Description:
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.
Title
- Brief Title: Study of CD200 Activation Receptor Ligand (CD200AR-L) and Allogeneic Tumor Lysate Vaccine Immunotherapy for Recurrent Glioblastoma
- Official Title: Study of CD200 Activation Receptor Ligand (CD200AR-L) and Allogeneic Tumor Lysate Vaccine Immunotherapy for Recurrent Glioblastoma
Clinical Trial IDs
- ORG STUDY ID:
CRPC #2017LS096
- NCT ID:
NCT04642937
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Treatment with hP1A8 | | hP1A8 |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
hP1A8 | Experimental | Up to 3 dose levels of hP1A8 will be tested with a Dose Level -1 in the event of toxicity. The MTD will be identified using the standard 3+3 design. Upon determination of the MTD, additional patients will be enrolled as part of an expansion cohort. | |
Eligibility Criteria
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).
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Maximum tolerated dose (MTD) of hP1A8 when administered with imiquimod and GBM6-AD |
Time Frame: | 12 months |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Incidence of serious adverse events (SAEs) |
Time Frame: | 12 months |
Safety Issue: | |
Description: | |
Measure: | Time to progression (TTP) |
Time Frame: | 24 months |
Safety Issue: | |
Description: | |
Measure: | Progression free survival (PFS) |
Time Frame: | 24 months |
Safety Issue: | |
Description: | |
Measure: | Overall survival (OS) |
Time Frame: | 24 months |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | OX2 Therapeutics |
Last Updated
March 2, 2021