Study of KN026 Monotherapy or Combination Therapy in Patients With Metastatic Breast Cancer

Last updated: September 18, 2023
Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Overall Status: Active - Not Recruiting

Phase

2

Condition

Breast Cancer

Metastatic Cancer

Treatment

KN026 monotherapy

Concurrent chemotherapy and KN026

KN026 combination

Clinical Study ID

NCT04165993
KN026-201
  • Ages > 18
  • All Genders

Study Summary

This is an open-label, three-cohort phase 2 study of KN026 in subjects with advanced breast Cancer.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female subject >= 18 years
  • Histologically/cytologically confirmed, locally advanced unresectable or metastaticbreast cancer
  • ECOG score 0 or 1
  • Life expectancy >3 months
  • According to the definition of RECIST1.1, the patient has at least one measurablelesion
  • Adequate organ function prior to start treatment with KN026
  • Able to understand, voluntarily participate and willing to sign the ICF

Exclusion

Exclusion Criteria:

  • Accepted any other anti-tumor drug therapies within 4 weeks before fist dose
  • Accepted radiotherapy within 4 weeks before enrollment
  • Subjects are eligible with clinically controlled and stable neurologic function >= 4weeks, which is no evidence of CNS disease progression; Subjects with spinal cordcompression and cancerous meningitis are not eligible
  • Pregnant or nursing females;or intend pregnancy within this study period or within 6monthes after the end of this study
  • History of immunodeficiency, including HIV positive or other acquired, congenitalimmunodeficiency disease, or a history of organ transplantation
  • History of immunodeficiency, including HIV positive or other acquired, congenitalimmunodeficiency disease, or a history of organ transplantation
  • Cavity effusion (pleural effusion, ascites, pericardial effusion, etc.) are not wellcontrolled, and need locally treatment or repeated drainage

Study Design

Total Participants: 68
Treatment Group(s): 3
Primary Treatment: KN026 monotherapy
Phase: 2
Study Start date:
December 31, 2019
Estimated Completion Date:
December 31, 2025

Study 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.The HER2- positive mBC subjects without systemic treatment will be enrolled in cohort 1 and received 30 mg/kg KN026 and docetaxol. The HER2 low expression and hormone-receptor positive mBC subjects failed standard chemotherapy and hormone therapy will be enrolled in cohort 2 and received 30 mg/kg KN026 monotherapy. The HER2 low expression and hormone-receptor negative/weak positive mBC subjects failed standard chemotherapy will be enrolled in cohort 3 and received 30 mg/kg KN026 and 5 mg/kg KN046

Connect with a study center

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang
    China

    Site Not Available

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