Solid Tumor
Conditions
Brief summary
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.
Detailed description
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. This is 4 dose levels and increase dose level after confirm DLT of the previous dose.
Interventions
DRUGGX-I7
GX-I7 25mg/ml/vial
DRUGCyclophosphamide
Cyclophosphamide 500mg/vial
Sponsors
Genexine, Inc.
Study design
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of DLT | within cycle 1(28days) | Incidence of nature of DLTs |
| Incidence and characteristics of AE | up to 24 months | Incidence, nature and severity of adverse events graded according to NCI CTCAEv4.03 |
| ORR | up to 6 months | ORR defined as complete response (CR) or partial response (PR) per RECIST v1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of ADAs | up to 24 months | Incidence of anti-drug antibodies (ADAs) during the study |
| concentration of GX-I7 | up to cycle 3 day 1(approximately 8 weeks) | Serum concentration of GX-I7 at specified timepoints for the Area under the concentration time-curve (AUC) |
Countries
South Korea
Outcome results
None listed