NCT05785325

RC48-ADC Combined With Bevacizumab in HER2-positive Advanced Colorectal Cancer

RC48-ADC Combined With Bevacizumab in HER2-positive Advanced Colorectal Cancer：a Single-arm, Non-randomized, Single-center Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A phase II clinical study of RC48-ADC combined with Bevacizumab as late-line treatment in patients with HER2-expressed metastatic colorectal cancer. A total of 30 patients are planned to be enrolled.

Detailed description

This is a single-arm, non-randomized, single-center trial. Enroll 30 patients with HER2-expressed metastatic colorectal cancer and failure of standard therapy. Divide into 2 cohorts, including 10 patients with low HER2 expression (IHC 2+/FISH negative) and 20 patients with high HER2 expression (IHC 2+/FISH positive or IHC3+). Administer RC48-ADC intravenously in combination with bevacizumab 5mg/kg once every two weeks. Medication must be discontinued until disease progression, intolerable toxicity, informed consent is withdrawn, or investigator judgment is made. The primary endpoints is objective response rate (ORR), and secondary endpoints are progression-free survival (PFS), overall survival (OS), and adverse effects (AE).

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	RC48-ADC plus Bevacizumab	Administer RC48-ADC intravenously in combination with bevacizumab 5mg/kg once every two weeks.

Timeline

• Start date: 2023-08-20
• Primary completion: 2023-12-01
• Completion: 2024-12-01
• First posted: 2023-03-27
• Last updated: 2023-10-31

Locations

1 site across 1 country: China