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
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Claudin 18.2 is a promising therapeutic target overexpressed on the surface of gastric cancer cells. The addition of zolbetuximab, the monoclonal antibody targeting Claudin 18.2 to chemotherapy in two recent Phase 3 studies prolonged survival outcomes, indicating that Claudin 18.2 is a valid target in gastric cancer. Asan Medical Center researchers conducted a study on Claudin 18.2 expression in patients with operable gastric cancer and defined moderate to strong claudin expression in more than 75% of tumor cells as Claudin 18.2 overexpression, which was observed in 46.5% of patients with stage I-III tumors. This suggests that zolbetuximab-based treatment may be possible in patients with LAGC. Therefore, The investigator designed a prospective, multicenter, open-label, Phase Ib/II study to determine the efficacy and safety of zolbetuximab/DOS as neoadjuvant chemotherapy in patients with LAGC.
CONDITIONS
Official 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...
- Patients with newly diagnosed, pathologically confirmed, potentially resectable gastric or gastroesophageal junction adenocarcinoma
- Claudin 18.2 positive expression (VENTANA 43-14A ≥75%)
- Clinical stage T3-4/N0 or T2-4/N+ on CT according to AJCC 8th edition
- No confirmed peritoneal seeding by laparoscopy if suspected by CT
- Signed informed consent form including compliance with protocol
- Age 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 normal organ and bone marrow function as defined by hemoglobin ≥9.0 g/dL, ANC >1.5 x 10^3/mcL, platelet count ≥100 x 10^9/L, serum bilirubin ≤1.5 x ULN, AST/ALT ≤2.5 x ULN, creatinine clearance >40 mL/min
- Evidence of menopause or negative pregnancy test in premenopausal women with specific criteria
- Willingness and ability to comply with study protocol and treatments
You will not qualify if you...
- Received investigational product in another clinical study within 2 weeks prior to participation
- Currently enrolled in another clinical study except observational or follow-up studies
- Receiving concomitant chemotherapy, immunotherapy, biologic, or hormonal therapy not related to cancer treatment
- Major surgery within 28 days prior to zolbetuximab administration
- Presence of distant metastasis including M1 lymph node
- Unable to take oral medication
- Gastric outlet obstruction or severe gastrointestinal bleeding that restricts diet without treatment
- Impaired intestinal absorption including obstruction, chronic inflammatory bowel disease, extended bowel resection, or gastric dumping syndrome
- History of organ transplant
- Uncontrolled intercurrent diseases such as active infection, congestive heart failure with symptoms, uncontrolled hypertension, unstable angina, arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions, mental illness, or social conditions preventing compliance
- History of other primary malignancy except low risk of recurrence with disease-free status for 5 years or cured skin cancer (except melanoma) or in situ carcinoma
- History of active congenital immunodeficiency
- Active infections such as tuberculosis or HIV
- Pregnant or lactating women or persons unwilling to use effective contraception from screening to 90 days after last zolbetuximab dose
- Known allergy or hypersensitivity to the investigational product or its components
AI-Screening
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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
CONTACT
H
Hyung-Don Kim, MD,PhD
CONTACT
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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