This is a phase 1, multicenter, open-label stydy to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Combination with Serplulimab with or without Platinum-based Chemotherapy in Selected Subjects with Advanced Solid Tumors conducted in China. The study will include 2 parts: a dose escalation part (Part 1) followed by a cohort expansion part (Part 2). Part 1 will estimate the safety, tolerability and MTD/RED(s) of YL201 in combination with serplulimab with or without platinum-based chemotherapy in selected subjects with advanced solid tumors. Part 2 will estimate the efficacy of YL201 in combination with serplulimab with or without platinum-based chemotherapy in selected subjects with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
187
YL201 (High dose, medium dose and low dose; Q3W) in Combination with Serplulimab (4.5mg/kg; Q3W) with or without Platinum(70 mg/m2; Q3W)-based Chemotherapy.
Peking University Cancer Hospital
Beijing, Beijing Municipality, China
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijinig, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
Affiliated Cancer Hospital of Guangxi Medical University
Nanning, Guangxi, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Cancer Hospital Affiliated to Harbin Medical University
Harbin, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
...and 15 more locations
Evaluate the AEs in YL201 combination with serplulimab with or without platinum-based chemotherapy in advanced solid tumors
AE: Adverse Event
Time frame: Approximately within 36 months
To determine the MTD/RED of YL201 in combination with serplulimab with or without platinum-based chemotherapy in advanced solid tumors
maximum tolerated dose (MTD), recommended expansion dose (RED)
Time frame: Approximately within 36 months
To evaluate the efficacy of YL201 in combination with serplulimab with or without platinum-based chemotherapy in advanced solid tumors based on ORR
objective response rate (ORR)
Time frame: Approximately within 36 months
To determine the RP2D of YL201 in combination with serplulimab with or without platinum-based chemotherapy in advanced solid tumors based on ORR
recommended Phase 2 dose (RP2D)
Time frame: Approximately within 36 months
To evaluate the AUC of YL201 combination therapy
area under the curve (AUC)
Time frame: Approximately within 36 months
To evaluate the Cmax of YL201 combination therapy
peak concentration (Cmax)
Time frame: Approximately within 36 months
To evaluate the Ctrough of YL201 combination therapy
trough concentration (Ctrough)
Time frame: Approximately within 36 months
To evaluate the CL of YL201 combination therapy
clearance rate (CL)
Time frame: Approximately within 36 months
To evaluate the Vd of YL201 combination therapy
volume of distribution (Vd)
Time frame: Approximately within 36 months
To evaluate the t1/2 of YL201 combination therapy
half-life time (t1/2)
Time frame: Approximately within 36 months
To evaluate the DpR of YL201 combination therapy
depth of response (DpR); assessed based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Time frame: Approximately within 36 months
To evaluate the DCR of YL201 combination therapy
disease control rate (DCR); assessed based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Time frame: Approximately within 36 months
To evaluate the DoR of YL201 combination therapy
duration of response (DoR); assessed based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Time frame: Approximately within 36 months
To evaluate the TTR of YL201 combination therapy
time to response (TTR); assessed based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Time frame: Approximately within 36 months
To evaluate the PFS of YL201 combination therapy
progression-free survival (PFS); assessed based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Time frame: Approximately within 36 months
To evaluate the OS of YL201 combination therapy
Overall survival (OS)
Time frame: Approximately within 36 months
To evaluate the immunogenicity of YL201 combination therapy
Incidence of anti-YL201 antibodies
Time frame: Approximately within 36 months
To assess the expression level of B7H3 and PD-L1 in Tumor tissue
Time frame: Approximately within 36 months
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