At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 35 enrolled
Drug / intervention
GX-I7drug
Likely dose
GX-I7 25mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1b, Open Label, Dose-escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GX-I7 in Patients With Locally Advanced or Metastatic Solid Tumors
In Brief
A Phase 1 clinical trial evaluating GX-I7 for Locally Advanced or Metastatic Solid Tumors. Completed, enrolled 35 participants across 3 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSouth Korea
Collaborators--
Timeline
Phase 1CompletedFinished
201820192020202120222023202420252026
Enrollment StartMar 2018
First PostedMar 2018
Primary CompletionMar 2020
TodayJul 2026
First PostedMar 27, 2018
Enrollment StartMar 5, 2018
Primary CompletionMar 16, 2020
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 8.3 years ago
Interventions
GX-I7drug
GX-I7 25mg/ml/vial