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

Alphamab

Status and phase: Active, not recruiting; Phase 2

Conditions: Metastatic Breast Cancer

Treatments: Drug: Concurrent chemotherapy and KN026; Drug: KN026 monotherapy; Drug: KN026 combination

Study type: Interventional

Funder types: Industry

Identifiers

NCT04165993

KN026-201

Details and patient eligibility

About

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

Full 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

Enrollment: 68 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 3 patient groups

Concurrent chemotherapy and KN026

Experimental group

Description:

KN026 combined with docetaxol

Treatment:

Drug: Concurrent chemotherapy and KN026

KN026 monotherapy

Experimental group

Description:

KN026 monotherapy

Treatment:

Drug: KN026 monotherapy

A combination treatment of KN026 and KN046

Experimental group

Description:

KN026 combined with KN046

Treatment:

Drug: KN026 combination