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Virus Therapy

ITI-1001 for Glioblastoma

Phase 1
Recruiting
Research Sponsored by Immunomic Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Karnofsky performance status ≥ 70
Newly diagnosed patients with histopathological diagnosis of WHO grade IV glioma (GBM)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, up to 2 years post baseline.
Awards & highlights

Study Summary

This trial will test a new drug to treat people with glioblastoma, a brain tumor. It'll check how safe & effective the drug is.

Who is the study for?
Adults over 18 with newly diagnosed glioblastoma who've had most of their tumor surgically removed and are set for standard chemoradiation. They should expect to live at least 3 more months, have good organ function, agree to use contraception, and not be in other clinical trials or have certain health conditions that could interfere with the study.Check my eligibility
What is being tested?
The trial is testing ITI-1001 at a dose of 8 mg to see if it's safe and tolerable for patients with new glioblastoma. It also looks at how the body responds to the drug (immunogenicity) and whether it seems effective against this type of brain cancer.See study design
What are the potential side effects?
Specific side effects aren't listed here, but generally, participants will be monitored for any adverse reactions related to ITI-1001 which can range from mild injection site reactions to more serious immune responses or organ-related issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am able to care for myself but may not be able to do active work.
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I have been newly diagnosed with a high-grade brain tumor.
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My kidney function is within the normal range.
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I am 18 years old or older.
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I had surgery to remove most of my tumor, and the MRI shows a very small amount left.
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My liver is functioning well, with normal bilirubin and enzyme levels.
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My blood tests show I have enough red cells, platelets, and white cells.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, up to 2 years post baseline.
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 2 years post baseline. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 participants with Dose Limiting Toxicities (DLTs).
Other outcome measures
Exploratory endpoints include changes in immune response
Exploratory endpoints include changes in peripheral blood assessment of T cell activation
Exploratory endpoints include evaluation preliminary efficacy; Neurological Assessment in Neuro-oncology (NANO) analysis
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Participants with Newly Diagnosed Glioblastoma (GBM)Experimental Treatment1 Intervention
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

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Who is running the clinical trial?

Immunomic Therapeutics, Inc.Lead Sponsor
8 Previous Clinical Trials
466 Total Patients Enrolled
2 Trials studying Glioblastoma
181 Patients Enrolled for Glioblastoma

Media Library

ITI-1001 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05698199 — Phase 1
Glioblastoma Clinical Trial 2023: ITI-1001 Highlights & Side Effects. Trial Name: NCT05698199 — Phase 1
ITI-1001 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05698199 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How secure is the prognosis for individuals diagnosed with Glioblastoma (GBM)?

"Our team at Power has assessed the safety of Participants with Newly Diagnosed Glioblastoma (GBM) to be a 1, as this is only Phase 1 and there remains limited evidence in regards to its efficacy and security."

Answered by AI

Has recruitment for this experiment commenced yet?

"Unfortunately, based on the information available through clinicaltrials.gov this trial is not currently enrolling new patients; although it was first posted in January 1st 2023 and last updated a little over two weeks later. At present, there are an abundance of other studies that may be actively seeking participants - 439 to be exact."

Answered by AI
~7 spots leftby Jun 2025