Glioblastoma
Conditions
Brief summary
This is a single-center, open-label, dose-range finding Phase I study of hP1A8, a new adjuvant CD200 activation receptor ligand (CD200AR-L), in combination with imiquimod and the GBM6-AD vaccine to treat recurrent glioblastoma (GBM) in adults.
Interventions
DRUGTreatment with hP1A8
Treatment with hP1A8
Sponsors
OX2 Therapeutics
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged 18 years and older. * Confirmed diagnosis of GBM. * Radiographically or histologically proven progression or recurrence of disease at any time after standard of care therapy (radiation, temozolomide, with or without a tumor treatment field device). * Tumor debulking or biopsies may be performed to clinical trial enrollment if indicated and feasible.
Exclusion criteria
* Bevacizumab or targeted therapy within 45 days of enrollment. * Intercurrent immune system disorder such as hypoimmunity (marrow failure, HIV) or hyperimmunity (autoimmune disease). * Unable to complete a standard upfront course of chemoradiotherapy due to disease progression or intolerance of therapy. * History of Gliadel water, GammaTile or other implanted therapeutic agent. * Concurrent use of tumor treatment field devices (e.g. Optune).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose (MTD) of hP1A8 when administered with imiquimod and GBM6-AD | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of serious adverse events (SAEs) | 12 months |
| Time to progression (TTP) | 24 months |
| Progression free survival (PFS) | 24 months |
| Overall survival (OS) | 24 months |
Countries
United States
Outcome results
None listed