NCT03847168

KN026 in Patients With HER2 Expressing Breast Cancer and Gastric Cancer

Phase I Study of KN026 in HER2 Expressing Breast Cancer, Astric/Gastroesophageal Junction Cancer and Other Locally Advanced/Metastatic Solid Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Breast Cancer
• Gastric/Gastroesophageal Junction Cancer

Interventions

Type	Name	Description
DRUG	KN026	Patient will be intravenously administrated with one dose of KN026 every week or every other week.

Timeline

• Start date: 2019-06-18
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2019-02-20
• Last updated: 2021-11-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study