A first-in-human study to evaluate the safety, tolerability and maximum tolerated dose (MTD) and establish the recommended phase 2 dose (RP2D) of BPI-371153, a PD-L1 Inhibitor, in patients with advanced solid tumors or relapsed/refractory lymphoma.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
110
Subjects will receive BPI-371153 until disease progression
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Chaoyang, Beijing Municipality, China
RECRUITINGCangzhou Central Hospital
Cangzhou, Hebei, China
COMPLETEDTianjin Cancer Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGThe 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
Determine the recommended Phase II dose (RP2D)
Number of subjects with dose limiting toxicity
Time frame: Through the Phase I, approximately 24 months
Evaluate the pharmacokinetics of BPI-371153
Based on blood plasma concentration
Time frame: Through the Phase I, approximately 24 months
Determination of anti-tumor activity of BPI-371153
Efficacy assessments (tumor evaluation) will be performed per RECIST1.1, mRECIST or Lugano 2014 depending on tumor type.
Time frame: Through the Phase I, approximately 24 months
To explore the levels of expression of PD-L1 associated with BPI-371153 clinical activity
Based on the levels of expression of PD-L1 and anti-tumor activity of BPI-371153
Time frame: Through the Phase I, approximately 24 months
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Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
RECRUITING