Ignite Creation Date:
2025-12-24 @ 1:35 PM
Ignite Modification Date:
2026-01-01 @ 11:20 AM
Study NCT ID:
NCT04170595
Status:
UNKNOWN
Last Update Posted:
2021-03-03
First Post:
2019-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study of Recombinant Anti-HER2 Humanized Monoclonal Antibody for Injection
Sponsor:
Genor Biopharma Co., Ltd.
Organization:
Study Overview
Official Title:
A Randomized, Multicenter, Phase I/IIa Clinical Study to Evaluate the Tolerability, Safety, Efficacy, Pharmacokinetics and Immunogenicity of GB221 for Injection for the Treatment of HER2-positive Breast Cancer Patients
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A randomized, multicenter, Phase I/IIa clinical study to evaluate the tolerability, safety, efficacy, pharmacokinetics and immunogenicity after single/multiple administration of recombinant anti-HER2 humanized monoclonal antibody for injection for the treatment of HER2-positive breast cancer patients.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: