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.
Subjects who are aware of relevant study information prior to the start of the study, and voluntarily sign and date on the informed consent form (ICF).
Subjects aged ≥18 years at the time of giving informed consent
Body mass index (BMI) within the range of 18 to 32 kg/m2.
Subjects with histologically or cytologically confirmed non-Sq NSCLC/CRC/CC or other advanced solid tumor, and had received 1-2 lines of systemic therapy in the advanced/metastatic setting
Prior drug therapy targeting HER3
Previously intolerant to topoisomerase I inhibitors or ADC therapy composed of topoisomerase I inhibitors).
Are participating in another clinical study, unless it is an observational (non-interventional) clinical study or in the follow-up period of an interventional study.
The washout period from the previous anti-tumor therapy is insufficient prior to the first dose of the investigational product.
Parallel
YL202
DrugYL202 will be intravenously infused over 60±10 min
Objective response rate (ORR)
ORR: defined as the proportion of patients who achieved a best overall response of complete response (CR) or partial response (PR)
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.
Depth of response (DpR)
DpR: defined as the proportion of target lesion shrinkage from baseline to maximum tumor size.
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).
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).
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