Early Access Program for Zolbetuximab for Stomach and Gastroesophageal Cancer

Sponsor: Astellas Pharma Global Development, Inc.

Expanded Access
Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06048081

Provider View

This program offers early access to the drug zolbetuximab for patients with stomach or gastroesophageal cancer who have not yet received chemotherapy, immunotherapy, or zolbetuximab, and have tested positive for the claudin18.2 protein. Patients will receive zolbetuximab along with other standard cancer treatments.

Patient Parameters

Program Overview

The program provides zolbetuximab to patients with stomach or gastroesophageal junction cancer who have not been treated with chemotherapy, immunotherapy, or zolbetuximab before. Patients must test positive for the claudin18.2 protein, which is found in some cancer cells. Zolbetuximab is given through an infusion into a vein every three weeks, alongside other cancer treatments. Treatment continues until patients experience side effects, their cancer worsens, they start another treatment, they choose to stop, or they do not return for treatment. Regular clinic visits will monitor for side effects and include medical exams, lab tests, and vital signs checks. After stopping treatment, patients will have a follow-up visit within 7 days and another about 30 days later, which can be done by phone if no health issues are present.

Description

The European Union European Medicines Agency, the United States Food and Drug Administration, and South Korea Pharmaceuticals and Medical Devices Agency have approved zolbetuximab for the treatment of advanced stomach/GEJ cancer in adults. Enrollment is closed in United States, and Germany.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with stomach or gastroesophageal junction cancer.
  • Cancer is advanced, cannot be removed by surgery, or has spread.
  • Cancer cells show the claudin18.2 protein in 75% or more of the cells.
  • Cancer is HER2-negative.
  • Good overall health with a performance status of 0 or 1.
  • Meet specific blood and organ function criteria, including:
    • Hemoglobin level of at least 9 g/dL.
    • Neutrophil count of at least 1.5 x 10^9/L.
    • Platelet count of at least 100 x 10^9/L.
    • Albumin level of at least 2.5 g/dL.
    • Bilirubin level within specified limits.
    • Liver enzymes within specified limits.
    • Kidney function with creatinine clearance of at least 30 mL/min.
    • Blood clotting times within specified limits.
  • Women must not be pregnant and agree to use contraception during and after treatment.
  • Women must not breastfeed during and after treatment.
  • Women must not donate eggs during and after treatment.
  • Men must use contraception and not donate sperm during and after treatment.

Exclusion Criteria

  • Previously participated in a trial involving zolbetuximab.
  • Eligible for another ongoing zolbetuximab trial.
  • Received investigational therapy recently.
  • Allergic to zolbetuximab or similar drugs.
  • Previously treated with chemotherapy for advanced cancer, unless it was completed over 6 months ago.
  • Recently received radiotherapy and not recovered from side effects.
  • Using herbal medications with anti-cancer activity.
  • Recently used systemic immunosuppressive therapy.
  • Severe allergic reactions to study drugs.
  • Known deficiency in dihydropyrimidine dehydrogenase (DPD).
  • Severe gastric outlet syndrome or significant gastric bleeding.
  • Any other condition making treatment unsuitable.

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