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

Sponsor
Jiangsu Alphamab Biopharmaceuticals Co., Ltd (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04881929
Collaborator
(none)
30
1
1
18.2
1.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Study of KN026 in Combination With Docetaxel as Neoadjuvant Therapy in Patients With Early-stage or Locally Advanced HER2-positive Breast Cancer
Actual Study Start Date :
Aug 9, 2021
Anticipated Primary Completion Date :
Nov 15, 2022
Anticipated Study Completion Date :
Feb 15, 2023

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. tp CR as assessed by local pathologist [up to 12 weeks]

      total pathological complete response as assessed by local pathologist

    Secondary Outcome Measures

    1. bp CR as assessed by local pathologist [up to 12 weeks]

      breast pathological complete response assessed by local pathologist

    2. 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

    3. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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;

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fudan University Cancer Hospital Shanghai Shanghai China 200000

    Sponsors and Collaborators

    • Jiangsu Alphamab Biopharmaceuticals Co., Ltd

    Investigators

    • Principal Investigator: Jiong Wu, professor, Fudan University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jiangsu Alphamab Biopharmaceuticals Co., Ltd
    ClinicalTrials.gov Identifier:
    NCT04881929
    Other Study ID Numbers:
    • KN026-208
    First Posted:
    May 11, 2021
    Last Update Posted:
    Jun 22, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 22, 2022