Actively Recruiting
Zolbetuximab Claudin18.2 Positive, HER2 Negative, Advanced Gastric Cancer
Led by Yonsei University · Updated on 2025-01-09
80
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
* 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)
CONDITIONS
Official Title
Zolbetuximab Claudin18.2 Positive, HER2 Negative, Advanced Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is 19 years of age or older at the time of consent
- Histologically confirmed locally advanced, unresectable, or metastatic gastric or gastroesophageal junction adenocarcinoma
- Tumor expresses Claudin18.2 in 75% or more of tumor cells with moderate to strong membranous staining by IHC
- Tumor sample is HER2-negative (IHC 0, 1+, or IHC 2+/ISH-)
- Patient has received zolbetuximab as first-line treatment
- ECOG performance status of 0 or 1
- Laboratory test results meet all the following: hemoglobin ≥8 g/dL (≥9 g/dL after transfusion if needed), ANC ≥1.0 x 10^9/L, platelet count ≥75 x 10^9/L, total bilirubin ≤1.5 x ULN without liver metastasis or <3.0 x ULN with liver metastasis, AST or ALT ≤2.5 x ULN without liver metastasis or ≤5 x ULN with liver metastasis, and estimated creatinine clearance ≥30 mL/min
You will not qualify if you...
- Prior participation in a clinical trial involving zolbetuximab, even if zolbetuximab was not administered
- Known or suspected hypersensitivity to zolbetuximab, monoclonal antibodies, or formulation components
- Previous systemic chemotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma, except completed neo-adjuvant or adjuvant chemotherapy, immunotherapy, or other systemic anticancer therapy at least 6 months before enrollment
- Systemic immunosuppressive therapy including corticosteroids within 14 days prior to enrollment, except physiological replacement doses, single corticosteroid dose, or corticosteroids as premedication for contrast agents
- Presence of complete gastric outlet syndrome or partial gastric outlet syndrome with persistent or recurrent vomiting
- Significant gastric bleeding or untreated gastric ulcers deemed exclusionary by the investigator
- Any other condition making the patient unsuitable for zolbetuximab treatment as judged by the treating physician
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Severance Hospital
Seoul, South Korea, 03722
Actively Recruiting
Research Team
S
Sun Young Rha
CONTACT
M
minkyu Jung
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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