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Recruiting NCT06767449

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

Trial Parameters

Condition Advanced Gastric Cancer
Sponsor Yonsei University
Study Type OBSERVATIONAL
Phase N/A
Enrollment 80
Sex ALL
Min Age 19 Years
Max Age N/A
Start Date 2024-12-01
Completion 2026-12-01

Brief 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 Criteria

Inclusion Criteria: 1. Patient is ≥ 19 years of age at the time of consent. 2. The patient must have histologically confirmed locally advanced, unresectable, or metastatic gastric or gastroesophageal junction adenocarcinoma 3. Patient whose tumor expresses CLDN18.2 in ≥ 75% of tumor cells demonstrating moderate to strong membranous CLDN18 staining as determined by local or central IHC testing. 4. The tumor sample must be HER2-negative (IHC 0, 1+, or IHC 2+/ISH-). 5. The patient must have received Zolbetuximab as a first-line treatment. 6. 1 Patient has ECOG performance status 0 or 1. 7. Patient must meet all of the following criteria based on the locally analyzed laboratory tests collected. * Hb ≥8 g/dL (For patients who require a transfusion, it is appropriate if Hb ≥9 g/dL after transfusion) * ANC ≥1.0 x 10\^9/L * Platelet ≥75 x 10\^9/L * Total bilirubin ≤1.5 x ULN without liver metastasis, or \<3.0 x ULN if liver metastasis is present * AST or ALT ≤2.5 x ULN without liver metastasis

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