Neoplasms

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intravenous infusion

mFOLFOX6 or CAPOX (used at physician discretion) will be used in combination with zolbetuximab

zolbetuximab

Astellas Global Development, Inc.

Medical Director

This program is to provide zolbetuximab to people with stomach cancer or gastroesophageal junction (the junction between stomach and esophagus) cancer who have not yet been treated with chemotherapy, immunotherapy, or zolbetuximab and who have tested positive for claudin18.2 (a protein found in some cancer cells). People will work with their doctor to see if they are capable of being treated with zolbetuximab while they receive other standard medicines to treat their cancer. The program will allow people early access to zolbetuximab before the drug is fully approved.

Zolbetuximab will be given through a vein. This is called an infusion. The infusion will happen during a person's treatment with other cancer medicines. Zolbetuximab will be given every 3 weeks. People will continue treatment until: they have medical problems (unwanted side effects) from the treatment; their cancer gets worse; they start other cancer treatment; they ask to stop treatment; or they do not come back for treatment.

People will visit the clinic on certain days during their treatment. During these visits, the program doctors will check for any medical problems (unwanted side effects) from zolbetuximab, other cancer treatment, or both. At some visits, other checks will include a medical examination, laboratory tests and vital signs. Vital signs include temperature, pulse, and blood pressure. Also, blood samples will be taken.

People will visit the clinic within 7 days after stopping treatment. The program doctors will check for any medical problems (unwanted side effects) from zolbetuximab or their cancer treatment. Other checks will include a medical examination, laboratory tests, and vital signs. Then, people will have a follow-up visit about 30 days after stopping treatment. If people are having no health problems, the follow-up visit can happen over the telephone.

Early Access Program for Zolbetuximab

A Global, Multicenter, Open-label, Early Access Program for Zolbetuximab (IMAB362) Plus mFOLFOX6 or CAPOX in Patients With Claudin18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Astellas Pharma Global Development, Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Early Access Program for Zolbetuximab	NCT06048081	Locally Advance... Locally Advance... Metastatic Gast... Metastatic Gast...	zolbetuximab	18 Years -	Astellas Pharma Inc
Early Access Program for Zolbetuximab	NCT06048081	Locally Advance... Locally Advance... Metastatic Gast... Metastatic Gast...	zolbetuximab	18 Years -	Astellas Pharma Inc
Early Access Program for Zolbetuximab	NCT06048081	Locally Advance... Locally Advance... Metastatic Gast... Metastatic Gast...	zolbetuximab	18 Years -	Astellas Pharma Inc

Spots Global Cancer Trial Database for modified oxaliplatin, folinic acid (leucovorin) and fluorouracim (folfox6)