Phase I Clinical Study of GB222 to Evaluate the Safety, Tolerability and PK Profiles.

Summary

This study is designed to assess the safety and tolerability, pharmacokinetic profiles, immunogenicity of GB222 in Chinese patients with relapsed/progressive high-grade glioma; moreover, changes in cerebral edema, changes in KPS score from baseline, objective response rate (ORR), 4-month progression-free survival (PFS), overall survival (OS)will be evaluated. The dose reduction of hormone during continuous administration period will be observed.

Timeline

Start

2018-10-16

Primary completion

2020-12

Completion

2021-04

Drugs

Indications