Dose-escalation Study to Evaluate the Safety and Tolerability of GX-I7 in Patients With Glioblastoma
NCT ID: NCT03619239
Last Updated: 2020-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
15 participants
INTERVENTIONAL
2018-06-20
2020-09-25
Brief Summary
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* Dose-escalation stage: Approximately 12-24 patients will be enrolled.
Detailed Description
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• 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)
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Cohort 1
Patients will receive treatment with GX-I7 at a pre-determined dose (Level I) on Day1 of each cycle.
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.
Cohort 2
Patients will receive treatment with GX-I7 at a pre-determined dose (Level II) on Day1 of each cycle.
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.
Cohort 3
Patients will receive treatment with GX-I7 at a pre-determined dose (Level III) on Day1 of each cycle.
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.
Cohort 4
Patients will receive treatment with GX-I7 at a pre-determined dose (Level IV) on Day1 of each cycle.
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.
Cohort 5(Dose-expansion)
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)
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
2. Is pregnant or breastfeeding
3. Have clinically significant cardiac disease (New York Heart Association, Class II or greater) including myocardial infarction, unstable arrhythmias, and/or unstable angina in the past 3 months
4. Have clinically significant liver disease, including alcoholic, or other hepatitis, cirrhosis, and inherited liver disease or current alcohol abuse
19 Years
ALL
No
Sponsors
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Genexine, Inc.
INDUSTRY
Responsible Party
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Locations
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The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, Seocho, South Korea
Countries
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Other Identifiers
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GX-I7-CA-004
Identifier Type: -
Identifier Source: org_study_id