NCT05403242

RC48-ADC Combined With S-1 for First-line Treatment of Advanced Gastroesophageal Adenocarcinoma With Moderate Expression of HER2

A Multicenter, Open Label，Single Arm，Phase Ib/II Study to Evaluate the Effect and Safety of RC48-ADC Combined With S-1 for First-line Treatment of Advanced Gastroesophageal Adenocarcinoma With Moderate Expression of HER2

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study was a single-arm, open, multi-center Phase Ib/II clinical trial to observe and evaluate the efficacy and safety of RC48-ADC plus S-1 in first-line treatment of advanced gastroesophageal adenocarcinoma with moderate expression of HER2.

Conditions

• Advanced Gastroesophageal Adenocarcinoma

Interventions

Type	Name	Description
DRUG	RC48-ADC	2.0 mg/kg, IV, d1, every 2 weeks; or 2.5 mg/kg, IV, d1, every 2 weeks
DRUG	S-1	40-60 mg, bid po, d1-10, every 2 weeks

Timeline

• Start date: 2022-09-20
• Primary completion: 2025-09-01
• Completion: 2026-09-01
• First posted: 2022-06-03
• Last updated: 2024-01-08

Locations

3 sites across 1 country: China