NCT05417230

RC48-ADC Combinatioed Envolizumab in Locally Advanced or Metastatic Biliary Tract Cancer With Positive HER-2

RC48-ADC in Combination With Envolizumab for the First-line Treatment of Locally Advanced or Metastatic Biliary Tract Cancer With Positive HER-2: A Prospective, Single-arm Phase II Trial.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (estimated)
• Sponsor: Jiangsu Cancer Institute & Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study was a prospective, single-arm phase II clinical trial to observe and evaluate the efficacy and safety of RC48-ADC combined envafolimab in the first-line treatment of locally advanced or metastatic biliary tract cancer with positive HER-2.

Conditions

• Biliary Tract Cancer

Interventions

Type	Name	Description
DRUG	RC48-ADC	2.5mg/kg, IV, d1, every 2 weeks;
DRUG	Envafolimab	200mg, SC, d1, every 2 weeks;

Timeline

• Start date: 2022-08-01
• Primary completion: 2024-08-01
• Completion: 2025-08-01
• First posted: 2022-06-14
• Last updated: 2022-06-14