Clinical trial · Interventional
GX-I7 With Cyclophosphamide in Patients With Metastatic or Recurrent Solid Tumors
A Phase 1b Study of GX-I7 in Combination With Cyclophosphamide in Patients With Metastatic or Recurrent Solid Tumors
NCT03733587CI-TRIAL-00045096completedPhase 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)
This is a Phase 1b study to explore the safety and efficacy of GX-I7 in combination with CPA in patients with metastatic or recurrent solid tumors.
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 |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| GX-I7 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cyclophosphamide and GX-I7
- description
- Cyclophosphamide and determined dose of GX-I7 of each cycle
- interventionNames
- Drug: GX-I7
- Drug: Cyclophosphamide
Primary outcomes (3)
- measure
- Incidence of DLT
- timeFrame
- within cycle 1(28days)
- description
- Incidence of nature of DLTs
- measure
- Incidence and characteristics of AE
- timeFrame
- up to 24 months
- description
- Incidence, nature and severity of adverse events graded according to NCI CTCAEv4.03
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histological confirmation of solid tumor, for which no standard therapy exists or is available any longer. * Aged ≥19 years(Korean age). * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Life expectancy ≥12 weeks. * Adequate hematological and end organ function defined by the following * laboratory results obtained within 14 days prior to Cycle 1 Day 1 (C1D1) * Female subjects of childbearing potential (including a female who has undergone tubal ligation) requires a negative serum pregnancy test performed within 14 days prior to C1D1. * Have an evaluable lesion(s) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 * Subjects to be enrolled in the Phase 2a stage must be able to provide pre-treatment tissue biopsy or archival tissue and must have a tumor lesion. * Providing the signed informed consent form (ICF). Exclusion Criteria: * Unable to adhere to the study procedures and follow-up procedures. * Pregnant or lactating subjects. * Have alcoholic or other hepatitis, liver cirrhosis, or genetic liver disease. * Have uncontrolled type 2 diabetes mellitus. * Have history of a major surgery within 28 days prior to C1D1 or are anticipated to require a major surgery during the study. * Have an evidence of severe or uncontrolled systemic disease, uncontrolled hypertension. * Have received any other investigational or approved anticancer therapy within 3 weeks prior to C1D1. * With a positive result of human immunodeficiency virus (HIV) infection.
References
Publications (0)
Data not yet available
No reference posted for this study.