Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2026-03-02 @ 4:23 PM
Study NCT ID:
NCT04165993
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-09-21
First Post:
2019-11-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of KN026 Monotherapy or Combination Therapy in Patients With Metastatic Breast Cancer
Sponsor:
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Organization:
Study Overview
Official Title:
Phase II Study of Efficacy and Safety Evaluation of KN026 Monotherapy or Combination Therapy in Patients With HER2 Expressing or Positive Metastatic Breast Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-09
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:
This is an open-label, three-cohort phase 2 study of KN026 in subjects with advanced breast Cancer.
Detailed Description:
KN026 is an anti-HER2 bispecific antibody that can simultaneously bind two non-overlapping epitopes of HER2, leading to a dual HER2 signal blockade.The HER2- positive mBC subjects without systemic treatment will be enrolled in cohort 1 and received 30 mg/kg KN026 and docetaxol. The HER2 low expression and hormone-receptor positive mBC subjects failed standard chemotherapy and hormone therapy will be enrolled in cohort 2 and received 30 mg/kg KN026 monotherapy. The HER2 low expression and hormone-receptor negative/weak positive mBC subjects failed standard chemotherapy will be enrolled in cohort 3 and received 30 mg/kg KN026 and 5 mg/kg KN046
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?: