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)
Overview
- Phase
- Phase 1
- Intervention
- ITI-1001
- Conditions
- Glioblastoma
- Sponsor
- Immunomic Therapeutics, Inc.
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Number of participants with Dose Limiting Toxicities (DLTs).
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
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).
Detailed Description
This Phase I study will evaluate the safety and immunogenicity of 8 mg ITI-1001 DNA vaccine based on safety, immune activation and preliminary assessment of therapeutic benefit of 2 priming vaccinations given in the 4-6 weeks period between definitive surgical resection and initiation of SOC chemoradiation followed by 2 post-chemoradiation priming vaccinations (#3 and #4) and 5 ITI-1001 vaccine boosters given in parallel with maintenance TMZ as per Schedule of Assessments. The study duration will be approximately 24 months for individual patients, excluding screening and surgery. ITI-1001 vaccinations will be given in combination with Td toxoid. 8mg of ITI-1001 DNA vaccine will be administered via IM injection with electroporation up to 9 times using the TDS-IM v2.0 Device according to the device manufacturer's instructions and according to the Schedule of Assessments.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Newly diagnosed patients with histopathological diagnosis of WHO grade IV glioma (GBM).
- •Age ≥ 18 years.
- •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.
- •Planned standard adjuvant chemoradiation (SOC RT + TMZ for 6 weeks).
- •Karnofsky performance status ≥
- •Life expectancy ≥ 3 months.
- •All patients must be able to understand and be willing to sign written informed consent and aware of the investigational nature of the study.
- •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).
- •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.
- •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.
Exclusion Criteria
- •Participation in another therapeutic clinical trial.
- •Implantable electronic device.
- •Pregnant or breast feeding.
- •Tumor location or tumor primarily located in spinal cord or brain stem, multi-focal disease, or significant leptomeningeal disease.
- •Evidence of significantly increased intracranial pressure (midline shift \> 5mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness).
- •Known history of AIDS/HIV. Testing is not required.
- •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.
- •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.
- •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.
- •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.
Arms & Interventions
Participants with Newly Diagnosed Glioblastoma (GBM)
Ten participants with histopathological diagnosis of WHO grade IV glioma (Glioblastoma; GBM) and have undergone a gross/near gross total surgical resection of tumor by analysis of residual enhancing tumor remnant on the immediate post-operative MRI
Intervention: ITI-1001
Outcomes
Primary Outcomes
Number of participants with Dose Limiting Toxicities (DLTs).
Time Frame: Through study completion, up to 2 years post baseline.
Number of participants that experience any Dose Limiting Toxicities (DLTs).
Number of occurrences of Adverse events/Serious Adverse Events that will be assessed for severity according to the NCI CTCAE, version 5.0.
Time Frame: Through study completion, up to 2 years post baseline.
Number of occurrences of Adverse events/Serious Adverse Events that will be assessed for severity according to the NCI CTCAE, version 5.0.