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Virus Therapy
ITI-1001 for Glioblastoma
Phase 1
Waitlist Available
Research Sponsored by Immunomic Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, up to 2 years post baseline.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, up to 2 years post baseline.
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 moreTrial 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have severe symptoms like intense headaches, vomiting, or changes in consciousness due to high brain pressure.My cancer is mainly in my spinal cord, brain stem, has spread widely, or is significantly affecting the lining of my brain.I have had heart rhythm problems before joining the study.I have a known history of AIDS or HIV.I don't have metal implants where the treatment will be given.I am able to care for myself but may not be able to do active work.I have been newly diagnosed with a high-grade brain tumor.My kidney function is within the normal range.I had cancer treated to cure over 3 years ago with no current signs of it returning.I don't have any chronic or active neurological disorders that would affect my participation in the study, except for seizures due to GBM which are under control.I need to take dexamethasone within a week before my first ITI-1001 vaccine dose.I am scheduled for standard chemotherapy and radiation treatment.I am 18 years old or older.I have at least 2 good spots for injections that are free of tattoos, thick skin, or keloids.My blood tests show I have enough red cells, platelets, and white cells.My liver is functioning well, with normal bilirubin and enzyme levels.I had surgery to remove most of my tumor, and the MRI shows a very small amount left.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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