NCT04868162

A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck

An Open-Label, Single Arm, Multi-Center Phase II Clinical Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 116 (estimated)
• Sponsor: Shanghai Miracogen Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG003 and the combination of MRG003 and HX008 in patients with recurrent or metastatic squamous cell carcinoma of head and neck.

Detailed description

The study consists of two stages. In Part A, approximately 60 patients will be enrolled to evaluate the safety and preliminarily efficacy of MRG003 at 2.0 and 2.3 mg/kg, to further explore the optimized dose. In Part B, 30 to 50 patients will be enrolled to evaluate the safety and preliminary efficacy of the combination of MRG003 and HX008.

Conditions

• Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck

Interventions

Type	Name	Description
DRUG	MRG003	On the first day of every 3 weeks, MRG003 will be administered via intravenous infusion at 2.0 mg/kg or 2.3 mg/kg.
DRUG	MRG003+HX008	On the first day of every 3 weeks, MRG003 will be administered via intravenous infusion at 2.0 mg/kg or the recommended dose by SMC; and HX008 will be administered via intravenous infusion at 3.0 mg/kg

Timeline

• Start date: 2021-04-23
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2021-04-30
• Last updated: 2025-07-08

Locations

1 site across 1 country: China