drugset / Trial / NCT03478995
Study to Evaluate Safety and Tolerability of GX-I7 in Patients With Locally Advanced or Metastatic Solid Tumors
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
Publications
- Jang H, Kim JY, Kim S, Kim H, Byun MS, Lee MA, Chang JH, Nam DH, Kim TW, Jeun SS, Sohn JH, Park SH, Shin EC. Long-acting IL-7 induces distinct transcriptomic features in peripheral T cells of patients with solid tumors. JCI Insight. 2026 Apr 21;11(11):e203629. doi: 10.1172/jci.insight.203629. eCollection 2026 Jun 8.
- Kim GM, Kim S, Lee MA, Byun MS, Choi D, Yang SH, Woo J, Sung YC, Shin EC, Park SH, Kim TW, Sohn J. GX-I7, a long-acting IL-7, safely and effectively increased peripheral CD8+/CD4+ T cells and TILs in patients with locally advanced or metastatic solid tumours. Br J Cancer. 2025 Sep;133(4):524-532. doi: 10.1038/s41416-025-03069-3. Epub 2025 Jun 9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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.