NCT03925974

KN026 in Patients With HER2 Expressing Gastric/Gastroesophageal Junction Cancer

Phase II Study of Evaluating Efficacy, Safety and Tolerance of KN026 in HER2 Expressing Advanced Gastric/Gastroesophageal Junction Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (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 2 study of KN026 in subjects with HER2 expressing gastric/gastroesophageal junction cancer to evaluate efficacy and safety. The subjects will receive KN026 10 mg/kg QW or 20 mg/kg Q2W or 30mg/kg Q3W until progressive disease, unacceptable toxicity or death.

Detailed description

The study consists of two arms as HER2 overexpression arm and HER2 expression arm and both arms will receive KN026 treatment.

Conditions

• Gastric/Gastroesophageal Junction Cancer

Interventions

Type	Name	Description
DRUG	KN026 10 mg/kg QW	10 mg/kg QW as safety run-in dosage
DRUG	KN026 20 mg/kg Q2W	20 mg/kg Q2W as target dosage
DRUG	KN026 30 mg/kg Q3W	30 mg/kg Q3W as another target dosage

Timeline

• Start date: 2019-06-17
• Primary completion: 2022-05-31
• Completion: 2022-05-31
• First posted: 2019-04-24
• Last updated: 2024-03-12

Locations

1 site across 1 country: China