Phase II Study of Efficacy and Safety Evaluation of KN026 Monotherapy or Combination Therapy in Patients With HER2 Expressing or Positive Metastatic Breast Cancer
Overview
- Phase
- Phase 2
- Status
- Active, not recruiting
- Enrollment
- 68
- Locations
- 1
- Primary Endpoint
- Objective response rate (ORR)
Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Concurrent chemotherapy and KN026
KN026 combined with docetaxol
Intervention: Concurrent chemotherapy and KN026 (Drug)
KN026 monotherapy
KN026 monotherapy
Intervention: KN026 monotherapy (Drug)
A combination treatment of KN026 and KN046
KN026 combined with KN046
Intervention: KN026 combination (Drug)
Outcomes
Primary Outcomes
Objective response rate (ORR)
Time Frame: 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)
Time Frame: up to 2 years
Duration of response (DOR) per RECIST 1.1 criteria according to investigators assessment
Secondary Outcomes
- durable benefit rate (DBR)(DBR calculated as the proportion of subjects with best overall response of CR, PR, or SD ≥24 weeks)
- Progression free survival (PFS) rates(6 months and 12 months)
- Percentage of participants with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest(Throughout the duration of the study)
- Overall survival (OS) rates(6 months and 12 months)