Efficacy and Safety of IMAB362 in Combination With the EOX Regimen for CLDN18.2-positive Gastric Cancer

Inclusion Criteria:

• Histologically confirmed adenocarcinoma of the stomach, the esophagus or thegastroesophageal junction

• Inoperable locally advanced disease or resections with R2 outcome or recurrent ormetastatic disease.

• CLDN18.2 expression confirmed by immunohistochemistry in paraffin embedded tumortissue sample.

• Measurable and/or non-measurable disease as defined according to RECISTv1.1

• Age ≥ 18 years

• Written Informed Consent Form

• ECOG performance status (PS) 0-1

• Life expectancy > 3 months

• HER2/neu negative patients and patients with HER2/neu positive status but noteligible to trastuzumab therapy in discretion of the investigator.

• Adequate cardiac, hepatic, renal, hematologic function.

Exclusion Criteria:

• Prior severe allergic reaction or intolerance to a monoclonal antibody, to thechemotherapeutics used in this study or any excipient in the respectiveformulations.

• Previous chemotherapy for advanced disease.

• Previous perioperative chemotherapy with curative intention within 6 months of startof study treatment. If interval is longer than 6 months (counted from the stop dateof the perioperative chemotherapy), patients are allowed.

• Known HIV infection or known symptomatic hepatitis (A, B, C).

• Symptomatic cerebral metastases.

• Pregnancy or breastfeeding.

• Previous treatments with maximum cumulative doses of epirubicin > 500 mg/m² and/orother anthracyclines and anthracenediones.

• Known dihydropyrimidine dehydrogenase (DPD) deficiency.