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.
Male or female, age ≥ 18 years and ≤ 75 years at the time of signing the informed consent form (ICF).
Participants with histologically or cytologically confirmed NSCLC.
Locally advanced or metastatic NSCLC with MET Abnormalities that has progressed after standard therapy.
At least one measurable lesion as assessed by the investigator according to RECIST v1.1.
Participants with known active central nervous system (CNS) metastasis, and/or carcinomatous meningitis, brainstem metastasis, metastases to spinal cord, or spinal cord compression.
Participants with other malignant tumors within 3 years prior to the first dose.
Presence of any of the following cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors.
Presence of severe and/or uncontrolled concomitant diseases.
Single group
SKB571 for injection
DrugSKB571 for injection is administered every 3 weeks(Q3W) .
AE
Incidence and severity of adverse events (AEs)
ORR
Objective response rate (ORR) assessed by the investigator as per RECIST v1.1.
DCR
Disease control rate (DCR) (assessed by the investigators as per RECIST v1.1)
DOR
Time from the start of the first assessment of CR or PR in tumor patients to PD or death due to any reason.
PFS
Time from start of treatment to progression of disease (PD) or death, whichever occurs first, in patients with tumors.
OS
Time from start of treatment to death due to any reason.
Click on the lead sponsor to view all of their trials.
