This study is a multicenter, open-label, phase 2 clinical study to evaluate the efficacy, safety and pharmacokinetics of YL202 in patients with locally advanced or metastatic breast cancer with TNBC, HR-positive, HER2-zero-expression or HER2-low-expression
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
For each patient, YL202 should be intravenously infused over 60±10 min.
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGORR assessed according to RECIST v1.1
ORR: defined as the proportion of patients who achieved a best overall response of complete response (CR) or partial response (PR).
Time frame: By the end of trial date, approximately within 36 months
Determination of the recommended dose of YL202 in the pivotal clinical study
Time frame: By the end of trial date, approximately within 36 months
Progression-free survival (PFS) assessed according to RECIST v1.1
Time frame: By the end of trial date, approximately within 36 months
Clinical benefit rate (CBR) assessed based on RECIST v1.1
Time frame: By the end of trial date, approximately within 36 months
Depth of response (DpR) assessed based on RECIST v1.1
Time frame: By the end of trial date, approximately within 36 months
Disease control rate (DCR) assessed based on RECIST v1.1
Time frame: By the end of trial date, approximately within 36 months
Duration of response (DOR) assessed based on RECIST v1.1
Time frame: By the end of trial date, approximately within 36 months
Time to response (TTR) assessed based on RECIST v1.1
Time frame: By the end of trial date, approximately within 36 months
Evaluate the overall survival (OS)
Time frame: By the end of trial date, approximately within 36 months
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Adverse event (AE), described in terms of type, frequency, severity, time, and relationship with study treatment
Time frame: Approximately within 36 months
Characterize the PK parameter AUC
steady-state area under curve (AUC)
Time frame: Approximately within 36 months
Characterize the PK parameter Cmax
peak concentration (Cmax)
Time frame: Approximately within 36 months
Characterize the PK parameter Ctrough
trough concentration (Ctrough)
Time frame: Approximately within 36 months
Characterize the PK parameter CL
clearance (CL)
Time frame: Approximately within 36 months
Characterize the PK parameter Vd
volume of distribution (Vd)
Time frame: Approximately within 36 months
Characterize the PK parameter t1/2
half-life (t1/2)
Time frame: Approximately within 36 months
Incidence of anti-YL202 antibody
Time frame: Approximately within 36 months
Evaluate the corelaton between different levels of HER3 expression and the sum of CR rate, PR rate and SD rate
Time frame: Approximately within 36 months