Tokyo, June 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061994) titled 'A Biomarker Exploratory Study of Zolbetuximab-Based Treatment for Gastric Cancer' on June 22.

Study Type: Observational

Primary Sponsor: Institute - National Cancer Center

Condition: Condition - Patients with unresectable advanced or recurrent gastric cancer scheduled to receive zolbetuximab-containing chemotherapy Classification by malignancy - Malignancy Genomic information - YES

Objective: Narrative objectives1 - The aim of this study is to evaluate factors associated with sensitivity and acquired resistance to zolbetuximab-containing systemic chemotherapy in patients with gastric cancer. Gene expression and protein phosphorylation profiles related to cancer cell proliferation and maintenance will be analyzed using blood and tissue samples collected before and after treatment. This study also aims to clarify the molecular heterogeneity of cancer cells and contribute to the development of novel therapeutic strategies. Basic objectives2 - Bio-availability

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1) Patients who have been histologically diagnosed with gastric cancer. 2) Patients whose gastric cancer tumor tissue is confirmed to be CLDN18.2-positive by additional testing, including those who have already been confirmed to be CLDN18.2-positive at another institution prior to referral. 3) Patients who are scheduled to receive, or may potentially receive, anticancer drug therapy using zolbetuximab at the participating institution. 4) Patients aged 18 years or older at the time of informed consent. 5) Patients from whom at least one tumor tissue sample and at least one non-tumor sample can be obtained from the following specimens: Tumor samples: Tumor tissue samples newly collected after consent for this study. Non-tumor samples: Non-tumor tissue samples newly collected for this study and/or peripheral blood samples. If newly collected samples are difficult to obtain or if archived samples are considered useful for analysis, the use of archived samples will be permitted. 6) Patients who have provided written informed consent before study registration after receiving a sufficient explanation of the study. 7) Patients may be enrolled even if they are participating in other clinical trials, including investigational new drug trials. Key exclusion criteria - 1) Patients who are considered unsuitable for enrollment in this study by the attending physician. Target Size - 15

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 03 Month 09 Day Date of IRB - 2025 Year 05 Month 09 Day Anticipated trial start date - 2025 Year 05 Month 09 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070938

Disclaimer: Curated by HT Syndication.