Ignite Creation Date:
2024-05-06 @ 7:25 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06000033
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-08-21
First Post:
2023-08-14
Brief Title:
Study of Disitamab Vedotin and Anlotinib in Patients With HR-Negative HER2-Low-Expressing Metastatic Breast Cancer
Sponsor:
Qilu Hospital of Shandong University
Organization:
Qilu Hospital of Shandong University
Study Overview
Official Title:
Combination of Disitamab Vedotin and Anlotinib in the Treatment of HR-Negative HER2-Low-Expressing Metastatic Breast Cancer A Single-Arm Multicenter Phase II Clinical Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
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:
Disitamab Vedotin RC48 contains the novel humanized anti-HER2 antibody conjugated to monomethyl auristatin E MMAE via a cleavable linker which is the first ADC drug that was independently developed by Rongchang Biology The aim of this study is to evaluate the efficacy and safety of RC48 in Combination with Anlotinib for the treatment of metastatic breast cancer with HR negativity and HER2 low expression
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None