drugset / Trial / NCT03478995

Study to Evaluate Safety and Tolerability of GX-I7 in Patients With Locally Advanced or Metastatic Solid Tumors

NCT03478995

Phase 1 Completed 35 enrolled Genexine, Inc.
SequentialOpen-labelTreatment

Summary

Patients will be enrolled in two stages: * Dose-escalation stage: Approximately 15-30 patients will be enrolled. * Dose-expansion stage: 6-12 patients will be enrolled. Dose-escalation slots will be filled first, then dose-expansion slots.

Timeline

Start
2018-03-05
Primary completion
2020-03-16
Completion
2020-03-16

Drugs

EvaluationDrugModalityDoseRoute
Subject NT-I7 Protein / enzyme biologic 60 ug/kg Intramuscular
Subject NT-I7 Protein / enzyme biologic 720 ug/kg Intramuscular
Subject NT-I7 Protein / enzyme biologic 1200 ug/kg Intramuscular
Subject NT-I7 Protein / enzyme biologic 1700 ug/kg Intramuscular

Indications

No indication recorded.