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Patients will be enrolled in two stages:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Patients will receive treatment with GX-I7 at a pre-determined dose (Level I) on Day1 of each cycle. |
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| Cohort 2 | Experimental | Patients will receive treatment with GX-I7 at a pre-determined dose (Level II) on Day1 of each cycle. |
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| Cohort 3 | Experimental | Patients will receive treatment with GX-I7 at a pre-determined dose (Level III) on Day1 of each cycle. |
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| Cohort 4 | Experimental | Patients will receive treatment with GX-I7 at a pre-determined dose (Level IV) on Day1 of each cycle. |
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| Cohort 5(Dose-expansion) | Experimental | 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| DLT(Dose-Limiting Toxicity) Assessment | Incidence and nature of DLT(Dose-Limiting Toxicity)s | Through study completion, an average of 2 years |
| Incidence, nature and severity of Adverse events | Incidence, nature and severity of adverse events graded according to NCI CTCAE v4.0 | Through study completion, an average of 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| PD(pharmacodynamic) profile [ALC result] | Changes of ALC(Absolute lymphocyte count) from the baseline | Through study completion, an average of 2 years |
| Anti-tumor Activity [OS] | Objective response(OS) defined as the time from the date of diagnosis to the death from any cause |
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[Inclusion Criteria]
[Exclusion Criteria] General Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Catholic University of Korea Seoul St. Mary's Hospital | Seoul | Seocho | 06591 | South Korea |
| 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. |
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| ID | Term |
|---|---|
| C000712767 | efineptakin alfa |
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| Through study completion, an average of 2 years |
| Anti-tumor Activity [PFS] | Progression-free survival (PFS) defined according to iRANO(Immunotherapy Response Assessment for Neuro-Oncology) | Through study completion, an average of 2 years |
| Immunogenicity[ ADA and neutralizing antibody] | Incidence of anti-GX-I7 antibody (ADA) and neutralizing antibody during the study | Through study completion, an average of 2 years |
| Exploratory Biomarker [serum Interleukin-7] | Changes in serum Interleukin-7 | Through study completion, an average of 2 years |