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Dose-escalation Study to Evaluate the Safety and Tolerability of GX-I7 in Patients With Glioblastoma (GBM)

Primary Purpose

Newly Diagnosed Glioblastoma

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
GX-I7
Sponsored by
Genexine, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Newly Diagnosed Glioblastoma focused on measuring Phase 1b

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

[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 Exclusion Criteria

  1. Unable to comply with study and follow-up procedures
  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

Sites / Locations

  • The Catholic University of Korea Seoul St. Mary's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Cohort 4

Cohort 5(Dose-expansion)

Arm Description

Patients will receive treatment with GX-I7 at a pre-determined dose (Level I) on Day1 of each cycle.

Patients will receive treatment with GX-I7 at a pre-determined dose (Level II) on Day1 of each cycle.

Patients will receive treatment with GX-I7 at a pre-determined dose (Level III) on Day1 of each cycle.

Patients will receive treatment with GX-I7 at a pre-determined dose (Level IV) on Day1 of each cycle.

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)

Outcomes

Primary Outcome Measures

DLT(Dose-Limiting Toxicity) Assessment
Incidence and nature of DLT(Dose-Limiting Toxicity)s
Incidence, nature and severity of Adverse events
Incidence, nature and severity of adverse events graded according to NCI CTCAE v4.0

Secondary Outcome Measures

PD(pharmacodynamic) profile [ALC result]
Changes of ALC(Absolute lymphocyte count) from the baseline
Anti-tumor Activity [OS]
Objective response(OS) defined as the time from the date of diagnosis to the death from any cause
Anti-tumor Activity [PFS]
Progression-free survival (PFS) defined according to iRANO(Immunotherapy Response Assessment for Neuro-Oncology)
Immunogenicity[ ADA and neutralizing antibody]
Incidence of anti-GX-I7 antibody (ADA) and neutralizing antibody during the study
Exploratory Biomarker [serum Interleukin-7]
Changes in serum Interleukin-7

Full Information

First Posted
June 26, 2018
Last Updated
November 8, 2020
Sponsor
Genexine, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03619239
Brief Title
Dose-escalation Study to Evaluate the Safety and Tolerability of GX-I7 in Patients With Glioblastoma
Acronym
GBM
Official Title
A Phase 1b, Dose-escalation Study to Evaluate the Safety, Tolerability, and the Lymphocyte Increasing Effects of GX-I7 Intramuscular Administration in Patients With Glioblastoma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
June 20, 2018 (Actual)
Primary Completion Date
September 25, 2020 (Actual)
Study Completion Date
September 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genexine, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Newly Diagnosed Glioblastoma
Keywords
Phase 1b

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
Patients will receive treatment with GX-I7 at a pre-determined dose (Level I) on Day1 of each cycle.
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
Patients will receive treatment with GX-I7 at a pre-determined dose (Level II) on Day1 of each cycle.
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
Patients will receive treatment with GX-I7 at a pre-determined dose (Level III) on Day1 of each cycle.
Arm Title
Cohort 4
Arm Type
Experimental
Arm Description
Patients will receive treatment with GX-I7 at a pre-determined dose (Level IV) on Day1 of each cycle.
Arm Title
Cohort 5(Dose-expansion)
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
GX-I7
Intervention Description
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.
Primary Outcome Measure Information:
Title
DLT(Dose-Limiting Toxicity) Assessment
Description
Incidence and nature of DLT(Dose-Limiting Toxicity)s
Time Frame
Through study completion, an average of 2 years
Title
Incidence, nature and severity of Adverse events
Description
Incidence, nature and severity of adverse events graded according to NCI CTCAE v4.0
Time Frame
Through study completion, an average of 2 years
Secondary Outcome Measure Information:
Title
PD(pharmacodynamic) profile [ALC result]
Description
Changes of ALC(Absolute lymphocyte count) from the baseline
Time Frame
Through study completion, an average of 2 years
Title
Anti-tumor Activity [OS]
Description
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
Title
Anti-tumor Activity [PFS]
Description
Progression-free survival (PFS) defined according to iRANO(Immunotherapy Response Assessment for Neuro-Oncology)
Time Frame
Through study completion, an average of 2 years
Title
Immunogenicity[ ADA and neutralizing antibody]
Description
Incidence of anti-GX-I7 antibody (ADA) and neutralizing antibody during the study
Time Frame
Through study completion, an average of 2 years
Title
Exploratory Biomarker [serum Interleukin-7]
Description
Changes in serum Interleukin-7
Time Frame
Through study completion, an average of 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
[Inclusion Criteria] Ability to understand and willingness to sign a written informed consent document (ICF). Age ≥ 19 years Able to comply with the study protocol, in the investigator's judgment Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. [Exclusion Criteria] General Exclusion Criteria Unable to comply with study and follow-up procedures Is pregnant or breastfeeding 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 Have clinically significant liver disease, including alcoholic, or other hepatitis, cirrhosis, and inherited liver disease or current alcohol abuse
Facility Information:
Facility Name
The Catholic University of Korea Seoul St. Mary's Hospital
City
Seoul
State/Province
Seocho
ZIP/Postal Code
06591
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Dose-escalation Study to Evaluate the Safety and Tolerability of GX-I7 in Patients With Glioblastoma

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