A Phase I, Open Label, First-In-Humans (FIH), Single Dose Level 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., <50
beats per minute on exam)] prior to study entry. Sinus arrhythmia is not excluded.

10. Any chronic or active neurologic disorder that in the opinion of the Investigator
would compromise the patient participation and/or integrity of the study. Patients
with seizures due to recent onset of GBM that are medically controlled are eligible.

11. Syncopal episode within 12 months of screening.

12. Presence of any surgical or traumatic metal implants at the site of administration
(medial deltoid or vastus lateralis muscles or overlying skin) or conditions
incompatible with electroporation per instruction manual of the TriGrid TDS-IM V2.

13. Patients requiring dexamethasone within 7 days before first priming vaccination of
ITI-1001.

14. Contraindication to IM injections or blood draws.

15. Less than 2 acceptable potential injection sites for IM injection and
electroporation considering the left and right medial deltoid, and anterolateral
quadriceps muscles. A site for injection and electroporation is not acceptable if
there is inadequate muscle mass to support at least a 19 mm/0.75 inch injection
depth or a skinfold thickness measurement of ≥50 mm/1.97 inch as assessed using the
provided caliper. Eligible injection sites must also be free from tattoos,
hypertrophic skin patches, keloids or other skin conditions which could interfere
with the administration procedure or subsequent assessment of local reactogenicity.

Note: To ensure adequate muscle mass for administrations, for participants with a
weight ≤65 kg, potentially eligible administration sites are confined to the outer
aspect of the upper thigh (left or right vastus lateralis muscle) (i.e,, the left
and right medial deltoid are not eligible administration sites).

16. Any condition that, in the Investigator's opinion, would render the patient unable
to comply with the study procedures and requirements.