Clinical Study of Recombinant Anti-HER2 Humanized Monoclonal Antibody (GB221) for Injection
Status:
Unknown status
Trial end date:
2020-11-01
Target enrollment:
Participant gender:
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.