ITI-1001 for Glioblastoma

Overseen By Joseph Mauceri

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Immunomic Therapeutics, Inc.

Must be taking: Chemoradiation, TMZ

Must not be taking: Dexamethasone

Disqualifiers: Pregnancy, HIV, Cardiac arrhythmia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

10 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that patients requiring dexamethasone within 7 days before the first vaccination are excluded, which suggests some medications might need to be stopped. It's best to discuss your specific medications with the trial team.

What is the purpose of this trial?

This trial tests a new vaccine for brain cancer. It targets patients with newly diagnosed glioblastoma. The vaccine aims to help the immune system fight the cancer. The treatment has been shown to be safe and feasible in previous studies.

Eligibility Criteria

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.

Inclusion Criteria

Patient and his/her partner agree to use adequate contraception after providing written informed consent through 3 months after the last investigational product dose

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.

Exclusion Criteria

Syncopal episode within 12 months of screening

I do not have severe symptoms like intense headaches, vomiting, or changes in consciousness due to high brain pressure.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Resection

Participants undergo gross/near gross total surgical resection of tumor

1 week

Vaccination and Chemoradiation

Participants receive 2 priming vaccinations in the 4-6 weeks period between surgery and initiation of SOC chemoradiation, followed by 2 post-chemoradiation priming vaccinations and 5 vaccine boosters with maintenance TMZ

9 months

Follow-up

Participants are monitored for safety, efficacy, and immune response, including assessments like NANO scale and peripheral blood T cell activation

15 months

Treatment Details

Interventions

• ITI-1001

Trial Overview 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.

Participant Groups

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

Who Is Running the Clinical Trial?

Immunomic Therapeutics, Inc.

Lead Sponsor

Trials

9

Recruited

480+