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

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 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.

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.