GX-I7 With Cyclophosphamide in Patients With Metastatic or Recurrent Solid Tumors

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase 1b Study of GX-I7 in Combination With Cyclophosphamide in Patients With Metastatic or Recurrent Solid Tumors

Conditions
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Solid Tumor

Intervention / Treatment
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* Drug: GX-I7
* Drug: Cyclophosphamide


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cyclophosphamide and GX-I7<br>Cyclophosphamide and determined dose of GX-I7 of each cycle | Drug: GX-I7<br>* GX-I7 25mg/ml/vial<br>Drug: Cyclophosphamide<br>* Cyclophosphamide 500mg/vial<br>* Other names: Endoxan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of DLT | Incidence of nature of DLTs | within cycle 1(28days) | 
| Incidence and characteristics of AE | Incidence, nature and severity of adverse events graded according to NCI CTCAEv4.03 | up to 24 months | 
| ORR | ORR defined as complete response (CR) or partial response (PR) per RECIST v1.1 | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of ADAs | Incidence of anti-drug antibodies (ADAs) during the study | up to 24 months | 
| concentration of GX-I7 | Serum concentration of GX-I7 at specified timepoints for the Area under the concentration time-curve (AUC) | up to cycle 3 day 1(approximately 8 weeks) |