This is a phase I/II, open-label study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of BPI-361175 tablets in patients with advanced solid tumors including advanced Non-small cell Lung cancer (NSCLC).This is a three-stage study, consisting of Phase Ia dose escalation, Phase Ib dose expansion and pivotal Phase II Study. The pivotal Phase II study will be designed based on data generated from the Phase I studies.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Subjects will receive BPI-361175 until disease progression
Henan Cancer Hospital
Zhengzhou, Henan, China
RECRUITINGTongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGXiangya Hospital of Central South University
Phase I: The adverse events (AEs)
Safety and tolerability will be assessed by monitoring frequency, duration and severity of adverse events (AEs).
Time frame: Through the Phase I, approximately 24 months
Phase I: Determine the recommended Phase II dose (RP2D)
Number of subjects with dose limiting toxicity
Time frame: Through the Phase I, approximately 24 months
Phase II: 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 II, approximately 24 months
Phase I: Evaluate the pharmacokinetics of BPI-361175
Blood plasma concentration
Time frame: Through the Phase I, approximately 24 months
Phase I: 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
Phase II: Disease control rate (DCR)
The proportion of patients with CR, PR and stable disease (SD) in all patients.
Time frame: Through the Phase II, approximately 24 months
Phase II: Progression free survival (PFS)
The time from the first study dose to disease progression (PD) or death, whichever occurs first.
Time frame: Through the Phase II, approximately 24 months
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Changsha, Hunan, China
Hunan cancer hospital
Changsha, Hunan, China
RECRUITINGJiangsu Cancer Hospital
Nanjing, Jiangsu, China
RECRUITINGJiangsu Province Hospital
Nanjing, Jiangsu, China
RECRUITINGShanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGthe First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGPhase II: Overall survival (OS)
The time from the first study dose to death due to any cause.
Time frame: Through the Phase II, approximately 24 months
Phase II: Duration of response (DOR)
The time from the first CR or PR to the first PD or death due to any cause.
Time frame: Through the Phase II, approximately 24 months
Phase II: The adverse events (AEs)
Safety and tolerability will be assessed by monitoring frequency, duration and severity of adverse events (AEs).
Time frame: Through the Phase II, approximately 24 months
Phase I: Disease control rate (DCR)
The proportion of patients with CR, PR and stable disease (SD) in all patients.
Time frame: Through the Phase I, approximately 24 months
Phase I: Progression free survival (PFS)
The time from the first study dose to disease progression (PD) or death, whichever occurs first.
Time frame: Through the Phase I, approximately 24 months
Phase I: Overall survival (OS)
The time from the first study dose to death due to any cause.
Time frame: Through the Phase I, approximately 24 months