A Phase I Clinical Study to Evaluate the Safety and Preliminary Efficacy of BC008-1A Injection in Subjects With Recurrent CNS WHO Grade 4 Glioma.
The purpose of this Phase I clinical study is to evaluate the safety, preliminary efficacy and pharmacokinetic characteristics of BC008-1A injection in subjects with recurrent CNS WHO grade 4 glioma. This is a randomized and open-label study, with two dose groups set up, and 10 to 20 subjects will be enrolled in each group.
• Voluntarily sign the informed consent form;
• Recurrent CNS WHO grade 4 glioma: Subjects with CNS WHO grade 4 glioma confirmed by histopathology, who have experienced disease progression as diagnosed by MRI and evaluated by RANO criteria after standard treatment and have no surgical plan;
• Male or female aged ≥ 18 years old;
• Expected survival time ≥ 12 weeks;
• According to the RANO criteria, there is at least one measurable intracranial tumor lesion;
• KPS ≥ 70;
• Have sufficient hematological function, liver function and renal function, and meet the following laboratory test results before enrollment (withoutusing any cell growth factors, platelet and red blood cell transfusion or other blood transfusion treatments within 1 week before the first dose of study treatment):
‣ Basically normal liver function: Total bilirubin (TBIL) ≤ 1.5 × ULN (patients with known Gilbert disease with serum bilirubin level ≤3 × ULN can be included), alanine aminotransferase (ALT) ≤ 2.5 × ULN, aspartate aminotransferase (AST) ≤ 2.5 × ULN, alkaline phosphatase ≤ 2.5 × ULN;
⁃ Basically normal renal function: Creatinine (Cr) ≤ 1.5 × ULN, or estimated glomerular filtration rate (eGFR) ≥ 30 mL/min;
⁃ Basically normal coagulation function: International normalized ratio (INR) ≤ 1.5 × ULN, prothrombin time (PT) ≤ 1.5 × ULN, activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (for subjects receiving anticoagulant treatment, the investigator judges that INR, PT and APTT are within the safe and effective treatment range and there is no clinical condition of active bleeding or increased bleeding risk);
⁃ Basically normal hematological system: Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L (without granulocyte colony-stimulating factor treatment), platelet (PLT) ≥ 100 × 10\^9/L, hemoglobin (Hb) ≥ 90 g/L, white blood cell count ≥ 2.0 × 10\^9/L, lymphocyte count ≥ 0.5 ×10\^9/L.
• Female subjects of childbearing age or male subjects whose partners are women of childbearing age need to agree to take effective contraceptive measures during the trial period (from signing the ICF to 6 months after the last dose).