A Phase II Clinical Study of SKB571 as Monotherapy in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With MET Abnormalities

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • SKB571 for injection

Treatment groups

60 Participants
are divided into 1 treatment group