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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: KN026

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jiong Wu, professor; Phone Number: 13601637369; Email: wujiong1122@vip.sina.com
• Study Contact Backup: Name: Benlong Yang, professor; Phone Number: 13764572123; Email: yblqhdx@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Recruiting
      • Fudan university cancer hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: KN026 + Docetaxel; KN026 30 mg/kg IV + Docetaxel 75/m2 every 3 weeks for four cycles	Drug: KN026; KN026 in Combination With Docetaxel; Other Names: Docetaxel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
tp CR as assessed by local pathologist	total pathological complete response as assessed by local pathologist	up to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bp CR as assessed by local pathologist	breast pathological complete response assessed by local pathologist	up to 12 weeks
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
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

Collaborators and Investigators

• Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd
• Investigators: Principal Investigator: Jiong Wu, professor, Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2021
• Primary Completion (Anticipated): November 15, 2022
• Study Completion (Anticipated): February 15, 2023

Study Registration Dates

• First Submitted: May 6, 2021
• First Submitted That Met QC Criteria: May 6, 2021
• First Posted (Actual): May 11, 2021

Study Record Updates

• Last Update Posted (Actual): June 22, 2022
• Last Update Submitted That Met QC Criteria: June 16, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel
• Other Study ID Numbers: KN026-208

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No