drugset / Trial / NCT07599371
A Prospective, Single-arm Clinical Study on the Safety and Efficacy of Ivoximab Combined With Temozolomide in the Treatment of Relapsed/Refractory Glioma
NaSingle-groupOpen-labelTreatment
Summary
This study is a prospective, single-arm clinical trial aimed at evaluating the safety and efficacy of ivoximab combined with temozolomide in the treatment of relapsed/refractory glioma. The study plans to enroll 29 patients with relapsed/refractory glioma. After signing informed consent and meeting the inclusion/exclusion criteria through screening, patients will receive treatment with ivoximab combined with temozolomide. Efficacy evaluation will be conducted every two treatment cycles using the Response Assessment in Neuro-Oncology (RANO 2.0) criteria, and treatment will continue until disease progression or intolerance to the combined regimen.
Timeline
- Start
- 2024-10-10
- Primary completion
- 2027-10-10
- Completion
- 2028-10-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ivoximab | Unknown | 20 mg/kg | Intravenous |
| Subject | Temozolomide | Small molecule | 150 mg/m2 | Oral |