Status:
UNKNOWN
Study of KN026 in Combination With Docetaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
Lead Sponsor:
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
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.
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
August 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 15 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04881929
Start Date
August 9 2021
End Date
February 15 2023
Last Update
June 22 2022
Active Locations (1)
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1
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China, 200000