Finding studies
Finding studies
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Saves the questions and what to expect into your notes, next to the visit they belong to.
Shuai Wang
CONTACT
Lead
Hangzhou Hanx Biopharmaceuticals, Ltd.
The Part1 safety run-in stage: About 6\~24 patients are expected to be enrolled in the safety run-in stage, 3\~6 cases will be enrolled first in the 7.5mg/kg dose group, and if the 7.5mg/kg dose level is tolerable, then 3\~6 cases will continue to be enrolled up to the 10mg/kg dose group; if the 7.5mg/kg dose group can not be tolerated, it will be decided whether to add a new lower dose level after discussion between the sponsor and the investigators, based on the '3+3' rule, which determines the actual number of cases enrolled, the number of replacement subjects, and the number of dose groups to be explored for each cohort based on observed safety data. Part I Phase IIa stage: Based on data from safety run-in stage , a target ORR of 20% for HX009 in combination with IN10018 in patients with treated advanced biliary cancers was pre-set, and a total of 20-30 subjects were planned to be enrolled at the appropriate recommended dose level, and HX009 in combination with IN10018 for the treatment of patients with advanced biliary malignancies was considered to be a treatment option for HX009 in combination with IN10018 if the best efficacy was observed as a CR or a PR in at least 5 subjects. patients with advanced biliary malignancies, supporting further exploratory studies.
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
