Vebreltinib Combined With Temozolomide for Glioblastoma (GBM) After Surgery

Last updated: January 20, 2025
Sponsor: Huashan Hospital
Overall Status: Active - Not Recruiting

Phase

2

Condition

Gliomas

Astrocytoma

Treatment

Vebreltinib + Temozolomide

Temozolomide

Clinical Study ID

NCT06780592
KY2024-754
  • Ages 18-65
  • All Genders

Study Summary

The purpose of this study is to explore the effects of Vebreltinib in primary glioblastoma patients receiving a combination therapy of chemotherapy (temozolomidel) and MET-TKI.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Aged 18-65 years, female or male

  2. Newly diagnosed GBM (WHO grade 4) patients with maximal surgical resection

  3. c-MET overexpression diagnosed by IHC

  4. KPS ≥60

  5. Adequate hematological, renal, and hepatic function. All patients should meet the following criteria:

  6. absolute neutrophil count (ANC) ≥1.5 × 109/L and platelet count≥100 × 109/L

  7. serum creatinine clearance ≥80 mL/min

  8. total bilirubin level ≤ 1.5 × ULN (except patients with Gilbert syndrome)

  9. aspartate aminotransferase (AST) ≤ 3.0 × ULN, alanine aminotransferase (ALT) ≤ 3.0 × ULN, and AST/ALT < 2.5 × ULN

  10. The patient and his/her family members were informed and provided signed andinformed consent

Exclusion

Exclusion Criteria:

  1. Any previous postoperative treatment except for concurrent chemoradiotherapy;

  2. Individuals unable to undergo cranial MRI examination;

  3. Active hemorrhage detected by cranial CT or MRI scan before enrollment;

  4. Uncontrolled hypertension;

  5. Decompensated heart failure, unstable angina pectoris, acute myocardial infarction,or persistent and clinically significant arrhythmias within 3 months beforeenrollment;

  6. Anti-HIV (+), or both anti-HCV and HCV-RNA (+), or HBsAg positive with HBV-DNA >1000IU/ml;

  7. Individuals requiring long-term continuous use of hematopoietic growth factors orplatelet transfusions;

  8. Pregnant or lactating women;

  9. Individuals who have received other clinical trial drugs within 30 days before thefirst dose of the study drug;

  10. Individuals deemed unsuitable for participation in this clinical trial by theinvestigator.

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Vebreltinib + Temozolomide
Phase: 2
Study Start date:
January 13, 2025
Estimated Completion Date:
December 31, 2027