Actively Recruiting
A Phase Ib/II Trial of Neoadjuvant Zolbetuximab Plus Docetaxel, Oxaliplatin and S-1 Chemotherapy in Patients With Locally Advanced Gastric Cancer
Led by Asan Medical Center · Updated on 2025-07-28
57
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Gastric cancer remains a leading cause of cancer-related death worldwide, with many patients experiencing recurrence after surgery. Researchers are investigating the effectiveness and safety of adding zolbetuximab, a monoclonal antibody targeting Claudin 18.2, to chemotherapy as a neoadjuvant treatment for patients with locally advanced gastric cancer (LAGC). Claudin 18.2 is overexpressed in a significant portion of these tumors, making it a promising target for therapy. This Phase Ib/II open-label study evaluates zolbetuximab combined with docetaxel, oxaliplatin, and S-1 chemotherapy given before surgery. Patients receive three cycles of this neoadjuvant treatment every three weeks, followed by surgical removal of the stomach tumor and lymph node dissection. After surgery, patients receive adjuvant therapy with S-1 and zolbetuximab for up to 12 months to further treat the cancer. Participants will undergo regular assessments including surgery outcomes, tumor response, and survival measures. The main outcomes include the rate of complete tumor removal (R0 resection) and determination of the recommended dose of zolbetuximab. Safety will also be monitored throughout the study. The total participation time includes pre-surgery treatment, surgery, and up to a year of post-surgery therapy, with follow-up evaluations to assess treatment effects and patient health.
CONDITIONS
Brief Title
A Phase Ib/II Trial of Neoadjuvant Zolbetuximab Plus Docetaxel, Oxaliplatin and S-1 Chemotherapy in Patients With Locally Advanced Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed patients with pathologically confirmed, potentially resectable gastric or gastroesophageal junction adenocarcinoma
- Claudin 18.2 positive tumors with expression in at least 75% of tumor cells
- Clinical stage T3-4/N0 or T2-4/N+ on CT scan according to AJCC 8th edition
- No confirmed peritoneal seeding if suspected by CT
- Able to provide signed informed consent
- Aged 19 years or older at study entry
- ECOG performance status of 0 to 1
- Expected survival greater than 12 months
- Weight over 30 kg
- Neuropathy grade 1 or less based on NCI CTCAE v5.0
- Adequate organ and bone marrow function as defined by hemoglobin, neutrophil count, platelet count, liver enzymes, and creatinine clearance
- Evidence of menopause or negative pregnancy test in premenopausal women, with specific age and hormone criteria
- Willing and able to comply with study protocol and treatments
You will not qualify if you...
- Prior investigational product within 2 weeks before participation
- Currently enrolled in another interventional clinical study (except observational or follow-up)
- Receiving concomitant chemotherapy, immunotherapy, biologic, or hormonal therapy unrelated to cancer treatment
- Major surgery within 28 days before zolbetuximab administration
- Presence of distant metastasis including M1 lymph node
- Unable to take oral medication
- Gastric outlet obstruction or severe gastrointestinal bleeding restricting diet without treatment
- Impaired intestinal absorption or history of extensive bowel surgery
- History of organ transplant
- Uncontrolled diseases such as infection, heart failure, hypertension, angina, arrhythmia, lung disease, or serious gastrointestinal conditions
- History of other primary malignancies unless disease-free for at least 5 years or cured of certain skin cancers or in situ carcinoma
- History of active congenital immunodeficiency
- Active infection including tuberculosis or HIV
- Pregnant or lactating women and individuals unwilling to use effective contraception
- Known allergy or hypersensitivity to the investigational product or its components
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 9 weeks
Participants receive zolbetuximab, docetaxel, oxaliplatin, and S-1 chemotherapy every three weeks for three cycles before surgery.
3 visits (in-person) every 3 weeks
Duration - 1 day
Participants undergo total or distal gastrectomy with dissection of the D2 lymph node.
1 hospital stay (in-person)
Duration - 12 months
Starting 3 to 8 weeks after surgery, participants receive S-1 orally plus zolbetuximab every 6 weeks for 12 months as adjuvant therapy.
Biweekly visits during each 6-week cycle, repeated over 12 months
Trial Site Locations
Total: 2 locations
1
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
2
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
Research Team
M
Min-Hee Ryu, MD,PhD
H
Hyung-Don Kim, MD,PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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