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

Metastatic Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04165993
• Other study ID #: KN026-201
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: December 31, 2019
• Est. completion date: December 31, 2025

Study information

• Verified date: September 2023
• Source: Jiangsu Alphamab Biopharmaceuticals Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 68
• Est. completion date: December 31, 2025
• Est. primary completion date: May 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• Concurrent chemotherapy and KN026
30 mg/kg Q3W KN026 75 mg/m2 docetaxol
• KN026 monotherapy
30 mg/kg Q3W KN026
• KN026 combination
30 mg/kg Q3W KN026 5 mg/kg Q3W KN046

Locations

Country	Name	City	State
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (ORR)	Objective response rate (ORR) per RECIST 1.1 criteria according to investigators assessment	Throughout the duration of the study; up to 2 years
Primary	Duration of response (DOR)	Duration of response (DOR) per RECIST 1.1 criteria according to investigators assessment	up to 2 years
Secondary	Percentage of participants with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest	AEs, SAEs	Throughout the duration of the study
Secondary	Progression free survival (PFS) rates	Progression free survival (PFS) rates	6 months and 12 months
Secondary	Overall survival (OS) rates	Overall survival (OS) rates	6 months and 12 months
Secondary	durable benefit rate (DBR)	durable benefit rate (DBR)	DBR calculated as the proportion of subjects with best overall response of CR, PR, or SD =24 weeks