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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
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).
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). This study will also evaluate efficacy, physical function, safety, and tolerability of ASKB589, as well as its effects on quality of life. Pharmacokinetics (PK) of ASKB589 and the immunogenicity profile of ASKB589 will be evaluated as well.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Beijing cancer hospital
Beijing, China
Start Date
January 25, 2024
Primary Completion Date
December 30, 2026
Completion Date
December 30, 2028
Last Updated
January 27, 2026
780
ESTIMATED participants
ASKB589
DRUG
Oxaliplatin
DRUG
Capecitabine
DRUG
Tislelizumab
DRUG
Placebo
DRUG
Lead Sponsor
AskGene Pharma, Inc.
Collaborators
NCT04704661
NCT06901531
Data Source & Attribution
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