A Study of Zolbetuximab Together With Pembrolizumab and Chemotherapy in Adults With Gastric Cancer

Zolbetuximab is being studied in people with cancer in and around the stomach or where the food pipe (esophagus) joins the stomach, called gastroesophageal junction (GEJ) cancer. Zolbetuximab with chemotherapy may be used to treat stomach and GEJ cancer when the cancer cells do not have a protein called HER2 (human epidermal growth factor receptor 2) on their surface (HER2-negative) but do have a protein called Claudin 18.2 (Claudin 18.2-positive). Zolbetuximab is thought to work by attaching to the Claudin 18.2 protein in their tumor, which switches on the body's immune system to attack the t

Trial Details

NCT ID
NCT06901531
Phase
PHASE3
Sponsor
Astellas Pharma Global Development, Inc.
Status
RECRUITING
Cancer Type
Gastric Cancer
Interventions
  • zolbetuximab
  • Pembrolizumab
  • Capecitabine
  • Oxaliplatin
  • Folinic acid (leucovorin or local equivalent)
  • 5-fluorouracil (5-FU)
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Bakersfield, California, United States|35.37329,-119.01871
  • Cerritos, California, United States|33.85835,-118.06479
  • La Jolla, California, United States|32.84727,-117.2742
  • Los Angeles, California, United States|34.05223,-118.24368

Key Eligibility Criteria

  • Participant has histologically confirmed gastric or Gastroesophageal Junction (GEJ) adenocarcinoma.
  • Participant has radiographically confirmed, locally advanced, unresectable or metastatic disease within 28 days prior to randomization.
  • Participant has radiologically evaluable disease (measurable and/or nonmeasurable) according to Response Evaluation Criteria in Solid Tumors (RECIS…
  • Participant has Eastern Cooperative Oncology Group Performance Status (ECOG) performance status 0 to 1.

For full eligibility, visit ClinicalTrials.gov.

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