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

Phase 2

• Conditions: Breast Cancer
• Interventions: Drug: KN026

• Registration Number: NCT04881929
• Lead Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd

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.

Study Timeline

• Study First Submitted: 2021-05-06
• Study First Submitted QC: 2021-05-06
• Study First Posted: 2021-05-11
• Study Start: 2021-08-09
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-16
• Last Update Posted: 2022-06-22
• Primary Completion: 2022-11-15
• Study Completion: 2023-02-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
KN026 + Docetaxel	KN026	KN026 30 mg/kg IV + Docetaxel 75/m2 every 3 weeks for four cycles

Primary Outcome Measures

Name	Time	Method
tp CR as assessed by local pathologist	up to 12 weeks	total pathological complete response as assessed by local pathologist

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Fudan University Cancer Hospital; 🇨🇳 Shanghai, Shanghai, China