Study to Evaluate Safety, Tolerability, and Optimal Dose of Candidate GBM Vaccine VBI-1901 in Recurrent GBM Subjects
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 18
Summary
- Conditions
- Glioblastoma Multiforme
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: 3+ 3 Dose Escalation Therapeutic Vaccine: VBI-1901 The vaccine is formulated with GM-CSF and administered intradermally (ID) or AS01B adjuvant and administered intramuscularly (IM) to patients with recurrent GBM.Masking: None (Open Label)Masking Description: None, open-label Allocation (FDAAA)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 70 years
- Gender
- Both males and females
Description
This is a two-part, dose-escalation study to define the safety, tolerability, and optimal dose level of candidate GBM vaccine VBI-1901 with subsequent extension of optimal dose level in recurrent GBM subjects. Subjects in the dose escalation (Part A of trial) as well as extension phase of the trial ...
This is a two-part, dose-escalation study to define the safety, tolerability, and optimal dose level of candidate GBM vaccine VBI-1901 with subsequent extension of optimal dose level in recurrent GBM subjects. Subjects in the dose escalation (Part A of trial) as well as extension phase of the trial (Part B) will continue to receive vaccine every 4 weeks until tumor progression per iRANO criteria.
Tracking Information
- NCT #
- NCT03382977
- Collaborators
- Not Provided
- Investigators
- Study Director: Francisco Diaz-Mitoma, MD Variation Biotechnologies Inc.
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