This study is a multicenter, open-label, phase II study of YL202 in China to evaluate the efficacy, safety, and PK characteristics of YL202 in the following selected patients with advanced solid tumors.
This study is a multicenter, open-label, phase II study of YL202 in China to evaluate the efficacy, safety, and PK characteristics of YL202 in the advanced NSCLC/BC/HNSCC/colorectal cancer/HER2-positive gastric cancer/cervical cancer/ovarian cancer and etc.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
For each patient, YL202 should be intravenously infused over 60±10 min.
ORR 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: approximately within 36 months
Clinical benefit rate (CBR) assessed according to RECIST v1.1
Time frame: approximately within 36 months
depth of response (DpR) assessed according to RECIST v1.1
Time frame: Approximately within 36 months
disease control rate (DCR) assessed according to RECIST v1.1
Time frame: Approximately within 36 months
duration of response (DOR) assessed according to RECIST v1.1
Time frame: Approximately within 36 months
time to response (TTR) assessed according to RECIST v1.1
Time frame: Approximately within 36 months
Evaluate the overall survival (OS)
Time frame: Approximately within 36 months
Adverse event (AE), described in terms of type, frequency, severity, time, and relationship with study treatment
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Anhui Tumour Hospital
Hefei, Anhui, China
RECRUITINGThe first affiliated hospital of Anhui Medical University
Hefei, Anhui, China
RECRUITINGThe Second Hospital of Anhui Medical University
Hefei, Anhui, China
NOT_YET_RECRUITINGBeijing Cancer hospital
Beijing, Beijing Municipality, China
RECRUITINGBeijing Tsinghua Chang Gung Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGPeking University Third Hospital
Beijing, Beijing Municipality, China
RECRUITINGChinese First Affiliated Hospital of Army Medical University of the People's Liberation Army
Chongqing, Chongqing Municipality, China
NOT_YET_RECRUITINGChongqing University Affiliated Tumor Hospital
Chongqing, Chongqing Municipality, China
RECRUITINGThe first affiliated hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
NOT_YET_RECRUITINGThe Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
NOT_YET_RECRUITING...and 72 more locations
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
Establish a POP PK model for exposure-response relationship analysis
Time frame: approximately within 36 months
Evaluate the relatonship between different levels of HER3 expression and the sum of CR rate, PR rate and SD rate
Time frame: approximately within 36 months