Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries.
Hyuna Sung, Jacques Ferlay, Rebecca L Siegel...
https://pubmed.ncbi.nlm.nih.gov/33538338Actively Recruiting
Age: 19Years +
All Genders
ID06767449
Study on Zolbetuximab Plus Chemotherapy in Claudin18.2 Positive, HER2 Negative Advanced Gastric Cancer A Multi-center Observational Study Evaluating Real-world Treatment Effectiveness and Safety
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
Researchers are evaluating the real-world effectiveness and safety of zolbetuximab combined with chemotherapy in patients with advanced gastric cancer that is positive for Claudin18.2 and negative for HER2. This study focuses on outcomes such as progression-free survival, overall survival, and response rates while also monitoring adverse effects according to the NCI CTCAE version 5.0. Tissue and blood samples will be collected to explore molecular markers related to treatment response. Participants receive zolbetuximab as a first-line treatment, and tissue samples are collected before treatment, during treatment, and at disease progression. These samples undergo multiplex immunohistochemistry to assess PD-L1 expression, MMR gene status, and Claudin18.2 levels, along with next-generation sequencing to examine correlations with treatment outcomes. Blood samples are also taken throughout the treatment period and after completion to analyze circulating tumor DNA, single-cell RNA sequencing, and immune cell profiling. During the study, participants will be monitored over two years to assess treatment effectiveness and document any treatment-related adverse events. The study also involves detailed molecular marker analyses from collected tissue and blood samples. Researchers will use these data to better understand how zolbetuximab works in this patient population and to evaluate its safety profile over time.
CONDITIONS
Official Title
Zolbetuximab Claudin18.2 Positive, HER2 Negative, Advanced Gastric Cancer
Who Can Participate
Age: 19Years +
All Genders
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
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1
2
3
Trial Site Locations
Total: 1 location
1
Severance Hospital
Seoul, South Korea, 03722
Actively Recruiting
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Research Team
S
Sun Young Rha
M
minkyu Jung
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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Published Research Related To This Trial
claudin-18, a novel downstream target gene for the T/EBP/NKX2.1 homeodomain transcription factor, encodes lung- and stomach-specific isoforms through alternative splicing.
T Niimi, K Nagashima, J M Ward...
https://pubmed.ncbi.nlm.nih.gov/11585919Claudins and the modulation of tight junction permeability.
Dorothee Günzel, Alan S L Yu
https://pubmed.ncbi.nlm.nih.gov/23589827Claudin-18 splice variant 2 is a pan-cancer target suitable for therapeutic antibody development.
Ugur Sahin, Michael Koslowski, Karl Dhaene...
https://pubmed.ncbi.nlm.nih.gov/19047087Immunohistochemical analysis of claudin expression in pancreatic cystic tumors.
Jin Ha Lee, Kyung Sik Kim, Tae-Jung Kim...
https://pubmed.ncbi.nlm.nih.gov/21206985Claudin 18.2 is a target for IMAB362 antibody in pancreatic neoplasms.
Stefan Wöll, Anna Melissa Schlitter, Karl Dhaene...
https://pubmed.ncbi.nlm.nih.gov/23900716Immunohistochemical study of claudin 18 involvement in intestinal differentiation during the progression of intraductal papillary mucinous neoplasm.
Yuichi Sanada, Yoshinobu Hirose, Shinji Osada...
https://pubmed.ncbi.nlm.nih.gov/20683045New markers of pancreatic cancer identified through differential gene expression analyses: claudin 18 and annexin A8.
Zarir E Karanjawala, Peter B Illei, Raheela Ashfaq...
https://pubmed.ncbi.nlm.nih.gov/18223320Zolbetuximab plus CAPOX in CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma: the randomized, phase 3 GLOW trial.
Manish A Shah, Kohei Shitara, Jaffer A Ajani...
https://pubmed.ncbi.nlm.nih.gov/37524953Zolbetuximab plus mFOLFOX6 in patients with CLDN18.2-positive, HER2-negative, untreated, locally advanced unresectable or metastatic gastric or gastro-oesophageal junction adenocarcinoma (SPOTLIGHT): a multicentre, randomised, double-blind, phase 3 trial.
Kohei Shitara, Florian Lordick, Yung-Jue Bang...
https://pubmed.ncbi.nlm.nih.gov/37068504