A Two-part, Phase I/IIA Dose-Escalation Study to Define the Safety, Tolerability, and Optimal Dose of Candidate GBM Vaccine VBI-1901 With Subsequent Extension of Optimal Dose in Recurrent GBM Subjects
Phase of Trial: Phase I/II
Latest Information Update: 17 Apr 2018
At a glance
- Drugs VBI 1901 (Primary)
- Indications Glioblastoma
- Focus Adverse reactions; First in man
- Sponsors VBI Vaccines
- 17 Apr 2018 According to a VBI Vaccines media release, following DSMB recommendation, VBI has initiated enrollment in the intermediate-dose arm of the dose-escalation phase of this study. Two additional, pre-specified DSMB reviews will occur after the completion of enrollment in the intermediate-dose study arm and the high-dose study arm, respectively.
- 17 Apr 2018 According to a VBI Vaccines media release, upon review of all safety data from the fully enrolled, low-dose patient cohort of the ongoing Phase 1/2a clinical study of VBI-1901 in recurrent Glioblastoma (GBM), the independent Data and Safety Monitoring Board (DSMB) unanimously recommended the continuation of the study without modification.
- 17 Jan 2018 According to a VBI Vaccines media release, first patient has been dosed in this study.