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

NCT ID: NCT03733587

Last Updated: 2020-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-17
• Study Completion Date: 2020-05-13

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.

Conditions

Solid Tumor

Study Design

• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cyclophosphamide and GX-I7

Cyclophosphamide and determined dose of GX-I7 of each cycle

Group Type: EXPERIMENTAL

GX-I7

Intervention Type: DRUG

GX-I7 25mg/ml/vial

Cyclophosphamide

Intervention Type: DRUG

Cyclophosphamide 500mg/vial

Interventions

GX-I7

GX-I7 25mg/ml/vial

Intervention Type: DRUG

Cyclophosphamide

Cyclophosphamide 500mg/vial

Intervention Type: DRUG

Other Intervention Names

Endoxan

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genexine, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Minkyu Heo

Role: STUDY_DIRECTOR

Genexine_clinical team

Locations

Seoul National University Bundang Hospital

Seongnam-si, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

GX-I7-CA-005

Identifier Type: -

Identifier Source: org_study_id