Clinical Study of Recombinant Anti-HER2 Humanized Monoclonal Antibody (GB221) for Injection

Summary

The primary objective of this trial is to compare the progression-free survival (PFS) in two groups of combined therapy of GB221/ capecitabine tablets versus combined therapy of placebo/capecitabine tablets; the secondary objective is to evaluate the objective response rate (ORR),time to progression (TTP) from treatment period to week 12; overall survival (OS), safety, immunogenicity (anti-drug antibody), PFS of subjects during continued treatment period.

Timeline

Start

2016-11-24

Primary completion

2020-07

Completion

2020-11

Drugs

Indications