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

Genexine

Status and phase: Completed; Phase 1

Conditions: Newly Diagnosed Glioblastoma

Treatments: Drug: GX-I7

Study type: Interventional

Funder types: Industry

Identifiers

NCT03619239

GX-I7-CA-004

Details and patient eligibility

About

Patients will be enrolled in two stages:

• Dose-escalation stage: Approximately 12-24 patients will be enrolled.

Full 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)

Enrollment: 15 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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15 participants in 5 patient groups

Cohort 1

Experimental group

Description:

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

Treatment:

Drug: GX-I7

Cohort 2

Experimental group

Description:

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

Treatment:

Drug: GX-I7

Cohort 3

Experimental group

Description:

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

Treatment:

Drug: GX-I7

Cohort 4

Experimental group

Description:

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

Treatment:

Drug: GX-I7

Cohort 5(Dose-expansion)

Experimental group

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)

Treatment:

Drug: GX-I7