99
Participants
Start Date
December 31, 2021
Primary Completion Date
December 31, 2025
Study Completion Date
December 31, 2026
Recombinant humanized anti-CD47/PD-1 bifunctional antibody HX009 injection
There will be a total of 4 cohorts, each cohort will explore 1-2 dose levels, i.e. 10 mg/kg and 15 mg/kg, with an expected enrollment of 40-80 cases. The 10 mg/kg dose level will be enrolled first, the After discussion between the sponsor and the DSC, the 15 mg/kg dose level will be enrolled if necessary. Based on the DMC analysis, the no-trend cohort will be enrolled in a maximum of 10 cases (with the possibility of stopping enrollment halfway through).
RECRUITING
Cancer Hospital Chinese Academy of Medical Sciense, Beijing
Lead Sponsor
Hangzhou Hanx Biopharmaceuticals, Ltd.
INDUSTRY