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

Genexine

Status and phase

Completed

Phase 1

Conditions

Solid Tumor

Treatments

Drug: Cyclophosphamide

Drug: GX-I7

Study type

Interventional

Funder types

Industry

Identifiers

GX-I7-CA-005

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.