RecruitingNCT06767449

Zolbetuximab Claudin18.2 Positive, HER2 Negative, Advanced Gastric Cancer

Multi-center Cohort Study to Evaluate the Real-world Efficacy and Safety of Zolbetuximab Plus Chemotherapy in Claudin18.2 Positive, HER2 Negative, Advanced Gastric Cancer


Sponsor

Yonsei University

Enrollment

80 participants

Start Date

Dec 1, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

* Treatment effectiveness in the real world * Adverse effects * Tissue samples collected (multiplex IHC to assess PD-L1 expression, MMR gene status, and Claudin18.2) * Blood samples collected (ctDNA, scRNAseq, or immune cell profiling)


Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at the outcomes of patients with advanced stomach or gastroesophageal junction cancer who received zolbetuximab — a drug that targets a protein called Claudin 18.2 — as their first-line treatment. It is an observational study tracking real-world results after patients already received this treatment. **You may be eligible if...** - You are 19 years or older - You have been diagnosed with locally advanced, unresectable, or metastatic gastric or GEJ adenocarcinoma - Your tumor expresses high levels of the Claudin 18.2 protein (in ≥75% of tumor cells, moderate to strong staining) - Your cancer is HER2-negative - You received zolbetuximab as part of your first-line treatment - Your general health is reasonably good (ECOG score 0 or 1) **You may NOT be eligible if...** - Your tumor does not express Claudin 18.2 at sufficient levels - Your tumor is HER2-positive - You have not yet received treatment or received it in a later line Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Severance Hospital

Seoul, South Korea

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NCT06767449


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