Study of KN026 Monotherapy or Combination Therapy in Patients With Metastatic Breast Cancer
Primary Purpose
Metastatic Breast Cancer
Status
Active
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Concurrent chemotherapy and KN026
KN026 monotherapy
KN026 combination
Sponsored by

About this trial
This is an interventional treatment trial for Metastatic Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Male or female subject >= 18 years
- Histologically/cytologically confirmed, locally advanced unresectable or metastatic breast cancer
- ECOG score 0 or 1
- Life expectancy >3 months
- According to the definition of RECIST1.1, the patient has at least one measurable lesion
- Adequate organ function prior to start treatment with KN026
- Able to understand, voluntarily participate and willing to sign the ICF
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 >= 4 weeks, which is no evidence of CNS disease progression; Subjects with spinal cord compression and cancerous meningitis are not eligible
- Pregnant or nursing females;or intend pregnancy within this study period or within 6 monthes after the end of this study
- History of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation
- History of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation
- Cavity effusion (pleural effusion, ascites, pericardial effusion, etc.) are not well controlled, and need locally treatment or repeated drainage
Sites / Locations
- Harbin Medical University Cancer Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Concurrent chemotherapy and KN026
KN026 monotherapy
A combination treatment of KN026 and KN046
Arm Description
KN026 combined with docetaxol
KN026 monotherapy
KN026 combined with KN046
Outcomes
Primary Outcome Measures
Objective response rate (ORR)
Objective response rate (ORR) per RECIST 1.1 criteria according to investigators assessment
Duration of response (DOR)
Duration of response (DOR) per RECIST 1.1 criteria according to investigators assessment
Secondary Outcome Measures
Percentage of participants with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest
AEs, SAEs
Progression free survival (PFS) rates
Progression free survival (PFS) rates
Overall survival (OS) rates
Overall survival (OS) rates
durable benefit rate (DBR)
durable benefit rate (DBR)
Full Information
NCT ID
NCT04165993
First Posted
November 1, 2019
Last Updated
September 18, 2023
Sponsor
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT04165993
Brief Title
Study of KN026 Monotherapy or Combination Therapy in Patients With Metastatic Breast Cancer
Official Title
Phase II Study of Efficacy and Safety Evaluation of KN026 Monotherapy or Combination Therapy in Patients With HER2 Expressing or Positive Metastatic Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 31, 2019 (Actual)
Primary Completion Date
May 27, 2021 (Actual)
Study Completion Date
December 31, 2025 (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
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This is an open-label, three-cohort phase 2 study of KN026 in subjects with advanced breast Cancer.
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.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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Concurrent chemotherapy and KN026
Arm Type
Experimental
Arm Description
KN026 combined with docetaxol
Arm Title
KN026 monotherapy
Arm Type
Experimental
Arm Description
KN026 monotherapy
Arm Title
A combination treatment of KN026 and KN046
Arm Type
Experimental
Arm Description
KN026 combined with KN046
Intervention Type
Drug
Intervention Name(s)
Concurrent chemotherapy and KN026
Other Intervention Name(s)
docetaxol
Intervention Description
30 mg/kg Q3W KN026 75 mg/m2 docetaxol
Intervention Type
Drug
Intervention Name(s)
KN026 monotherapy
Other Intervention Name(s)
KN026
Intervention Description
30 mg/kg Q3W KN026
Intervention Type
Drug
Intervention Name(s)
KN026 combination
Other Intervention Name(s)
KN046
Intervention Description
30 mg/kg Q3W KN026 5 mg/kg Q3W KN046
Primary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
Objective response rate (ORR) per RECIST 1.1 criteria according to investigators assessment
Time Frame
Throughout the duration of the study; up to 2 years
Title
Duration of response (DOR)
Description
Duration of response (DOR) per RECIST 1.1 criteria according to investigators assessment
Time Frame
up to 2 years
Secondary Outcome Measure Information:
Title
Percentage of participants with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest
Description
AEs, SAEs
Time Frame
Throughout the duration of the study
Title
Progression free survival (PFS) rates
Description
Progression free survival (PFS) rates
Time Frame
6 months and 12 months
Title
Overall survival (OS) rates
Description
Overall survival (OS) rates
Time Frame
6 months and 12 months
Title
durable benefit rate (DBR)
Description
durable benefit rate (DBR)
Time Frame
DBR calculated as the proportion of subjects with best overall response of CR, PR, or SD ≥24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female subject >= 18 years
Histologically/cytologically confirmed, locally advanced unresectable or metastatic breast cancer
ECOG score 0 or 1
Life expectancy >3 months
According to the definition of RECIST1.1, the patient has at least one measurable lesion
Adequate organ function prior to start treatment with KN026
Able to understand, voluntarily participate and willing to sign the ICF
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 >= 4 weeks, which is no evidence of CNS disease progression; Subjects with spinal cord compression and cancerous meningitis are not eligible
Pregnant or nursing females;or intend pregnancy within this study period or within 6 monthes after the end of this study
History of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation
History of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation
Cavity effusion (pleural effusion, ascites, pericardial effusion, etc.) are not well controlled, and need locally treatment or repeated drainage
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qingyuan Zhang, Professor
Organizational Affiliation
The Second Affiliated Hospital of Harbin Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
State/Province
Heilongjiang
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of KN026 Monotherapy or Combination Therapy in Patients With Metastatic Breast Cancer
We'll reach out to this number within 24 hrs