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Clinical Trials in Italy / NCT07427992
Recruiting Observational

Real-WorlD ZolbetUximab in Patients With HER-2 Negative and CLaudin 18.2 PosItive MetastatiC AdEnocarcinoma

NCT07427992 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2025-06-20
Last updated
2026-02-23

Condition(s) studied

Gastric AdenocarcinomaGastroesophageal Junction Adenocarcinoma

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
Inclusion Criteria: * Patient with histologically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma. * Patient with locally advanced, unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. * 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. * Patient with a Human epidermal growth factor receptor 2 negative tumor by local testing on a gastric or gastroesophageal junction tumor specimen. * Patient with Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. * Patient who can have access to the Zolbetuximab EAP program or locally authorized and reimbursed (AIFA) procedure. * Patient who has about to start first-line Zolbetuximab + FOLFOX/XELOX or who has an ongoing Zolbetuximab FOLFOX/XELOX with available clinical data. Exclusion Criteria: * 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. * Patient has known dihydropyrimidine dehydrogenase deficiency. * 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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
European Institute of Oncology Milan Italy Recruiting

More European Institute of Oncology trials in Italy

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07427992 on ClinicalTrials.gov ↗ ← All trials in Italy