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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-31

Study Completion Date

2025-12-31

Brief Summary

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

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Detailed Description

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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

Conditions

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Metastatic Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Concurrent chemotherapy and KN026

KN026 combined with docetaxol

Group Type EXPERIMENTAL

Concurrent chemotherapy and KN026

Intervention Type DRUG

30 mg/kg Q3W KN026 75 mg/m2 docetaxol

KN026 monotherapy

Group Type EXPERIMENTAL

KN026 monotherapy

Intervention Type DRUG

30 mg/kg Q3W KN026

A combination treatment of KN026 and KN046

KN026 combined with KN046

Group Type EXPERIMENTAL

KN026 combination

Intervention Type DRUG

30 mg/kg Q3W KN026 5 mg/kg Q3W KN046

Interventions

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Concurrent chemotherapy and KN026

30 mg/kg Q3W KN026 75 mg/m2 docetaxol

Intervention Type DRUG

KN026 monotherapy

30 mg/kg Q3W KN026

Intervention Type DRUG

KN026 combination

30 mg/kg Q3W KN026 5 mg/kg Q3W KN046

Intervention Type DRUG

Other Intervention Names

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docetaxol KN026 KN046

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No