This is an open-label, phase 1 dose-escalation study of KN026 in subjects with HER2 positive advanced breast and Gastric Cancer. The standard "3 + 3" design was used for dose escalation. There are 3 proposed dose levels which are 10, 15, and 20 mg/kg, but dosing interval may be adjusted during the study (such as QW, OR Q2W, OR Q3W) based on emerging data from this trial and/or from phase 1 trial of KN026 in other country. Dose escalation will continue until the maximum tolerated dose (MTD) is reached or if MTD is not found, dose escalation will continue until the MAD of 20 mg / kg is reached.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Patient will be intravenously administrated with one dose of KN026 every week or every other week.
Greenville Health System Center Institute
Greenville, South Carolina, United States
The proportion of patients experiencing dose limiting toxicities
Time frame: From screening to up to 28 days
Percentage of participants with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest
Time frame: From screening to up to 196 days
Maximum observed serum concentration (Cmax) of KN026
Time frame: Throughout the duration of the study; up to 84 days
Time of Maximum observed serum concentration (Tmax) of KN026
Time frame: Throughout the duration of the study; up to 84 days
Frequency and titer of anti-KN026 antibody
Time frame: Throughout the duration of the study; up to 2 years
The proportion of patients with an objective response (partial response or complete response) as defined by RECIST 1.1 criteria
Time frame: Throughout the duration of the study; up to 2 years
Progression free survival according to RECIST 1.1 criteria
Time frame: Throughout the duration of the study; up to 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.