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

Primary Purpose

Breast Cancer

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

KN026

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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;

Sites / Locations

Fudan University Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

KN026 + Docetaxel

Arm Description

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

Outcomes

Primary Outcome Measures

tp CR as assessed by local pathologist

total pathological complete response as assessed by local pathologist

Secondary Outcome Measures

bp CR as assessed by local pathologist

breast pathological complete response assessed by local pathologist

ORR as assessed by the investigator according to RECIST 1.1

Objective response rate as assessed by the investigator according to RECIST 1.1

safety as assessed by the investigator according to RECIST 1.1

Incidence, type, and severity of adverse events and serious adverse events

Full Information

NCT ID

NCT04881929

First Posted

May 6, 2021

Last Updated

June 16, 2022

Sponsor

Jiangsu Alphamab Biopharmaceuticals Co., Ltd

1. Study Identification

Unique Protocol Identification Number

NCT04881929

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Recruiting

Study Start Date

August 9, 2021 (Actual)

Primary Completion Date

November 15, 2022 (Anticipated)

Study Completion Date

February 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jiangsu Alphamab Biopharmaceuticals Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

KN026 + Docetaxel

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

KN026

Other Intervention Name(s)

Docetaxel

Intervention Description

KN026 in Combination With Docetaxel

Primary Outcome Measure Information:

Title

tp CR as assessed by local pathologist

Description

total pathological complete response as assessed by local pathologist

Time Frame

up to 12 weeks

Secondary Outcome Measure Information:

Title

bp CR as assessed by local pathologist

Description

breast pathological complete response assessed by local pathologist

Time Frame

up to 12 weeks

Title

ORR as assessed by the investigator according to RECIST 1.1

Description

Objective response rate as assessed by the investigator according to RECIST 1.1

Time Frame

up to 12 weeks

Title

safety as assessed by the investigator according to RECIST 1.1

Description

Incidence, type, and severity of adverse events and serious adverse events

Time Frame

up to 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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;

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Benlong Yang, professor

Phone

13764572123

yblqhdx@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Jiong Wu, professor

Phone

13601637369

wujiong1122@vip.sina.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jiong Wu, professor

Organizational Affiliation

Fudan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fudan University Cancer Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200000

Country

China

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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