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 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 non small cell lung cancer/colorectal cancer/cervical cancer, etc. YL202 is an antibody-drug conjugate (ADC) that targets HER3 protein
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
YL202 will be intravenously infused over 60±10 min
Hunan Provincial Tumor Hospital
Changsha, Hunan, China
RECRUITINGObjective response rate (ORR)
ORR: defined as the proportion of patients who achieved a best overall response of complete response (CR) or partial response (PR)
Time frame: Up to approximately 3 years
Progression-free survival (PFS)
PFS: defined as the time interval from the date of the first dose of study drug to the date of first documentation of PD or death due to any cause, whichever occurs first.
Time frame: Up to approximately 3 years
Depth of response (DpR)
DpR: defined as the proportion of target lesion shrinkage from baseline to maximum tumor size.
Time frame: Up to approximately 3 years
Disease control rate (DCR)
DCR: defined as the proportion of patients who achieved a best overall response of complete response (CR), partial response (PR) or stable disease (SD).
Time frame: Up to approximately 3 years
Duration of response (DoR)
DoR: defined as the time interval from the date of the first documentation of objective response (CR or PR) to the date of the first documentation of progressive disease (PD).
Time frame: Up to approximately 3 years
Time to response (TTR)
TTR: defined as the time interval from the date of the first dose of study drug to the date of the first documentation of objective response (CR or PR).
Time frame: Up to approximately 3 years
Overall survival (OS)
OS: defined as the time interval from the date of the first dose of study drug to the date of death due to any cause.
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Time frame: Up to approximately 3 years
Nature and frequency of adverse events (AEs) with severity
Nature and frequency of AEs with severity is aim to evaluate the safety of YL202.
Time frame: Up to approximately 3 years