Clinical trial · Interventional
Dose-escalation Study to Evaluate the Safety and Tolerability of GX-I7 in Patients With Glioblastoma
A Phase 1b, Dose-escalation Study to Evaluate the Safety, Tolerability, and the Lymphocyte Increasing Effects of GX-I7 Intramuscular Administration in Patients With Glioblastoma
NCT03619239CI-TRIAL-00048195GBMcompletedPhase 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 12-24 patients will be enrolled.
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 |
|---|---|---|---|
| Newly Diagnosed Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GX-I7 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Cohort 1
- description
- Patients will receive treatment with GX-I7 at a pre-determined dose (Level I) on Day1 of each cycle.
- interventionNames
- Drug: GX-I7
- type
- EXPERIMENTAL
- label
- Cohort 2
- description
- Patients will receive treatment with GX-I7 at a pre-determined dose (Level II) on Day1 of each cycle.
- interventionNames
- Drug: GX-I7
- type
- EXPERIMENTAL
- label
- Cohort 3
- description
- Patients will receive treatment with GX-I7 at a pre-determined dose (Level III) on Day1 of each cycle.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
\[Inclusion Criteria\] 1. Ability to understand and willingness to sign a written informed consent document (ICF). 2. Age ≥ 19 years 3. Able to comply with the study protocol, in the investigator's judgment 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. \[Exclusion Criteria\] General Exclusion Criteria 1. Unable to comply with study and follow-up procedures 2. Is pregnant or breastfeeding 3. Have clinically significant cardiac disease (New York Heart Association, Class II or greater) including myocardial infarction, unstable arrhythmias, and/or unstable angina in the past 3 months 4. Have clinically significant liver disease, including alcoholic, or other hepatitis, cirrhosis, and inherited liver disease or current alcohol abuse
References
Publications (1)
- 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