UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061994 |
|---|---|
| Receipt number | R000070938 |
| Scientific Title | Phosphoproteomic Analysis to Elucidate Resistance Mechanisms and Identify Novel Therapeutic Targets in Zolbetuximab-Based Treatment for Gastric Cancer |
| Date of disclosure of the study information | 2026/06/22 |
| Last modified on | 2026/06/22 00:08:25 |
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Basic information
Public title
A Biomarker Exploratory Study of Zolbetuximab-Based Treatment for Gastric Cancer
Acronym
A Biomarker Exploratory Study of Zolbetuximab-Based Treatment for Gastric Cancer
Scientific Title
Phosphoproteomic Analysis to Elucidate Resistance Mechanisms and Identify Novel Therapeutic Targets in Zolbetuximab-Based Treatment for Gastric Cancer
Scientific Title:Acronym
Phosphoproteomic Analysis to Elucidate Resistance Mechanisms and Identify Novel Therapeutic Targets in Zolbetuximab-Based Treatment for Gastric Cancer
Region
| Japan |
Condition
Condition
Patients with unresectable advanced or recurrent gastric cancer scheduled to receive zolbetuximab-containing chemotherapy
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Adult |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
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
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Comprehensive phosphoproteomic profiling
Key secondary outcomes
Comprehensive gene expression analysis
Protein profiling of circulating extracellular vesicles in blood
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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 sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Hirokazu |
| Middle name | |
| Last name | Shoji |
Organization
National Cancer Center Japan
Division name
Department of Gastrointestinal Medical Oncology
Zip code
1040045
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
hshouji@ncc.go.jp
Public contact
Name of contact person
| 1st name | Shotaro |
| Middle name | |
| Last name | Yamaguchi |
Organization
National Cancer Center Japan
Division name
Department of Gastrointestinal Medical Oncology
Zip code
1040045
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
Homepage URL
shyamag4@ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Astellas Pharma Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Review Committee of the National Cancer Center
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
Tel
03-3542-2511
irst@ml.res.ncc.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a prospective observational study. No treatment modification for research purposes or additional invasive intervention will be performed as a result of study participation. Patients with Claudin 18.2-positive unresectable advanced or recurrent gastric cancer who receive anticancer drug therapy including zolbetuximab will be included. Within the scope of routine clinical practice, tumor tissue and blood samples will be collected before treatment initiation, approximately two months after treatment initiation, and at the time of tumor progression. Comprehensive phosphoproteomic profiling, comprehensive gene expression analysis, and protein profiling of circulating extracellular vesicles will be performed using the collected samples. Enrollment of study participants is currently ongoing.
Management information
Registered date
| 2026 | Year | 06 | Month | 22 | Day |
Last modified on
| 2026 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070938
