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A Study of RC48-ADC Combination Therapies as First-line Treatment in Advanced Metastatic Gastric Cancer
Sponsor: RemeGen Co., Ltd.
Summary
This is a Phase II/III, randomized, multicenter, open-label clinical trial designed to evaluate safety and efficacy of RC48-ADC combine with Toripalimab and chemotherapy or RC48-ADC combine with Toripalimab and Trastuzumab as first-line treatment in human epidermal growth factor receptor 2 (HER2)-expression or non-expression participants with locally advanced or metastatic gastric cancer.
Official title: A Study of RC48-ADC Combine With Toripalimab and Chemotherapy or RC48-ADC Combine With Toripalimab and Trastuzumab as First-line Treatment in Local Advanced or Metastatic Gastric Cancer With the HER2 Expression or Non-expression
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
201
Start Date
2023-08-04
Completion Date
2026-10-10
Last Updated
2025-09-29
Healthy Volunteers
No
Conditions
Interventions
RC48-ADC（2.5mg/kg）
2.5 mg/kg intravenous infusion every 2 weeks
Trastuzumab
First load dose is 8.0mg , then 6.0 mg/kg intravenous infusion every 3 weeks
Toripalimab
3.0 mg/kg intravenous infusion every 2 weeks
Oxaliplatin（130mg/m2 ）
130mg/m2 intravenous infusion Q3W
Capecitabine（1000mg/m2）
1000mg/m2 per os Q3W
RC48-ADC（2.0mg/kg）
2.0 mg/kg intravenous infusion every 2 weeks
Capecitabine（750mg/m2）
750mg/m2 per os Q3W
Oxaliplatin（100mg/m2 ）
100mg/m2 intravenous infusion Q3W
Locations (1)
Beijing Cancer Hospital
Beijing, China