Dose-escalation Study to Evaluate the Safety and Tolerability of GX-I7 in Patients With Glioblastoma

NCT03619239 — Phase 1, Completed, 15 participants, Genexine, Inc.

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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

Registry	NCT03619239, acronym GBM
Status	Completed
Phase	Phase 1
Study type	Interventional; non randomized, sequential, masking: none, treatment
Enrollment	15 (Actual)
Sponsor	Genexine, Inc. (Industry)
Conditions	Newly Diagnosed Glioblastoma
Interventions	GX-I7 (Drug)
Dates	start 2018-06-20, primary completion 2020-09-25, completion 2020-09-25, first posted 2018-08-07, last updated 2020-11-10
Locations	1 site in South Korea

-Summary

Patients will be enrolled in two stages:

* Dose-escalation stage: Approximately 12-24 patients will be enrolled.

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+Detailed description

Detailed Description:

• Dose-escalation stage : designed as classical 3+3 to determine MTD(Maximum tolerable dose), RP2D(Recommended Phase 2 Dose) and DLT(Dose-limiting toxicity)s to evaluate approximately four dose levels of GX-I7

* pre-determined dose(Level I)\~ pre-determined dose(Level IV)

+Arms and interventions

Arm	Type	Interventions	Description
Cohort 1	Experimental	Drug: GX-I7	Patients will receive treatment with GX-I7 at a pre-determined dose (Level I) on Day1 of each cycle.
Cohort 2	Experimental	Drug: GX-I7	Patients will receive treatment with GX-I7 at a pre-determined dose (Level II) on Day1 of each cycle.
Cohort 3	Experimental	Drug: GX-I7	Patients will receive treatment with GX-I7 at a pre-determined dose (Level III) on Day1 of each cycle.
Cohort 4	Experimental	Drug: GX-I7	Patients will receive treatment with GX-I7 at a pre-determined dose (Level IV) on Day1 of each cycle.
Cohort 5(Dose-expansion)	Experimental	Drug: GX-I7	Optimal fixed dose of GX-I7 from Dose-escalation stage on Day1 of each cycle (Maximum tolerable dose or Maximum efficacious dose or Maximum administered dose level or consecutive lower or upper dose level which does not exceed Maximum tolerable dose based on Safety Monitoring Committee(SMC) decision)

GX-I7 (Drug): During Treatment Period, patients will receive the assigned dose of GX-I7 intramuscular injection every 4\~12 weeks per cycle up to 6 cycles in the absence of unacceptable toxicity or clinically compelling evidence of disease progression.

+Outcome measures

Primary outcomes

DLT(Dose-Limiting Toxicity) Assessment [Through study completion, an average of 2 years]: Incidence and nature of DLT(Dose-Limiting Toxicity)s
Incidence, nature and severity of Adverse events [Through study completion, an average of 2 years]: Incidence, nature and severity of adverse events graded according to NCI CTCAE v4.0

Secondary outcomes

PD(pharmacodynamic) profile [ALC result] [Through study completion, an average of 2 years]: Changes of ALC(Absolute lymphocyte count) from the baseline
Anti-tumor Activity [OS] [Through study completion, an average of 2 years]: Objective response(OS) defined as the time from the date of diagnosis to the death from any cause
Anti-tumor Activity [PFS] [Through study completion, an average of 2 years]: Progression-free survival (PFS) defined according to iRANO(Immunotherapy Response Assessment for Neuro-Oncology)
Immunogenicity[ ADA and neutralizing antibody] [Through study completion, an average of 2 years]: Incidence of anti-GX-I7 antibody (ADA) and neutralizing antibody during the study
Exploratory Biomarker [serum Interleukin-7] [Through study completion, an average of 2 years]: Changes in serum Interleukin-7

+Eligibility

Sex: All, ages: 19 Years to any

\[Inclusion Criteria\]

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

+Locations (1)

Facility	City	Country	Status
The Catholic University of Korea Seoul St. Mary's Hospital	Seoul, Seocho	South Korea

+Publications

Results publication: 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. PMID 42012895