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ASKB589 in Combination With CAPOX and PD-1 Inhibitor in Patients With Advanced or Metastatic GC/GEJ Adenocarcinoma
Sponsor: AskGene Pharma, Inc.
Summary
This study is a multicenter, randomized, double-blind, standard-of-care controlled phase III clinical study conducted in China. The purpose of this study is to evaluate the efficacy of ASKB589 plus CAPOX and PD-1 inhibitor compared with placebo plus CAPOX and PD-1 inhibitor (as first-line treatment) as measured by Progression Free Survival (PFS).
Official title: A Phase III Study Evaluating the Efficacy and Safety of ASKB589 Combined With CAPOX and PD-1 Inhibitor as First-Line Treatment in Claudin18.2 Positive Patients With Unresectable Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
780
Start Date
2024-01-25
Completion Date
2028-12-30
Last Updated
2026-01-27
Healthy Volunteers
No
Interventions
ASKB589
ASKB589 will be administered as a minimum 3-hour IV infusion
Oxaliplatin
Oxaliplatin will be administered as a minimum 2-hour IV infusion
Capecitabine
Capecitabine will be administered orally twice daily (bid).
Tislelizumab
Tislelizumab will be administered every 3 weeks Intravenous infusion on day 1 of each cycle.
Placebo
Placebo will be administered as a minimum 3-hour IV infusion
Locations (1)
Beijing cancer hospital
Beijing, China