The purpose of the Phase Ia/Ib study is to evaluate the tolerability, safety, PK, immunogenicity and preliminary anti-tumor activity of IAH0968 in Chinese subjects. Phase Ia is a dose escalation, and it is planned to recruit about 10-19 subjects with HER2-positive advanced malignancies who have failed standard treatment. Phase Ib is a dose expansion, and it is planned to recruit approximately 18 subjects with HER2-positive advanced malignancies who have failed standard treatment. Phase IIa mainly investigates the effectiveness and safety of IAH0968 in HER2-positive subjects with advanced biliary system tumors.
This is a phase I/IIa study to evaluate the safety, tolerability and preliminary efficacy of IAH0968 in patients with HER2-positive advanced solid tumors who have failed standard treatment.