Trial of KN026 in Patients With HER2-positive Advanced Malignant Breast Cancer and Gastric Cancer
Status:
Unknown status
Trial end date:
2020-08-30
Target enrollment:
Participant gender:
Summary
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 4 proposed dose levels which are 5, 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.