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NCT06048081

Early Access Program for Zolbetuximab

AVAILABLE Last updated 10 September 2025
What this trial tests

trial testing zolbetuximab in Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma Cancer. Available.

Quick facts

Lead sponsorAstellas Pharma Global Development, Inc.
StatusAVAILABLE
Study typeEXPANDED_ACCESS
Sites140 locations across France, Germany, South Korea, Singapore, United States, Brazil

Drugs / interventions tested

Conditions studied

Sponsor

Astellas Pharma Global Development, Inc. — full company profile →

Who can join

18 and older, any sex, with Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma Cancer or Locally Advanced Unresectable Gastric Adenocarcinoma Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Dark horse target Claudin18.2 opens new battlefield for pancreatic cancer.
    Xu Q, Jia C, Ou Y, Zeng C, et al · · 2024 · cited 7× · PMID 38511141 · DOI 10.3389/fonc.2024.1371421
  2. Claudin18.2 as a Promising Therapeutic Target in Gastric Cancer.
    Poniewierska-Baran A, Plewa P, Żabicka Z, Pawlik A. · · 2025 · cited 4× · PMID 40862764 · DOI 10.3390/cells14161285

Verify or expand the search:

Other trials of zolbetuximab

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Other Astellas Pharma Global Development, Inc. trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06048081.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing