RecruitingPhase 2NCT07153887

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

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

30 participants

Start Date

Sep 30, 2025

Study Type

INTERVENTIONAL

Conditions

Clear Cell Sarcoma (CCS)

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.

Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called vebreltinib in people with advanced or metastatic clear cell sarcoma (CCS) — a rare type of soft tissue cancer. Vebreltinib targets a protein called MET and may help control tumor growth. **You may be eligible if...** - You are 12 or older - You have been confirmed to have unresectable locally advanced or metastatic clear cell sarcoma - You have had prior surgery, radiation, or chemotherapy - You have at least one measurable tumor - Your heart, liver, kidney, and blood counts are within acceptable ranges - You are willing to use contraception during and for 12 months after treatment **You may NOT be eligible if...** - You have previously received a MET inhibitor or cabozantinib - Your cancer only involves bones with no soft tissue component - You have received other cancer treatment within the past 4 weeks - You have brain cancer spread - You have serious heart, kidney, liver, or lung conditions - You have had a blood clot or stroke in the past 6 months - You are pregnant or breastfeeding - You have an active serious infection or immunodeficiency Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVebreltinib

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).

OTHERStandard medical treatment

standard treatment like chemotherapy, PD1, Anlotinib……

Locations(1)

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

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NCT07153887

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