NCT05980481

A Study of RC48-ADC Combination Therapies as First-line Treatment in Advanced Metastatic Gastric Cancer

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

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 201 (estimated)
• Sponsor: RemeGen Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	RC48-ADC（2.5mg/kg）	2.5 mg/kg intravenous infusion every 2 weeks
DRUG	Trastuzumab	First load dose is 8.0mg , then 6.0 mg/kg intravenous infusion every 3 weeks
DRUG	Toripalimab	3.0 mg/kg intravenous infusion every 2 weeks
DRUG	Oxaliplatin（130mg/m2 ）	130mg/m2 intravenous infusion Q3W
DRUG	Capecitabine（1000mg/m2）	1000mg/m2 per os Q3W
DRUG	RC48-ADC（2.0mg/kg）	2.0 mg/kg intravenous infusion every 2 weeks
DRUG	Capecitabine（750mg/m2）	750mg/m2 per os Q3W
DRUG	Oxaliplatin（100mg/m2 ）	100mg/m2 intravenous infusion Q3W

Timeline

• Start date: 2023-08-04
• Primary completion: 2025-07-10
• Completion: 2026-10-10
• First posted: 2023-08-08
• Last updated: 2025-09-29

Locations

1 site across 1 country: China