Home › Trials › NCT07427992
Clinical trial Recruiting at 1 site Observational Ages 18 to 100

Zolbetuximab with chemotherapy for HER2-negative, Claudin 18.2–positive metastatic gastric or gastroesophageal junction adenocarcinoma

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

Run by European Institute of Oncology · NCT07427992 · Data updated 2026-11-12

This project will try zolbetuximab together with FOLFOX or XELOX as first-line treatment for adults whose HER2-negative stomach or gastroesophageal junction cancers strongly express Claudin 18.2.

More Gastric Adenocarcinoma trials

Quick facts

Study typeObservational
Ages18 Years to 100 Years
SexAll
Enrollment70 (estimated)
SponsorEuropean Institute of Oncology
Academic / other
Drugs / interventionsZolbetuximab, chemotherapy, immunotherapy
Locations1 site (Milan)
StatusRecruiting
StartedJune 20, 2025
Main results expectedDecember 30, 2026
Study endsJune 30, 2027
Registry record updatedFebruary 23, 2026
Trial IDNCT07427992 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults with histologically confirmed, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma that is HER2-negative, shows ≥75% moderate-to-strong membranous Claudin 18.2 staining, has ECOG 0–1, and can access zolbetuximab through the Early Access Program or local reimbursement are ideal candidates.

Probably not a fit

Patients whose tumors lack significant Claudin 18.2 expression, who are HER2-positive, who have ECOG ≥2, or who have already received prior systemic therapy are unlikely to benefit from this first-line program.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This national prospective real-world observational program will collect efficacy and safety data on adults with locally advanced, unresectable or metastatic HER2-negative, Claudin 18.2–positive gastric or gastroesophageal junction adenocarcinoma treated with zolbetuximab plus fluoropyrimidine/platinum chemotherapy (FOLFOX or XELOX). Eligible patients must have tumors with ≥75% Claudin 18.2 membranous staining and ECOG performance status 0–1 and can be enrolled when starting or already receiving the combination via the Early Access Program or local reimbursement. Pre-planned subgroup analyses will address practical clinical questions not fully explored in randomized trials and compare real-world outcomes with the phase III evidence base. Clinical and safety data will be collected at participating centers with local or central pathology confirmation.

Why it matters

Potential benefit: If successful, this work could confirm that adding zolbetuximab to standard first-line chemotherapy improves outcomes for patients with Claudin 18.2–positive tumors in routine care.

How similar studies have gone: Two phase III randomized trials (SPOTLIGHT and GLOW) demonstrated benefit for zolbetuximab in this setting and led to regulatory approval for first-line use.

Who can join: the full rules

Show full inclusion / exclusion criteria 
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.

Where it's running

  • European Institute of Oncology
    Milan, Italy     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov ↗ Find more trials like this →
Browse more
Gastric Adenocarcinoma 71Gastroesophageal Junction Adenocarcinoma 45Zolbetuximab 6European Institute of Oncology 58
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.