NCT04778982

Study of KN026 in Combination With Palbociclib and Fulvestrant in Patients With Advanced Breast Cancer

A Phase II Study to Evaluate Efficacy, Safety and Tolerability of KN026 in Combination With Palbociclib and Fulvestrant in Patients With Locally Advanced HER2-positive Breast Cancer

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 4 (actual)
• Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multicenter, dose-escalation and parallel-group expansion Phase II clinical trial to evaluate the efficacy, safety and tolerability of KN026 in combination with palbociclib and fulvestrant in women or male with HER2-positive metastatic breast cancer .The subjects will receive 20 mg/kg IV Q2W+ palbociclib 100/125 mg/day orally+/-Fulvestrant 500 mg IM until progressive disease, unacceptable toxicity or death.

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.

Conditions

• HER2-positive Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	KN026 combined with Palbociclib and Fulvestrant	HR+/HER2-positive MBC will be treated by KN026 20 mg/kg+Palbociclib+fulvestrant 500 mg

Timeline

• Start date: 2022-05-25
• Primary completion: 2023-03-15
• Completion: 2023-03-15
• First posted: 2021-03-03
• Last updated: 2023-07-17

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study