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

NCT07427992 | Recruiting

• 2 other identifiers: L2-356UID 4835
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma

Keywords

claudin; real world study; Gastric Adenocarcinoma; zolbetuximab; gastroesophageal junction adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  The primary endpoint of this one-arm observational study is progression-free survival

  2 years

Study Arms (1)

patient with unresectable or metastatic gastric adenocarcinoma.

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.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (≥ 18 years) with advanced HER-2 negative and Claudin 18.2 positive gastric or gastroesophageal junction adenocarcinoma.

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.

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

European Institute of Oncology

Milan, 20141, Italy

RECRUITING

Related Publications (2)

• 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: 37524953 BACKGROUND

• 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.

  PMID: 37068504 RESULT

Study Officials

• Nicola Fazio, MD

  IEO

  STUDY DIRECTOR

Central Study Contacts

Chiara Alessandra Cella, MD

CONTACT

00390257489258; divisione.gastrointestinale@ieo.it

Lorenzo Gervaso, MD

CONTACT

00390257489258; divisione.gastrointestinale@ieo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2026
• First Posted: February 23, 2026
• Study Start: June 20, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: February 23, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)