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NCT07427992Recruiting

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

Real-WorlD ZolbetUximab Combined With chemotheraPy in Patients With HER-2 Negative and CLaudin 18.2 PosItive MetastatiC GAsTric or Gastroesophageal Junction AdEnocarcinoma

Source: ClinicalTrials.gov · Last updated 23 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
70 (estimated)
First submitted
17 Feb 2026
Start date
20 Jun 2025
Primary completion date
30 Dec 2026
Lead sponsor
European Institute of Oncology
NCT number
NCT07427992

What you commit to

  • Study type: Observational
  • Planned participants: 70
  • From 20 Jun 2025 to the primary completion date, 30 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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 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.

Other

  • Patient has known dihydropyrimidine dehydrogenase deficiency.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
European Institute of Oncology
Coordinator of this site? Confirm its status
MilanItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.