A Phase 1 interventional study of GX-I7 in Newly Diagnosed Glioblastoma, sponsored by Genexine, Inc.. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2020-11-10.
Sponsored by Genexine, Inc. · Phase 1, Interventional, and Treatment
Patients will be enrolled in two stages:
Detailed Description:
1,919 studies on the registry are indexed under Glioblastoma; 449 are open to participants now.
This study's enrollment of 15 is below the median of 36 across 1,617 interventional studies indexed under Glioblastoma.
Browse Glioblastoma studies →Genexine, Inc. is the lead sponsor of 35 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
[Inclusion Criteria]
[Exclusion Criteria] General Exclusion Criteria
Patients will receive treatment with GX-I7 at a pre-determined dose (Level I) on Day1 of each cycle.
Drug: GX-I7
Patients will receive treatment with GX-I7 at a pre-determined dose (Level II) on Day1 of each cycle.
Drug: GX-I7
Patients will receive treatment with GX-I7 at a pre-determined dose (Level III) on Day1 of each cycle.
Drug: GX-I7
Patients will receive treatment with GX-I7 at a pre-determined dose (Level IV) on Day1 of each cycle.
Drug: GX-I7
Optimal fixed dose of GX-I7 from Dose-escalation stage on Day1 of each cycle (Maximum tolerable dose or Maximum efficacious dose or Maximum administered dose level or consecutive lower or upper dose level which does not exceed Maximum tolerable dose based on Safety Monitoring Committee(SMC) decision)
Drug: GX-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.
DLT(Dose-Limiting Toxicity) Assessment
Incidence and nature of DLT(Dose-Limiting Toxicity)s
Time frame: Through study completion, an average of 2 years
Incidence, nature and severity of Adverse events
Incidence, nature and severity of adverse events graded according to NCI CTCAE v4.0
Time frame: Through study completion, an average of 2 years
PD(pharmacodynamic) profile [ALC result]
Changes of ALC(Absolute lymphocyte count) from the baseline
Time frame: Through study completion, an average of 2 years
Anti-tumor Activity [OS]
Objective response(OS) defined as the time from the date of diagnosis to the death from any cause
Time frame: Through study completion, an average of 2 years
Anti-tumor Activity [PFS]
Progression-free survival (PFS) defined according to iRANO(Immunotherapy Response Assessment for Neuro-Oncology)
Time frame: Through study completion, an average of 2 years
Immunogenicity[ ADA and neutralizing antibody]
Incidence of anti-GX-I7 antibody (ADA) and neutralizing antibody during the study
Time frame: Through study completion, an average of 2 years
Exploratory Biomarker [serum Interleukin-7]
Changes in serum Interleukin-7
Time frame: Through study completion, an average of 2 years
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Genexine, Inc.