Newly Diagnosed Glioblastoma
Conditions
Keywords
Phase 1b
Brief summary
Patients will be enrolled in two stages: * Dose-escalation stage: Approximately 12-24 patients will be enrolled.
Detailed description
Detailed Description: • Dose-escalation stage : designed as classical 3+3 to determine MTD(Maximum tolerable dose), RP2D(Recommended Phase 2 Dose) and DLT(Dose-limiting toxicity)s to evaluate approximately four dose levels of GX-I7 * pre-determined dose(Level I)\ pre-determined dose(Level IV)
Interventions
DRUGGX-I7
During Treatment Period, patients will receive the assigned dose of GX-I7 intramuscular injection every 4\ 12 weeks per cycle up to 6 cycles in the absence of unacceptable toxicity or clinically compelling evidence of disease progression.
Sponsors
Genexine, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\[Inclusion Criteria\] 1. Ability to understand and willingness to sign a written informed consent document (ICF). 2. Age ≥ 19 years 3. Able to comply with the study protocol, in the investigator's judgment 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. \[
Exclusion criteria
\] General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DLT(Dose-Limiting Toxicity) Assessment | Through study completion, an average of 2 years | Incidence and nature of DLT(Dose-Limiting Toxicity)s |
| Incidence, nature and severity of Adverse events | Through study completion, an average of 2 years | Incidence, nature and severity of adverse events graded according to NCI CTCAE v4.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anti-tumor Activity [PFS] | Through study completion, an average of 2 years | Progression-free survival (PFS) defined according to iRANO(Immunotherapy Response Assessment for Neuro-Oncology) |
| PD(pharmacodynamic) profile [ALC result] | Through study completion, an average of 2 years | Changes of ALC(Absolute lymphocyte count) from the baseline |
| Exploratory Biomarker [serum Interleukin-7] | Through study completion, an average of 2 years | Changes in serum Interleukin-7 |
| Immunogenicity[ ADA and neutralizing antibody] | Through study completion, an average of 2 years | Incidence of anti-GX-I7 antibody (ADA) and neutralizing antibody during the study |
| Anti-tumor Activity [OS] | Through study completion, an average of 2 years | Objective response(OS) defined as the time from the date of diagnosis to the death from any cause |
Countries
South Korea
Outcome results
None listed