Trial of KN026 in Patients With HER2-positive Advanced Malignant Breast Cancer and Gastric Cancer

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 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.

Timeline

Start

2018-09-17

Primary completion

2022-06-30

Completion

2022-08-26

Drugs

Indications