CompletedPhase 1

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

United States10 participantsStarted 2023-08-21

Plain-language 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 ≥ 70.
. 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).

Exclusion criteria

. Participation in another therapeutic clinical trial.
. Implantable electronic device.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of participants with Dose Limiting Toxicities (DLTs).

Timeframe: 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.

Timeframe: Through study completion, up to 2 years post baseline.

Trial details

NCT IDNCT05698199

SponsorImmunomic Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-02-11

View on ClinicalTrials.gov More Glioblastoma trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 ≥ 70.
. 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).

Exclusion criteria

. Participation in another therapeutic clinical trial.
. Implantable electronic device.

What they're measuring

Number of participants with Dose Limiting Toxicities (DLTs).

Timeframe: 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.

Timeframe: Through study completion, up to 2 years post baseline.