Clinical trial · Interventional
Study to Evaluate Safety and Tolerability of GX-I7 in Patients With Locally Advanced or Metastatic Solid Tumors
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
NCT03478995CI-TRIAL-00045029completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced or Metastatic Solid Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GX-I7 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GX-I7
- description
- Determined dose of GX-I7 on Day1 of each cycle
- interventionNames
- Drug: GX-I7
Primary outcomes (3)
- measure
- DLT
- timeFrame
- up to 24 months
- description
- Incidence of nature of DLTs
- measure
- AE
- timeFrame
- up to 24 months
- description
- Incidence, nature and severity of adverse events graded according to NCI CTCAEv4.0
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Signed Informed Consent Form (ICF) * Age ≥ 19 years * Able to comply with the study protocol, in the investigator's judgment * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Life expectancy ≥ 12 weeks * Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to the first study treatment (Cycle 1, Day 1) * Serum pregnancy test for women of childbearing potential (including women who have had a tubal ligation) must be performed and documented as negative within 14 days prior to Cycle 1, Day 1 * For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm * Patients with histologic documentation of locally advanced, recurrent, or metastatic incurable solid tumors that has progressed after at least one available standard therapy; or for whom standard therapy has proven to be ineffective or intolerable, or is considered inappropriate * Patients with measurable disease per RECIST v1.1 Exclusion Criteria: * Inability to comply with study and follow-up procedures * Pregnancy, lactation, or breastfeeding * Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within the previous 3 months, unstable arrhythmias, and/or unstable angina * Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, and inherited liver disease or current alcohol abuse * Poorly controlled Type 2 diabetes mellitus defined as a screening hemoglobin A1C ≥ 8% or a fasting plasma glucose ≥ 160 mg/dL (or 8.8 mmol/L) * Major surgical procedure within 28 days prior to Cycle 1, Day 1, or anticipation of need for a major surgical procedure during the study * Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, and/or radiotherapy, within 3 weeks prior to initiation of study treatment * Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤ 1 except for alopecia, vitiligo, or endocrinopathy managed with replacement therapy * History of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Bell's palsy, Guillain-Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis * Primary CNS malignancy, untreated CNS metastases, or active CNS metastases (progressing or requiring corticosteroids for symptomatic control) * History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
References
Publications (2)
- DERIVEDJang 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. PMID 42012895
- DERIVEDKim 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. PMID 40490502