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

Newly Diagnosed Glioblastoma Clinical Trial

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

Clinical Trial Summary

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

Clinical Trial 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) ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03619239
Study type Interventional
Source Genexine, Inc.
Contact
Status Completed
Phase Phase 1
Start date June 20, 2018
Completion date September 25, 2020
View Details
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