This study is an open-label, single arm, dose escalation and dose expansion phase 1 study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of BPI-460372 in solid tumor patients.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
82
Subjects will receive BPI-460372 until disease progression
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGCancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
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
The dose-limiting toxicity(DLT)
The dose-limiting toxicity
Time frame: Through the Phase I, approximately 24 months
Determine the Maximum Tolerated Dose (MTD)
The MTD will be based on DLT.
Time frame: Through the Phase I, approximately 24 months
Evaluate the pharmacokinetics of BPI-460372
Based on blood plasma concentration
Time frame: Time Frame: Through the Phase I, approximately 24 months
Evaluate the effectiveness of BPI-460372
Efficacy assessments (tumor evaluation) will be performed per RECIST1.1 or mRECIST1.1
Time frame: Time Frame: Through the Phase I, approximately 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Affiliated Hospital of Hebei University
Baoding, Hebei, China
RECRUITINGHarbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
NOT_YET_RECRUITINGTongji Hospital Tongji Medical College of HUST
Wuhan, Hubei, China
NOT_YET_RECRUITINGHunan Cancer Hospital
Changsha, Hunan, China
RECRUITINGChina-Japan Union Hospital of Jilin University
Changchun, Jilin, China
NOT_YET_RECRUITINGCentral Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, China
RECRUITINGShandong Cancer Hospital
Jinan, Shandong, China
NOT_YET_RECRUITINGTaizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China
NOT_YET_RECRUITING...and 1 more locations