Objectives:To evaluate the safety and tolerability of BAT8008 for injection in patients with advanced solid tumors, explore the maximum tolerated dose (MTD), and provide the recommended dose for subsequent clinical trials.
In this multi-center, open, dose-increasing, dose-expanding Phase I clinical study, rapid titration and a "3+3" dose-increasing design were used to explore the safety, tolerability and PK characteristics of BAT8008 for injection in patients with advanced solid tumors. During the dose-escalation test, appropriate doses were selected for the extended study according to the previous study data.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
182
Intravenous infusion, once every 2 weeks (Q2W). It is recommended that the infusion time of the first cycle should be ≥ 3 hours. If no infusion reaction occurs, the subsequent circulation can be completed within 1-2 hours.
Affiliated Cancer Hospital of Chongqing University
Chongqing, Chongqing Municipality, China
RECRUITINGZhejiang Cancer Hospital
Hangzhou, Zhejiang, China
RECRUITINGDose limiting toxicity (DLT)
DLT was defined as grade 3 or higher toxicity associated with the investigational product that occurred within 21 days of the subject's initial administration
Time frame: At the end of Cycle 1( first cycle is 21 days, subsequent cycles are 14 days)
Maximum tolerated dose (MTD)
MTD was defined as exploration in a dose group observed ≤1/6 of subjects during the DLT evaluation period to the highest dose level of DLT.
Time frame: At the end of Cycle 1( first cycle is 21 days, subsequent cycles are 14 days)
AUC(0-inf)after cycle 6 administration
The area under the concentration-time curve extrapolated from time 0 to infinity
Time frame: 91 days after first dose of BAT8008
Zhaohe Wang
CONTACT
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