Cerebral glioma
Conditions
Interventions
Group1:HF1K16 80 mg (D1, 3, 5, 7, 15, 17, 19, 21)
Bevacizumab 7.5 mg/kg (D4, 18)
administered via intravenous infusion over 90+/-10 minutes.
Group2:HF1K16 120 mg (D1, 3, 5, 7, 15, 17, 19, 21)
administered via intravenous infusion over 90+/-10 minut
Group3:HF1K16 160 mg (D1, 3, 5, 7, 15, 17, 19, 21)
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The patient and/or legal guardian must voluntarily sign the written informed consent form. 2. Age >= 18 years and = 60. 6. Adequate function of major organs and bone marrow meeting the following criteria: a) Bone marrow reserve: absolute neutrophil count >= 1.5×10?/L, platelet count >= 90×10?/L, and hemoglobin >= 9.0 g/dL (no blood transfusion or hematopoietic stimulating factor administration within 14 days); b) Coagulation function: activated partial thromboplastin time (APTT) = 60 mL/min (calculated by the Cockcroft-Gault formula); e) Left ventricular ejection fraction (LVEF) >= 50%; f) QTcF interval on electrocardiogram: <450 ms for males and <470 ms for females. 7. Subjects of childbearing potential (including male subjects) must agree to avoid pregnancy and adopt effective contraceptive measures with their partners throughout the study period and within 6 months after the last study drug administration; female subjects must have a negative serum pregnancy test during the screening period prior to the first dose
Exclusion criteria
Exclusion criteria: 1. Any active autoimmune disease, or a history of autoimmune disease requiring systemic steroid therapy with a daily prednisone dose >10 mg or equivalent corticosteroid within 2 weeks prior to study treatment. 2. Uncontrolled epilepsy, hypertension or psychiatric disorders at screening. 3. Severe infection occurring within 4 weeks before the first dose, including but not limited to complications requiring hospitalization, sepsis or severe pneumonia; active infection requiring systemic anti-infective therapy within 2 weeks before the first dose (excluding antiviral therapy for hepatitis B or hepatitis C). 4. Uncontrolled third-space effusion that cannot be effectively managed by drainage or other interventions. 5. Participation in other investigational new drug clinical trials within 4 weeks prior to enrollment. 6. Receipt of anti-tumor therapies including chemotherapy, targeted therapy, biotherapy, immunotherapy, radical radiotherapy, major surgery, etc., within 2 weeks or 3 half-lives (whichever is shorter) before enrollment. 7. History of other active malignant tumors within 5 years prior to enrollment. Subjects with other malignant tumors cured by local treatment are excluded, such as basal cell carcinoma, cutaneous squamous cell carcinoma, cervical carcinoma in situ, etc. 8. Patients with hyperthyroidism are excluded; subjects with hypothyroidism on stable-dose thyroid hormone replacement therapy with stable thyroid function (TSH =3 cardiovascular and cerebrovascular events; or left ventricular ejection fraction (LVEF) <= 50%. 11. HIV infection, active HBV infection (HBV DNA above the upper limit of normal), and active HCV infection (HCV RNA above the upper limit of normal). 12. Subjects deemed by the investigator to have other severe systemic medical conditions or other conditions unsuitable for participation in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety;tolerability;The Recommended Phase 2 Dose (RP2D); | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in MDSC quantity and phenotype;Progression-Free Survival ;Time To Next Intervention;Overall Survival ;Disease Control Rate; | — |
Countries
China
Contacts
Public ContactJinsong Wu
Huashan Hospital, Fudan University
Outcome results
None listed