OncoMatch/Clinical Trials/NCT06732856
A Phase Ib/II Trial of Neoadjuvant Zolbetuximab Plus Docetaxel, Oxaliplatin and S-1 Chemotherapy in Patients With Locally Advanced Gastric Cancer
Is NCT06732856 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including zolbetuximab and Oxaliplatin for stomach neoplasm.
Treatment: zolbetuximab · Oxaliplatin · Docetaxel · S-1 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastric Cancer
Biomarker criteria
Required: CLDN18 CLDN18.2 positive (VENTANA 43-14A ≥75%) (VENTANA 43-14A ≥75%)
Subjects who are CLDN18.2 positive (VENTANA 43-14A ≥75%)
Disease stage
Required: Stage T3-4/N0, T2-4/N+ (AJCC 8th edition)
clinical stage T3-4/N0 or T2-4/N+ on CT according to the American Joint Committee on Cancer (AJCC) 8th edition
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: investigational product
Patient who received investigational product in another clinical study 2 weeks prior to participation in this clinical study
Cannot have received: concomitant chemotherapy, immunotherapy, biologic or hormonal therapy
Exception: Hormonal therapies not related to treatment for cancer (e.g., hormone replacement therapy) are allowed.
Concomitant chemotherapy, immunotherapy, biologic or hormonal therapy. Hormonal therapies not related to treatment for cancer (e.g., hormone replacement therapy) are allowed.
Lab requirements
Blood counts
Hemoglobin ≥9.0 g/dL; Absolute neutrophil count (ANC) >1.5 x 10^3/mcL (>1,500 per mm3); Platelet count ≥100 x 10^9/L
Kidney function
Measured creatinine clearance (CL) >40 mL/min or creatinine CL >40 mL/min as calculated by Cockcroft-Gault formula or based on a 24-hour urine sample
Liver function
Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN); AST (SGOT)/ALT (SGPT) ≤2.5 x institutional ULN
Individual with confirmed adequate normal organ and bone marrow function, as defined in the applicable items below: * Hemoglobin ≥9.0 g/dL * Absolute neutrophil count (ANC) >1.5 x 103/mcL (>1,500 per mm3) * Platelet count ≥100 x 109/L * Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN) * AST (SGOT)/ALT (SGPT) ≤2.5 x institutional ULN * Measured creatinine clearance (CL) >40 mL/min or creatinine CL >40 mL/min as calculated by Cockcroft-Gault formula (Cockcroft and Gault 1976) or based on a 24-hour urine sample for determination of creatinine clearance
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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