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

NCT ID: NCT04881929

Last Updated: 2022-06-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-09
• Study Completion Date: 2023-02-15

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

KN026 + Docetaxel

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

Group Type: EXPERIMENTAL

KN026

Intervention Type: DRUG

KN026 in Combination With Docetaxel

Interventions

KN026

KN026 in Combination With Docetaxel

Intervention Type: DRUG

Other Intervention Names

Docetaxel

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu Alphamab Biopharmaceuticals Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jiong Wu, professor

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Benlong Yang, professor

Role: CONTACT

yblqhdx@163.com

13764572123

Jiong Wu, professor

Role: CONTACT

wujiong1122@vip.sina.com

13601637369

Other Identifiers

KN026-208

Identifier Type: -

Identifier Source: org_study_id