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

• Status: Completed
• Trial end date: 2020-05-13
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genexine, Inc.
• Treatments: Cyclophosphamide

Criteria

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.