NCT04165993

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

Phase II Study of Efficacy and Safety Evaluation of KN026 Monotherapy or Combination Therapy in Patients With HER2 Expressing or Positive Metastatic Breast Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Concurrent chemotherapy and KN026	30 mg/kg Q3W KN026 75 mg/m2 docetaxol
DRUG	KN026 monotherapy	30 mg/kg Q3W KN026
DRUG	KN026 combination	30 mg/kg Q3W KN026 5 mg/kg Q3W KN046

Timeline

• Start date: 2019-12-31
• Primary completion: 2021-05-27
• Completion: 2025-12-31
• First posted: 2019-11-18
• Last updated: 2023-09-21

Locations

1 site across 1 country: China