Glioblastoma
Conditions
Interventions
Single-arm experimental group:Vibepolimab: 2.0 mg/kg, intravenous infusion, once every 3 weeks (Q3W), administered on Day 1 (D1) of each cycle. The infusion duration is 60 minutes (min) +/- 15 min, wi
Sponsors
Department of Neurosurgery, Tangdu Hospital, Air Force Medical University, PLA
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Aged >= 18 years old; 2.Patients with histologically confirmed glioblastoma multiforme (GBM) and positive EGFR expression by IHC; 3.Having at least one measurable lesion on MRI assessed per the RANO 2.0 criteria; 4.Disease progression after prior surgery, radiotherapy, concurrent chemoradiotherapy and adjuvant chemotherapy; 5.Karnofsky Performance Status (KPS) score >= 60; 6.Eligible for combined pharmacotherapy: (1)Hematologic function: absolute neutrophil count (ANC) >= 1.5×10^9/L, platelet count >= 90×10^9/L, and hemoglobin >=90 g/L; (2)Hepatic function: total bilirubin = 2+, a 24-hour urine collection is required to confirm 24-hour urinary protein quantification <= 1 g; (4)Satisfactory coagulation function: international normalized ratio (INR) or prothrombin time (PT) <= 1.5 times the ULN. For subjects on anticoagulant therapy, PT within the therapeutic range of prescribed anticoagulants is acceptable; 7.For women of childbearing potential: negative urine or serum pregnancy test within 7 days prior to the first study drug administration (Cycle 1, Day 1). Male subjects must agree to use effective contraception throughout the study and for 8 weeks after the last dose of study drug; 8.Ability to comply with study treatment and follow-up procedures; 9.Written informed consent obtained prior to any study-related procedures.
Exclusion criteria
Exclusion criteria: 1.Subjects with known or suspected allergy to the active ingredients, excipients of the study drugs, or contrast agents for imaging examinations; those unable to undergo MRI examination. 2.Human immunodeficiency virus antibody (HIVAb) positive; active tuberculosis; active hepatitis B virus infection (history of hepatitis B with positive HBsAg; positive HBcAb and HBV-DNA copy number above the institutional lower limit of detection); or active hepatitis C virus infection (HCV-RNA above the institutional lower limit of detection). 3.Adverse reactions from previous antitumor therapies that have not recovered to Grade = Grade 3 as defined by NCI-CTCAE v5.0, including resting dyspnea, requirement for continuous oxygen therapy, or a history of interstitial lung disease (ILD). 7.Patients with a prior history of solid organ transplantation. 8.History of severe cardiovascular and cerebrovascular diseases, including but not limited to: severe cardiac rhythm or conduction abnormalities requiring clinical intervention, such as ventricular arrhythmia and third-degree atrioventricular block; prolonged QT interval at rest (QTc > 450 msec in males or QTc > 470 msec in females); acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other Grade >= 3 cardiovascular and cerebrovascular events within 6 months prior to the first study drug administration; heart failure with New York Heart Association (NYHA) functional classification >= Class II. 9.Thromboembolic events such as deep vein thrombosis, arterial thrombosis, and pulmonary embolism within 6 months prior to screening. 10.Receipt of surgery, chemotherapy, targeted therapy, immunotherapy, radioiodine therapy, or radiotherapy within 4 weeks before enrollment, or planned radiotherapy during the study period. 11.Participation in other clinical trials with unapproved investigational drugs or receipt of other investigational treatments within 4 weeks prior to enrollment. 12.History of central nervous system hemorrhage or infarction unrelated to antitumor drugs within 6 months before enrollment, such as stroke or intracerebral and intraocular hemorrhage (including embolic stroke). 13.Lactating females, or women of childbearing potential who refuse to use effective contraception. 14.Diagnosis of another malignant tumor within the past 5 years or current active malignancy, except for cured carcinoma in situ
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Objective Response Rate;6 mouth Progression-Free Survival;6 mouth Overall Survival; | — |
Countries
China
Contacts
Public ContactLiang Wang
Tangdu Hospital, Air Force Medical University, PLA
Outcome results
None listed