A Phase II Clinical Study of SKB571 as Monotherapy in Patients With Locally Advanced or Metastati… (NCT07308106) | Clinical Trial Compass
RecruitingPhase 2
A Phase II Clinical Study of SKB571 as Monotherapy in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With MET Abnormalities
China60 participantsStarted 2026-04-03
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before the first dose.
✓. Life expectancy ≥ 3 months as assessed by the investigator.
✓. Adequate organ and bone marrow function.
✓. Male and female participants must agree to use highly effective methods of contraception during the study treatment period.
Exclusion criteria
✕. 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.