NCT07153887

Vebreltinib for Advanced or Metastatic CCS

An Exploratory Clinical Trial of Vebreltinib for the Treatment of Patients With Locally Advanced or Metastatic Clear Cell Sarcoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Clear Cell Sarcoma (CCS)

Interventions

Type	Name	Description
DRUG	Vebreltinib	Vebreltinib： Oral capsule formulation, specification: 100 mg/capsule. Subjects will start medication after enrollment, 200 mg bid po, until disease progression, intolerable toxicity, or death. If disease progression is observed in the first evaluation (2 months after the first administration), if the investigator deems it possible to continue benefiting from targeted therapy, targeted therapy combined with best supportive care can be continued until the second evaluation (4 months).
OTHER	Standard medical treatment	standard treatment like chemotherapy, PD1, Anlotinib……

Timeline

• Start date: 2025-09-30
• Primary completion: 2026-07-15
• Completion: 2027-07-15
• First posted: 2025-09-04
• Last updated: 2025-09-30

Locations

1 site across 1 country: China