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

Recruiting now

Conditions studied: Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma

In brief

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.

Key facts

Study ID

NCT07427992

Run by

European Institute of Oncology

People needed

70

Starts

2025-06-20

Expected to finish

2027-06-30

Last updated by the study team

2026-02-23

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• European Institute of Oncology — Milan, Italy (enrolling)

Full record on ClinicalTrials.gov

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