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A Prospective, Single-arm Clinical Study on the Safety and Efficacy of Ivoximab Combined With Temozolomide in the Treatment of Relapsed/Refractory Glioma

NCT07599371 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2026-05-20

No results posted yet for this study

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.

Conditions

  • Relapsed/Refractory Glioma

Interventions

DRUG

Ivoximab 20 mg/kg, ivgtt, Q4W

We have not found any treatment recorded as this combination

DRUG

Temozolomide (TMZ)

Temozolomide 150 mg/m², D1-D5, P.O., Q4W

Sponsors & Collaborators

  • The First Affiliated Hospital of Zhengzhou University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-10
Primary Completion
2027-10-10
Completion
2028-10-10

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07599371 on ClinicalTrials.gov