NCT06206733

ASKB589 in Combination With CAPOX and PD-1 Inhibitor in Patients With Advanced or Metastatic GC/GEJ Adenocarcinoma

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 780 (estimated)
• Sponsor: AskGene Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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.

Conditions

• Gastroesophageal Junction Adenocarcinoma
• Gastric Adenocarcinoma

Interventions

Type	Name	Description
DRUG	ASKB589	ASKB589 will be administered as a minimum 3-hour IV infusion
DRUG	Oxaliplatin	Oxaliplatin will be administered as a minimum 2-hour IV infusion
DRUG	Capecitabine	Capecitabine will be administered orally twice daily (bid).
DRUG	Tislelizumab	Tislelizumab will be administered every 3 weeks Intravenous infusion on day 1 of each cycle.
DRUG	Placebo	Placebo will be administered as a minimum 3-hour IV infusion

Timeline

• Start date: 2024-01-25
• Primary completion: 2026-12-30
• Completion: 2028-12-30
• First posted: 2024-01-16
• Last updated: 2026-01-27

Locations

1 site across 1 country: China