Study of KN026 Monotherapy or Combination Therapy in Patients With Metastatic Breast Cancer
- Conditions
- Metastatic Breast Cancer
- Interventions
- Drug: KN026 monotherapyDrug: KN026 combinationDrug: Concurrent chemotherapy and KN026
- Registration Number
- NCT04165993
- Lead Sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., Ltd
- 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
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 68
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description KN026 monotherapy KN026 monotherapy KN026 monotherapy A combination treatment of KN026 and KN046 KN026 combination KN026 combined with KN046 Concurrent chemotherapy and KN026 Concurrent chemotherapy and KN026 KN026 combined with docetaxol
- Primary Outcome Measures
Name Time Method Objective response rate (ORR) Throughout the duration of the study; up to 2 years Objective response rate (ORR) per RECIST 1.1 criteria according to investigators assessment
Duration of response (DOR) up to 2 years Duration of response (DOR) per RECIST 1.1 criteria according to investigators assessment
- Secondary Outcome Measures
Name Time Method durable benefit rate (DBR) DBR calculated as the proportion of subjects with best overall response of CR, PR, or SD ≥24 weeks durable benefit rate (DBR)
Progression free survival (PFS) rates 6 months and 12 months Progression free survival (PFS) rates
Percentage of participants with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest Throughout the duration of the study AEs, SAEs
Overall survival (OS) rates 6 months and 12 months Overall survival (OS) rates
Trial Locations
- Locations (1)
Harbin Medical University Cancer Hospital
🇨🇳Harbin, Heilongjiang, China