Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
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
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
Accepted any other anti-tumor drug therapies within 4 weeks before fist dose
Accepted radiotherapy within 4 weeks before enrollment
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
Clareo Health | Study of KN026 Monotherapy or Combination Therapy in Patients With Metastatic Breast Cancer
