NCT03619239

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Genexine, Inc. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Newly Diagnosed Glioblastoma

Interventions

Type	Name	Description
DRUG	GX-I7	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.

Timeline

• Start date: 2018-06-20
• Primary completion: 2020-09-25
• Completion: 2020-09-25
• First posted: 2018-08-07
• Last updated: 2020-11-10

Locations

1 site across 1 country: South Korea