This is an open-label, three-cohort phase 2 study of KN026 in subjects with advanced breast Cancer.
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
68
30 mg/kg Q3W KN026 75 mg/m2 docetaxol
30 mg/kg Q3W KN026
30 mg/kg Q3W KN026 5 mg/kg Q3W KN046
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Objective response rate (ORR)
Objective response rate (ORR) per RECIST 1.1 criteria according to investigators assessment
Time frame: Throughout the duration of the study; up to 2 years
Duration of response (DOR)
Duration of response (DOR) per RECIST 1.1 criteria according to investigators assessment
Time frame: up to 2 years
Percentage of participants with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest
AEs, SAEs
Time frame: Throughout the duration of the study
Progression free survival (PFS) rates
Progression free survival (PFS) rates
Time frame: 6 months and 12 months
Overall survival (OS) rates
Overall survival (OS) rates
Time frame: 6 months and 12 months
durable benefit rate (DBR)
durable benefit rate (DBR)
Time frame: DBR calculated as the proportion of subjects with best overall response of CR, PR, or SD ≥24 weeks
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