KN026 is an anti-HER2 bispecific antibody that can simultaneously bind two non-overlapping epitopes of HER2, leading to a dual HER2 signal blockade.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female subject \>= 18 years;
Histologically or cytologically confirmed HER2-positive breast cancer defined as 3+ determined by validated IHC or positive by in situ hybridization (ISH);
Early-stage (T1c or 2, N1, M0; T2 or 3, N0, M0) or locally advanced (T1c or 2 or 3, N2, M0; T3N1M0; T1c or 2 or 3, N3a or 3b, M0) breast cancer;
Adequate organ function assessed within 7 days prior to first trial treatment;
ECOG score 0 or 1;
Left ventricular ejection fraction (LVEF) ≥ 55% at baseline;
You may not be if
Stage IV (metastatic) breast cancer;
Inflammatory breast cancer;
Previous anti-cancer therapy or radiotherapy for any malignancy;
Major surgery for any reason within 28 days;
History of uncontrolled intercurrent illness;
Other medical conditions that at the discretion of investigator interfere with the requirements of the trial in terms of safety or efficacy evaluation, or treatment compliance;
Clareo Health | Study of KN026 in Combination With Docetaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
