Early Access Program for Zolbetuximab

Inclusion Criteria:

• Patient has histologically confirmed diagnosis of gastric or gastroesophagealjunction adenocarcinoma.

• Patient has confirmed locally advanced, unresectable or metastatic gastric or GEJadenocarcinoma.

• Patient whose tumor expresses claudin18.2 (CLDN18.2) in ≥ 75% of tumor cellsdemonstrating moderate to strong membranous CLDN18 staining as determined by localor central immunohistochemistry (IHC) testing.

• Patient has a Human epidermal growth factor receptor 2 (HER2-negative) tumor bylocal testing on a gastric or GEJ tumor specimen.

• Patient has Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

• Patient must meet all of the following criteria based on the locally analyzedlaboratory tests collected.

• Hemoglobin (Hgb) ≥ 9 g/dL. Patients requiring transfusions are eligible if theyhave post-transfusion Hgb ≥ 9 g/dL.

• Absolute neutrophil count (ANC) ≥ 1.5 × 109/L

• Platelets ≥ 100 × 109/L

• Albumin ≥ 2.5 g/dL

• Total bilirubin (TBL) ≤ 1.5 × ULN without liver metastases (or < 3.0 × ULN ifliver metastases are present)

• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 ×upper limit of normal (ULN) without liver metastases (or ≤ 5 × ULN if livermetastases are present)

• Estimated creatinine clearance ≥ 30 mL/min

• Prothrombin time/international normalized ratio (PT/INR) and partialthromboplastin time ≤ 1.5 × ULN (except for patients receiving anticoagulationtherapy)

• Female patient is not pregnant and at least 1 of the following conditions apply:

• Not a woman of child bearing potential (WOCBP)

• WOCBP who agrees to follow the contraceptive guidance from the time of informedconsent through at least 9 months after the final administration of oxaliplatinand 6 months after final administration of other interventions.

• Female patient must agree not to breastfeed starting at screening and throughout theEAP period and for 6 months after final intervention administration.

• Female patient must not donate ova starting at first administration of treatment andthroughout the EAP period and for 9 months after the final administration ofoxaliplatin and 6 months after final administration of other interventions.

• Male patient with female partner(s) of childbearing potential (includingbreastfeeding partner) must agree to use contraception throughout the treatmentperiod and for 6 months after final treatment administration.

• Male patient must not donate sperm during the treatment period and for 6 monthsafter final treatment administration.

• Male patient with pregnant partner(s) must agree to remain abstinent or use a condomfor the duration of the pregnancy throughout the EAP period and for 6 months afterfinal treatment administration.

Exclusion Criteria:

• Patient has previously received treatment in a clinical trial of zolbetuximab, or aclinical trial that included zolbetuximab as 1 of the treatment options, even if thepatient was not given zolbetuximab.

• Patient is a candidate for an ongoing clinical trial of zolbetuximab.

• Patient has received any investigational therapy within 28 days or 5 half-livesprior to screening.

• Patient has a known or suspected hypersensitivity to zolbetuximab, other monoclonalantibodies or any components of the formulation used.

• Patient has received prior systemic chemotherapy for locally advanced unresectableor metastatic gastric or GEJ adenocarcinoma. However, patient may have receivedeither neo-adjuvant or adjuvant chemotherapy, immunotherapy or other systemicanticancer therapies as long as it was completed at least 6 months prior toparticipation.

• Patient has received radiotherapy for locally advanced unresectable or metastaticgastric or GEJ adenocarcinoma ≤ 14 days prior to program registration and has notrecovered from any related toxicity.

• Patient receiving treatment with herbal medications that have known antitumoractivity.

• Patient has received systemic immunosuppressive therapy, including systemiccorticosteroids within 14 days prior to registration. Patients using a physiologicreplacement dose of hydrocortisone or its equivalent (defined as up to 30 mg/day ofhydrocortisone or up to 10 mg/day of prednisone), receiving a single dose ofsystemic corticosteroids or receiving systemic corticosteroids as premedication forradiologic imaging contrast use are allowed.

• Patient has a prior severe allergic reaction, known (immediate or delayed) orsuspected hypersensitivity, intolerance or contraindication to zolbetuximab,mFOLFOX6, CAPOX, other monoclonal antibodies or any components of the formulationsused.

• Patient has known dihydropyrimidine dehydrogenase (DPD) deficiency. (NOTE: Screeningfor DPD deficiency should be conducted per local requirements.)

• Patient has a complete gastric outlet syndrome or a partial gastric outlet syndromewith persistent/recurrent vomiting.

• Patient has significant gastric bleeding and/or untreated gastric ulcers that wouldexclude the patient from participation.

• Patient has any other condition, which makes the patient unsuitable to receive ortolerate zolbetuximab.