OncoMatch/Clinical Trials/NCT07153887
Vebreltinib for Advanced or Metastatic CCS
Is NCT07153887 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Vebreltinib for clear cell sarcoma (ccs).
Treatment: Vebreltinib — This is a prospective, cohort, multicenter study. Cohort 1 is treatment group. All eligible subjects will receive Vebreltinib (200 mg bid po) after signing the informed consent and meeting the inclusion/exclusion criteria, until disease progression, intolerable toxicity, or death. Subjects will undergo MET abnormality testing after enrollment, including MET amplification or MET protein overexpression. Cohort 2 is external reference group. Subjects diagnosed with CCS and met the inclusion criteria but refused to enter Cohort1 will receive the standard treatment decided by investigators. These subjects will receive follow-up. The efficacy and safety data will be collected. Imaging evaluation will be performed using RECIST v1.1, with CT or MR plain scans every two months (±7 days) until disease recurrence or death. During the study, subjects will receive safety follow-up, and survival follow-up will be conducted every two months after treatment, which can be done by telephone interview for approximately 3 years after treatment ends.
Check if I qualifyExtracted eligibility criteria
Cancer type
Sarcoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: class Ib MET inhibitor
Previous treatment with class Ib MET inhibitors
Cannot have received: MET inhibitor (cabozantinib)
Previous treatment with ... cabozantinib
Lab requirements
Blood counts
Hemoglobin (HB) ≥90g/L; Absolute neutrophil count (ANC) ≥1.5×10⁹/L; Platelets (PLT) ≥100×10⁹/L
Kidney function
Serum creatinine ≤1.5×ULN or creatinine clearance (CCr) ≥60ml/min; Urine protein <2+, and 24h urine protein quantitation ≤1g
Liver function
Total bilirubin ≤1.5× ULN; ALT and AST ≤2.5×ULN, and if with liver metastasis, ALT and AST ≤5×ULN
Cardiac function
Left ventricular ejection fraction (LVEF) ≥ lower limit of normal (60%)
Normal function of major organs, meeting the following criteria within 7 days before treatment:① Hematology examination criteria must be met (without blood transfusion or blood products, and without correction by G-CSF or other hematopoietic stimulating factors within 14 days):a) Hemoglobin (HB) ≥90g/L; b) Absolute neutrophil count (ANC) ≥1.5×10⁹/L; c) Platelets (PLT) ≥100×10⁹/L; ② Biochemical examination must meet the following criteria: a) Total bilirubin (TBIL) ≤1.5× upper limit of normal (ULN); b) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN, and if with liver metastasis，ALT and AST ≤5×ULN; c) Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (CCr) ≥60ml/min; ③ Urine protein <2+, and 24h urine protein quantitation shows protein ≤1g; ④ Coagulation function: INR <2.0 and APTT ≤1.5×ULN ⑤ Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) ≥ lower limit of normal (60%) ⑥ Thyroid function: TSH ≤ upper limit of normal (ULN); if abnormal, T3 and T4 levels should be considered, and subjects can be enrolled if T3 and T4 levels are normal;
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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