The aim of the study to evaluate the safety and efficacy of SKB571 for injection as monotherapy in patients with locally advanced or metastatic Non-Small Cell Lung Cancer with MET abnormalities. Eligible subjects will receive SKB571 monotherapy, until radiographic disease progression, intolerable toxicity, discontinuation of study treatment required by the subject, or other protocol-specified treatment discontinuation criteria, whichever occurs first.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
SKB571 for injection is administered every 3 weeks(Q3W) .
AE
Incidence and severity of adverse events (AEs)
Time frame: Up to 24 months
ORR
Objective response rate (ORR) assessed by the investigator as per RECIST v1.1.
Time frame: Up to 24 months
DCR
Disease control rate (DCR) (assessed by the investigators as per RECIST v1.1)
Time frame: Up to 24 months
DOR
Time from the start of the first assessment of CR or PR in tumor patients to PD or death due to any reason.
Time frame: Up to 24 months
PFS
Time from start of treatment to progression of disease (PD) or death, whichever occurs first, in patients with tumors.
Time frame: Up to 24 months
OS
Time from start of treatment to death due to any reason.
Time frame: Up to 24 months
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