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Brief Title: KN026 Combined With KN046 in Subjects With HER2 Positive Solid Tumor
Official Title: A Phase Ib Study to Evaluate Efficacy, Safety and Tolerability of KN026 Combined With KN046 in Subjects With HER2 Positive Solid Tumor
Study ID: NCT04040699
Brief Summary: This is a phase Ib, open-label, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of KN026 combined with KN046 in subjects with advanced HER2 positive solid tumors.
Detailed Description: The study is composed of 2 stages. Stage 1 consists of dose escalation cohorts for determining the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D). Part 2 consists of 4 tumor type expansion cohorts for expanding the information on clinical safety, clinical pharmacokinetics and antitumor activity in HER2 positive patients.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Beijing Cancer Hospital, Beijing, Beijing, China
Name: Lin Shen, MD,PhD
Affiliation: Peking University
Role: PRINCIPAL_INVESTIGATOR