This is a first-in-human (FIH), 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 5 proposed dose levels which are 5, 10, 15, 20 and 30 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. Dose expansion will carried out in 20 mg/kg Q2W and 30 mg/kg Q3W.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
63
Patient will be intravenously administrated with one dose of KN026. dosing interval may be adjusted during the study based on emerging data from this trial and/or from other trial.
Fudan University Shanghai Cancer Hospital
Shanghai, China
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 112 days
Percentage of participants who experience laboratory abnormalities and/or adverse events as defined by CTCAE that are related to treatment
Time frame: From screening to up to 112 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
Adjusted geometric means of area under the serum concentration-time curve from time zero to the time of last quantifiable concentration (AUC(0-T)) for KN026.
Time frame: Throughout the duration of the study; up to 84 days
Serum Half-life (T-HALF) of KN026.
Time frame: Throughout the duration of the study; up to 84 days.
Serum clearance (CL) of KN026.
Time frame: Throughout the duration of the study; up to 84 days
Volume of distribution at steady state (VSS) 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.
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