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

Breast Cancer Clinical Trial

Official title:

Study of KN026 in Combination With Docetaxel as Neoadjuvant Therapy in Patients With Early-stage or Locally Advanced HER2-positive Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04881929
• Other study ID #: KN026-208
• Status: Recruiting
• Phase: Phase 2
• Start date: August 9, 2021
• Est. completion date: February 15, 2023

Study information

• Verified date: June 2022
• Source: Jiangsu Alphamab Biopharmaceuticals Co., Ltd
• Contact: Benlong Yang, professor
• Phone: 13764572123
• Email: yblqhdx[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 15, 2023
• Est. primary completion date: November 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• KN026
KN026 in Combination With Docetaxel

Locations

Country	Name	City	State
China	Fudan University Cancer Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tp CR as assessed by local pathologist	total pathological complete response as assessed by local pathologist	up to 12 weeks
Secondary	bp CR as assessed by local pathologist	breast pathological complete response assessed by local pathologist	up to 12 weeks
Secondary	ORR as assessed by the investigator according to RECIST 1.1	Objective response rate as assessed by the investigator according to RECIST 1.1	up to 12 weeks
Secondary	safety as assessed by the investigator according to RECIST 1.1	Incidence, type, and severity of adverse events and serious adverse events	up to 12 weeks