Phase 2 Study of Ivonescimab with Chemotherapy for Advanced or Metastatic Gastric and Gastroesophageal Adenocarcinoma

What this Trial Is About

Researchers are evaluating the addition of ivonescimab to standard chemotherapy in patients with advanced or metastatic gastric and gastroesophageal adenocarcinoma. This phase 2, multicenter, non-randomized, open-label trial aims to determine whether adding ivonescimab improves the treatment response. The study includes patients with or without specific biomarkers such as HER2, PD-L1, or claudin18.2. Participants receive ivonescimab 20 mgkg by intravenous infusion every two weeks until disease progression. The trial has two groups one receiving FOLFOX chemotherapy combined with ivonescimab and another receiving either paclitaxel or irinotecan combined with ivonescimab per investigator choice. Treatments continue according to protocol schedules until disease progression. Participants visit the clinic every two weeks for treatments, checkups, and tests to monitor adverse events. Researchers assess tumor response using imaging, quality of life questionnaires, and track survival and progression outcomes up to three years. Safety and performance status are also monitored throughout the study and follow-up periods.

Testing Ivonescimab in Combination With Chemotherapy in Advanced or Metastatic Gastric/Gastroesophageal Adenocarcinoma