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Patients will be enrolled in two stages:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GX-I7 | Experimental | Determined dose of GX-I7 on Day1 of each cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GX-I7 | Drug | GX-I7 25mg/ml/vial |
|
| Measure | Description | Time Frame |
|---|---|---|
| DLT | Incidence of nature of DLTs | up to 24 months |
| AE | Incidence, nature and severity of adverse events graded according to NCI CTCAEv4.0 | up to 24 months |
| ECG test evaluated by QTc | Change QTc from baseline (> 500 msec) | up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) profile | Serum concentration of GX-I7 at specified timepoints for the Area under the concentration time-curve (AUC) | up to cycle 3 day 1(approximately 9 weeks) |
| Anti-tumor activity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joo Hyuk Sohn, MD | Yonsei University Health System, Severance Hospital | Principal Investigator |
| Tae Won Kim, MD | Medical Oncology, Asan Medical Center | Principal Investigator |
| Myoung-Ah Lee, MD | Medical Oncology, Seoul St. Mary's Hospital, of the Catholic University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital | Seoul | 03722 | South Korea | |||
| Asan Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42012895 | Derived | 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. | |
| 40490502 | Derived |
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| ID | Term |
|---|---|
| C000712767 | efineptakin alfa |
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Objective response, defined as a complete response (CR) or partial response (PR) per RECIST v.1.1, as determined by the investigator
| up to 24 months |
| Immunogenicity | Incidence of anti-drug antibodies (ADAs) during the study | up to 24 months |
| Exploratory Biomarker | Changes in immune infiltrates, immune-related gene expression in tumor tissue prior to and during study treatment | up to 24 months |
| Seoul |
| 05505 |
| South Korea |
| Seoul St. Mary's Hospital, of the Catholic University | Seoul | South Korea |
| 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. |