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

• Status: Completed
• Trial end date: 2020-09-25
• Target enrollment: 0
• Participant gender: All

Summary

Patients will be enrolled in two stages:

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genexine, Inc.

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