This open-label Phase 1 study will evaluate the efficacy and safety of BPI-452080 in patients with Solid Tumors
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
87
Subjects will receive BPI-452080 until disease progression
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
West China Hospital of Sichuan University
Chengdu, China
Zhejiang Cancer Hospital
Hangzhou, China
Hunan Cancer Hospital
Hunan, China
adverse events (AEs)
Safety and tolerability will be assessed by monitoring frequency, duration and severity of adverse events
Time frame: Through the Phase I, approximately 24 months
Cmax
Maximum observed concentration
Time frame: Through the Phase I, approximately 24 months
Tmax
Time to reach maximum observed plasma concentration
Time frame: Through the Phase I, approximately 24 months
t1/2
Half-life time
Time frame: Through the Phase I, approximately 24 months
the objective response rate(ORR)
The proportion of patients with complete response (CR) and partial response (PR) in all patients
Time frame: Through the Phase I, approximately 24 months
Progression free survival (PFS)
The time from the date of randomization to disease progression (PD) or death, whichever occurs first
Time frame: Through the Phase I, approximately 24 months
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Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, China