Early Access Program for Zolbetuximab

Part of paid clinical trials in Morristown, New Jersey.

Sponsor
Astellas Pharma Global Development, Inc.
Study ID
NCT06048081
Status
Available

Conditions

  • Locally Advanced Unresectable Gastric Adenocarcinoma Cancer
  • Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma Cancer
  • Metastatic Gastric Adenocarcinoma Cancer
  • Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • zolbetuximab — DRUG
    intravenous infusion mFOLFOX6 or CAPOX (used at physician discretion) will be used in combination with zolbetuximab

Study Details

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.

Key Dates

Status verified
Sep 2025

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Site US10001MorristownNew Jersey07960-

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