Study to Evaluate the Safety, Tolerability, Immunogenicity and Preliminary Efficacy of ITI-1001 In Patients With Newly Diagnosed Glioblastoma (GBM)

This Phase I clinical trial will evaluate the safety, tolerability, immunogenicity, and preliminary efficacy of 8 mg ITI-1001 in participants with newly diagnosed glioblastoma (GBM).

Inclusion Criteria: 1. Newly diagnosed patients with histopathological diagnosis of WHO grade IV glioma (GBM). 2. Age ≥ 18 years. 3. Patient must have undergone a gross/near-gross total surgical resection of tumor by analysis of residual enhancing tumor remnant on the immediate post-operative MRI (within 72 hours after surgery) as defined by ≤ 3 cm2 residual enhancing tumor longest perpendicular planes by MRI. 4. Planned standard adjuvant chemoradiation (SOC RT + TMZ for 6 weeks). 5. Karnofsky performance status ≥ 70. 6. Life expectancy ≥ 3 months. 7. All patients must be able to understand and be willing to sign written informed consent and aware of the investigational nature of the study. 8. Patient has adequate renal function (creatinine ≤ 1.5 times the upper limit of normal \[ULN\]) or a glomerular filtration rate (GFR) of ≥ 50 mL/min/1.73 m2). 9. Patient has adequate hepatic function, as evidenced by a total bilirubin ≤1.5 times the ULN, aspartate transaminase (AST), and /or alanine transaminase (ALT) ≤3 times the ULN. 10. Patient has adequate bone marrow function, as evidenced by hemoglobin ≥ 9.0 g/dL in the absence of transfusion within the 72 hours prior to the screening visit, platelet count ≥ 100×109cells/L, and absolute neutrophil count (ANC) ≥ 1.5×109 cells/L. 11. Patient and his/her partner agree to use adequate contraception after providing written informed consent through 3 months after the last investigational product dose, as follows: * For women: Negative pregnancy test during screening and at baseline and compliant with 2 methods of medically approved contraceptive regimens during and for 3 months after the treatment period or documented to be surgically sterile or postmenopausal. * For men: Compliant with 2 methods of medically approved contraceptive regimens during and for 3 months after the treatment period or documented to be surgically sterile. 12. Patient is willing to participate in the study and comply with all study requirements. Exclusion Criteria: 1. Participation in another therapeutic clinical trial. 2. Implantable electronic device. 3. Pregnant or breast feeding. 4. Tumor location or tumor primarily located in spinal cord or brain stem, multi-focal disease, or significant leptomeningeal disease. 5. Evidence of significantly increased intracranial pressure (midline shift \> 5mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness). 6. Known history of AIDS/HIV. Testing is not required. 7. Patient has a history of other malignancy treated with curative intent within the previous 3 years with the exception of adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix. Patients with previous invasive cancers are eligible if the treatment was completed more than 3 years prior to initiating current study treatment, and there is no evidence of recurrent disease. 8. Patient has an important medical illness or abnormal laboratory finding that, in the Investigator's opinion, would increase the risk of participating in this study. 9. History of unstable cardiac arrhythmia or palpitations \[e.g., supraventricular tachycardia, atrial fibrillation, frequent ectopy, or sinus bradycardia (i.e., \