NCT04521179

Study of KN026 Combined With KN046 in Patients With Locally Advanced HER2-positive Solid Tumors

A Phase II, Open-Label, Multi-Center Study to Evaluate Efficacy, Safety and Tolerability of KN026 in Combination With KN046 in Patients With Locally Advanced Unresectable or Metastatic HER2-positive Solid Tumors

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 102 (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, phase II，multi-center study to evaluate the efficacy, safety and tolerability of KN026 in combination with KN046 in subjects with HER2-positive solid tumors.

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.KN046 is a PD-L1 - CTLA-4 bispecific antibody. The study composes of two stages. The first stage plans to enroll HER2-positive solid tumors. All subjects will be treated with KN026 at 30 mg/kg Q3W in combination with KN046 at 5 mg/kg Q3W at the first stage.A SMC meeting will decide whether to proceed to the nest stage.

Conditions

• HER2-positive Solid Tumors

Interventions

Type	Name	Description
DRUG	KN026 combination	30 mg/kg Q3W KN026+ 5 mg/kg Q3W KN046

Timeline

• Start date: 2020-12-07
• Primary completion: 2022-01-12
• Completion: 2023-05-22
• First posted: 2020-08-20
• Last updated: 2023-09-21

Locations

1 site across 1 country: China