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.
The study consists of two arms as HER2 overexpression arm and HER2 expression arm and both arms will receive KN026 treatment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
10 mg/kg QW as safety run-in dosage
20 mg/kg Q2W as target dosage
30 mg/kg Q3W as another target dosage
307 Hospital of PLA
Beijing, Beijing Municipality, China
ORR
clinical response rate (ORR) as determined by investigators based on RECIST 1.1 criteria
Time frame: 1 years
DOR
clinical response time (DOR) as determined by investigators based on RECIST 1.1 criteria
Time frame: 1 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.