Clinical trial NCT04165993: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Metastatic Breast Cancer
Lead sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Sponsor class: INDUSTRY
First posted: 2019-11-18
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: Throughout the duration of the study; up to 2 years
measure: Duration of response (DOR)
timeFrame: up to 2 years
Secondary outcomes:
measure: Percentage of participants with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest
timeFrame: Throughout the duration of the study
measure: Progression free survival (PFS) rates
timeFrame: 6 months and 12 months
measure: Overall survival (OS) rates
timeFrame: 6 months and 12 months
measure: durable benefit rate (DBR)
timeFrame: DBR calculated as the proportion of subjects with best overall response of CR, PR, or SD ≥24 weeks
Other outcomes:
Locations:
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
Study officials:
affiliation: The Second Affiliated Hospital of Harbin Medical University
name: Qingyuan Zhang, Professor
role: PRINCIPAL_INVESTIGATOR
References: