Metastatic Breast Cancer
Conditions
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
Interventions
DRUGConcurrent chemotherapy and KN026
30 mg/kg Q3W KN026 75 mg/m2 docetaxol
DRUGKN026 monotherapy
30 mg/kg Q3W KN026
30 mg/kg Q3W KN026 5 mg/kg Q3W KN046
Sponsors
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female subject \>= 18 years * Histologically/cytologically confirmed, locally advanced unresectable or metastatic breast cancer * ECOG score 0 or 1 * Life expectancy \>3 months * According to the definition of RECIST1.1, the patient has at least one measurable lesion * Adequate organ function prior to start treatment with KN026 * Able to understand, voluntarily participate and willing to sign the ICF
Exclusion criteria
* Accepted any other anti-tumor drug therapies within 4 weeks before fist dose * Accepted radiotherapy within 4 weeks before enrollment * Subjects are eligible with clinically controlled and stable neurologic function \>= 4 weeks, which is no evidence of CNS disease progression; Subjects with spinal cord compression and cancerous meningitis are not eligible * Pregnant or nursing females；or intend pregnancy within this study period or within 6 monthes after the end of this study * History of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation * History of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation * Cavity effusion (pleural effusion, ascites, pericardial effusion, etc.) are not well controlled, and need locally treatment or repeated drainage
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | Throughout the duration of the study; up to 2 years | Objective response rate (ORR) per RECIST 1.1 criteria according to investigators assessment |
| Duration of response (DOR) | up to 2 years | Duration of response (DOR) per RECIST 1.1 criteria according to investigators assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest | Throughout the duration of the study | AEs, SAEs |
| Progression free survival (PFS) rates | 6 months and 12 months | Progression free survival (PFS) rates |
| Overall survival (OS) rates | 6 months and 12 months | Overall survival (OS) rates |
| durable benefit rate (DBR) | DBR calculated as the proportion of subjects with best overall response of CR, PR, or SD ≥24 weeks | durable benefit rate (DBR) |
Countries
China
Outcome results
None listed