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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Concurrent chemotherapy and KN026 | Experimental | KN026 combined with docetaxol |
|
| KN026 monotherapy | Experimental | KN026 monotherapy |
|
| A combination treatment of KN026 and KN046 | Experimental | KN026 combined with KN046 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Concurrent chemotherapy and KN026 | Drug | 30 mg/kg Q3W KN026 75 mg/m2 docetaxol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | Objective response rate (ORR) per RECIST 1.1 criteria according to investigators assessment | 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 | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest | AEs, SAEs | Throughout the duration of the study |
| Progression free survival (PFS) rates |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qingyuan Zhang, Professor | The Second Affiliated Hospital of Harbin Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harbin Medical University Cancer Hospital | Harbin | Heilongjiang | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| KN026 monotherapy | Drug | 30 mg/kg Q3W KN026 |
|
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| KN026 combination | Drug | 30 mg/kg Q3W KN026 5 mg/kg Q3W KN046 |
|
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Progression free survival (PFS) rates
| 6 months and 12 months |
| Overall survival (OS) rates | Overall survival (OS) rates | 6 months and 12 months |
| durable benefit rate (DBR) | durable benefit rate (DBR) | DBR calculated as the proportion of subjects with best overall response of CR, PR, or SD ≥24 weeks |
| D017437 |
| Skin and Connective Tissue Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |