This phase II trial is evaluating the safety and effectiveness of using a targeted therapy (TTAC-0001) to treat patients with recurrent glioblastoma which progressed on therapy that included BevacizumabA Multicenter, Open-Label, Phase â…¡ Clinical Trial to Evaluate the Safety and Efficacy of TTAC-0001, a Fully Human Monoclonal Antibody in Patients With Recurrent Glioblastoma Progressed on Bevacizumab Including Therapy

Inclusion

1. Provision of signed and dated informed consent prior to any study specific procedures, sampling or analyses.
2. Aged at least 18 years old
3. Patients must have a histologically proven diagnosis of glioblastoma/gliosarcoma
4. Patients must have previous treatment including bevacizumab
5. Patients must have a radiological diagnosis of recurrent/relapsed or progressive glioblastoma/gliosarcoma after bevacizumab including therapy according to response assessment in neuro-oncology (RANO) criteria
6. At least one confirmed measurable lesion or non measurable lesion as determined by RANO criteria
7. Patients must undergo IDH1 mutational testing on a tumor specimen before entering the study. Immunohistochemistry (IHC) is sufficient for enrollment, although DNA sequencing may also be performed as per local institutional guidelines. Patients are eligible regardless of their tumor status.
8. Karnofsky Performance Status (KPS) ≥ 70

9. A person who satisfies the following criteria in hematologic, renal, and hepatic function tests (1) Hematologic tests - Absolute neutrophil count (ANC) ≥ 1.5 x 109/L - Platelets ≥ 75 x 109/L

   - Hemoglobin ≥ 9.0 g/dL (2) Blood coagulation tests

   - Prothrombin time (PT) ≤ 1.5 x Upper limit of normal (ULN)

   - Activated partial thromboplastin Time (aPTT) ≤ 1.5 x ULN (3) Hepatic function tests

   • Total bilirubin ≤ 1.5 x ULN
   • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 3 x ULN (4) Renal function test
   • Creatinine clearance (CrCl) ≥ 30 mL/minute calculated by Cockcroft-Gault formula
10. Life expectancy of at least 12 weeks
11. Females of child bearing potential must have a negative pregnancy test during screening and must not be breastfeeding or intending to become pregnant during the study.
12. Male patients with female partners of child-bearing potential must be willing to use two forms of acceptable contraception, including one barrier method, during their participation in this study and for 16 weeks following the last dose of the study. Refer to section 10.5.1 Restrictions, permitted methods of contraception and definitions.