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Clinical Trial Summary

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

Clinical Trial Description

The study consists of two stages. In Part A, approximately 22 patients will be enrolled to evaluate the safety and preliminarily efficacy of MRG003. Based on the initial safety and efficacy data obtained from the Part A, the study design of second stage Part B single-arm study either will be continued or the trail will be terminated. If the Part A data support the continuation of the study, in the second stage, approximately an additional 98 patients will be enrolled to further evaluate the efficacy and safety of MRG003. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT04868162
Study type Interventional
Source Shanghai Miracogen Inc.
Contact Program Director
Phone 86-21-61637960
Email [email protected]
Status Recruiting
Phase Phase 2
Start date April 23, 2021
Completion date September 2023

See also
  Status Clinical Trial Phase
Recruiting NCT02145312 - An Open Label, Single Arm, Multicenter Phase II Study of BYL719 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck Who Failed to Respond to Platinum-based Therapy. Phase 2