European Institute of Oncology', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'centralContacts': [{'name': 'Chiara Alessandra Cella, MD', 'role': 'CONTACT', 'email': 'divisione.gastrointestinale@ieo.it', 'phone': '00390257489258'}, {'name': 'Lorenzo Gervaso, MD', 'role': 'CONTACT', 'email': 'divisione.gastrointestinale@ieo.it', 'phone': '00390257489258'}], 'overallOfficials': [{'name': 'Nicola Fazio, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'IEO'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Institute of Oncology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}