GlioblastomaPhase 1NCT05698199
Study to Evaluate the Safety, Tolerability, Immunogenicity and Preliminary Efficacy of ITI-1001 In Patients With Newly Diagnosed Glioblastoma (GBM)
A Phase 1 study testing ITI-1001 in people with Glioblastoma, run by Immunomic Therapeutics, Inc. at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- ITI-1001
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2023to 1 Jun 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 ≥ 70.
- Life expectancy ≥ 3 months.
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- 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.
- 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.
- Patient is willing to participate in the study and comply with all study requirements.
Who cannot join
- 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.
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- 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.
- Syncopal episode within 12 months of screening.
- 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.
- Patients requiring dexamethasone within 7 days before first priming vaccination of ITI-1001.
- Contraindication to IM injections or blood draws.
- 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).
- Any condition that, in the Investigator's opinion, would render the patient unable to comply with the study procedures and requirements.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
Official title: 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).
Read the 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.
- Conditions
- Glioblastoma
- Being tested
- ITI-1001
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ITI-1001Drug
ITI-1001 DNA vaccine represents a multi-antigen nucleic acid cancer immunotherapy encoding 3 CMV antigens. The vaccine is comprised of 2 DNA plasmids: 1 plasmid encoding IE-1 and pp65 antigens as a fusion protein with LAMP1. Another plasmid encodes gB antigen as a fusion protein with LAMP1.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Newly Diagnosed Glioblastoma (GBM) | Experimental | 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 Receives: Drug: ITI-1001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Dose Limiting Toxicities (DLTs).
Number of participants that experience any Dose Limiting Toxicities (DLTs).
Measured: 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.
Number of occurrences of Adverse events/Serious Adverse Events that will be assessed for severity according to the NCI CTCAE, version 5.0.
Measured: Through study completion, up to 2 years post baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start21 Aug 2023
- Primary completion11 Feb 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Immunomic Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05698199
- Sponsor's protocol ID
- 1001-01-GBM-P1
- Status last verified
- Jun 2026
- First submitted
- 14 Dec 2022
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05698199
- Acronym / sponsor ID
- 1001-01-GBM-P1
- Conditions
- Glioblastoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Immunomic Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Aug 2023 (actual)
- Primary completion
- 11 Feb 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 26 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Newly Diagnosed Glioblastoma (GBM) | Experimental | Drug: ITI-1001Ten 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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 ≥ 70.
Key exclusion criteria (17 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ITI-1001ITI-1001 DNA vaccine represents a multi-antigen nucleic acid cancer immunotherapy encoding 3 CMV antigens. The vaccine is comprised of 2 DNA plasmids: 1 plasmid encoding IE-1 and pp65 antigens as a fusion protein with LAMP1. Another plasmid encodes gB antigen as a fusion protein with LAMP1. | Drug | Participants with Newly Diagnosed Glioblastoma (GBM) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ITI-1001 in people with Glioblastoma, run by Immunomic Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Dose Limiting Toxicities (DLTs). (time frame: Through study completion, up to 2 years post baseline.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.