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

Sponsor
European Institute of Oncology
Study ID
NCT07427992
Status
Recruiting
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Conditions

  • Gastric Adenocarcinoma
  • Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Study Details

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 Dates

First listed
Feb 23, 2026
Start date
Jun 20, 2025
Status verified
Jul 2025
Primary completion
Dec 30, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
70 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Progression-free survival [ Time Frame: 2 years ]

Central Contacts

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