Status:
RECRUITING
ASKB589 in Combination With CAPOX and PD-1 Inhibitor in Patients With Advanced or Metastatic GC/GEJ Adenocarcinoma
Lead Sponsor:
AskGene Pharma, Inc.
Collaborating Sponsors:
Jiangsu Aosaikang Pharmaceutical Co., Ltd.
Conditions:
Gastroesophageal Junction Adenocarcinoma
Gastric Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 CA...
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 CA...
Eligibility Criteria
Inclusion
- Histologically confirmed adenocarcinoma of gastric and gastroesophageal junction
- Advanced recurrent or metastatic disease confirmed by imaging within 28 days prior to randomization
- Suitable for chemotherapy combined with PD-1 inhibitor
- Not suitable for anti-HER2 therapy
- Have at least one measurable lesion according to RECIST1.1 assessed by site investigator within 28 days prior to randomization
- CLDN 18.2 positive
Exclusion
- Patients with active central nervous system (CNS) metastases or suspected carcinomatous meningitis
- Participants have significant gastric bleeding
- The presence of clinically uncontrollable third interspace fluid
- Received anti-CLDN18.2 antibody at any time in the past
- Suspected complete or partial obstruction of gastroesophageal access
Key Trial Info
Start Date :
January 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2028
Estimated Enrollment :
780 Patients enrolled
Trial Details
Trial ID
NCT06206733
Start Date
January 25 2024
End Date
December 30 2028
Last Update
March 25 2024
Active Locations (1)
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1
Beijing cancer hospital
Beijing, China