Individual Patient Compassionate Use of GX-I7
Primary Purpose
Glioblastoma, High Grade Glioma, Recurrent Glioblastoma
Status
No longer available
Phase
Locations
Korea, Republic of
Study Type
Expanded Access
Intervention
GX-I7
Sponsored by
About this trial
This is an expanded access trial for Glioblastoma
Eligibility Criteria
Inclusion Criteria:
-
Exclusion Criteria:
-
Sites / Locations
- Kangnam St. Mary's Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04289155
Brief Title
Individual Patient Compassionate Use of GX-I7
Official Title
Individual Patient Compassionate Use of GX-I7
Study Type
Expanded Access
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genexine, Inc.
4. Oversight
5. Study Description
Brief Summary
Compassionate use of GX-I7 for patients with serious life-threatening illness that have exhausted all available therapies, with no other therapy options.
Detailed Description
This program is being offered on a patient by patient basis and will require company, Institutional Review Board/Independent Ethics Committee and Single Patient IND approval.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma, High Grade Glioma, Recurrent Glioblastoma, Melanoma, Advanced Cancer
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
GX-I7
Intervention Description
patients will receive the assigned dose of GX-I7 intramuscular injection every 4~12 weeks
10. Eligibility
Eligibility Criteria
Inclusion Criteria:
-
Exclusion Criteria:
-
Facility Information:
Facility Name
Kangnam St. Mary's Hospital
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Individual Patient Compassionate Use of GX-I7
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