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

Phase 1CompletedNCT03619239

Genexine, Inc.15 enrolled

Overview

Patients will be enrolled in two stages: * Dose-escalation stage: Approximately 12-24 patients will be enrolled.

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)

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Newly Diagnosed Glioblastoma

Interventions

GX-I7DRUG

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

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

\[Inclusion Criteria\] 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

Locations (1)

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

Seoul, Seocho, South Korea