Breast Cancer
Conditions
Brief summary
This is an open-lable, multicenter, and single arm phase II trial to evaluate treatment with KN026 plus docetaxel as neoadjuvant therapy in patients with 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) HER2-positive breast cancer. The subjects will receive KN026 30 mg/kg IV + Docetaxel 75/m2 every 3 weeks for four cycles prior to surgery.
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.
Interventions
DRUGKN026
KN026 in Combination With Docetaxel
Sponsors
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
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 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;
Exclusion criteria
* 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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| tp CR as assessed by local pathologist | up to 12 weeks | total pathological complete response as assessed by local pathologist |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| bp CR as assessed by local pathologist | up to 12 weeks | breast pathological complete response assessed by local pathologist |
| ORR as assessed by the investigator according to RECIST 1.1 | up to 12 weeks | Objective response rate as assessed by the investigator according to RECIST 1.1 |
| safety as assessed by the investigator according to RECIST 1.1 | up to 12 weeks | Incidence, type, and severity of adverse events and serious adverse events |
Countries
China
Contacts
Primary ContactBenlong Yang, professor
Backup ContactJiong Wu, professor
Outcome results
None listed