Study to Evaluate the Safety, Tolerability, Immunogenicity and Preliminary Efficacy of ITI-1001 In Patients With Newly Diagnosed Glioblastoma (GBM)
brief 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).
detailed description
This Phase I study will evaluate the safety and immunogenicity of 8 mg ITI-1001 DNA vaccine based on safety, immune activation and preliminary assessment of therapeutic benefit of 2 priming vaccinations given in the 4-6 weeks period between definitive surgical resection and initiation of SOC chemoradiation followed by 2 post-chemoradiation priming vaccinations (#3 and #4) and 5 ITI-1001 vaccine boosters given in parallel with maintenance TMZ as per Schedule of Assessments.
The study duration will be approximately 24 months for individual patients, excluding screening and surgery.
ITI-1001 vaccinations will be given in combination with Td toxoid.
8mg of ITI-1001 DNA vaccine will be administered via IM injection with electroporation up to 9 times using the TDS-IM v2.0 Device according to the device manufacturer's instructions and according to the Schedule of Assessments.
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)