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ACTIVE NOT RECRUITING
NCT05698199
PHASE1

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

Sponsor: Immunomic Therapeutics, Inc.

View on ClinicalTrials.gov

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).

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2023-08-21

Completion Date

2026-03

Last Updated

2024-12-06

Healthy Volunteers

No

Conditions

Interventions

DRUG

ITI-1001

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.

Locations (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, United States