NCT06767449

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: —

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)

Detailed description

* Treatment effectiveness in the real world (progression-free survival, overall survival, response rate, etc.) * Adverse effects will be evaluated according to the NCI CTCAE v5.0 * Tissue samples collected before treatment, during treatment, and at disease progression will be analyzed using multiplex IHC to assess PD-L1 expression, MMR gene status, and Claudin18.2. Additionally, NGS testing will be conducted to evaluate the correlation with the treatment response to zolbetuximab. * Blood samples will be collected before treatment, during treatment, and after treatment completion to analyze ctDNA, scRNAseq, or immune cell profiling.

Conditions

• Advanced Gastric Cancer

Timeline

• Start date: 2024-12-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-01-09
• Last updated: 2025-01-09

Locations

1 site across 1 country: South Korea