NCT03619681

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

A Single Arm, Open Lable, Dose Escalation Phase I Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Preliminary Efficacy of KN026 Monotherapy in Patients With HER2-positive Advanced Malignant Breast and Gastric Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer
• Gastric Cancer

Interventions

Type	Name	Description
DRUG	KN026	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.

Timeline

• Start date: 2018-09-17
• Primary completion: 2022-06-30
• Completion: 2022-08-26
• First posted: 2018-08-08
• Last updated: 2024-03-12

Locations

1 site across 1 country: China