Study of KN026 in Combination With Docetaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer

Alphamab

Status and phase

Enrolling

Phase 2

Conditions

Breast Cancer

Treatments

Drug: KN026

Study type

Interventional

Funder types

Industry

Identifiers

NCT04881929

KN026-208

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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;