NCT03713372

Safety and Efficacy of SCT200 in Head and Neck Squamous Cell Carcinoma

A Study of Evaluating Recombinant Human Anti-EGFR Monoclonal Antibody (SCT200) for Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma After Failure of Platinum-based Therapy

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Sinocelltech Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of recombinant anti-EGFR monoclonal antibody（SCT200）in patients with Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma after failure of platinum-based therapy.

Detailed description

This open label, single-arm and multicenter phase II study is designed to evaluate Objective Response Rate (ORR) of anti-EGFR monoclonal antibody（SCT200）in Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma after failure of platinum-based therapy.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	Anti-EGFR monoclonal antibody	Initially, 6.0mg/kg of SCT200 will be administered once a week for a maximum of 6 cycles. After 6 cycles, 8.0mg/kg of SCT200 will be administered every two weeks until disease progression.

Timeline

• Start date: 2018-11-28
• Primary completion: 2020-02-11
• Completion: 2020-05-28
• First posted: 2018-10-19
• Last updated: 2020-03-23

Locations

1 site across 1 country: China