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.

Study Overview

• Status: Completed
• Conditions: Solid Tumor
• Intervention / Treatment: Drug: GX-I7; Drug: Cyclophosphamide

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seongnam-si, Korea, Republic of
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cyclophosphamide and GX-I7; Cyclophosphamide and determined dose of GX-I7 of each cycle	Drug: GX-I7; GX-I7 25mg/ml/vial; Drug: Cyclophosphamide; Cyclophosphamide 500mg/vial; Other Names: Endoxan

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Genexine, Inc.
• Investigators: Study Director: Minkyu Heo, Genexine_clinical team

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2018
• Primary Completion (Actual): April 2, 2020
• Study Completion (Actual): May 13, 2020

Study Registration Dates

• First Submitted: November 5, 2018
• First Submitted That Met QC Criteria: November 5, 2018
• First Posted (Actual): November 7, 2018

Study Record Updates

• Last Update Posted (Actual): May 14, 2020
• Last Update Submitted That Met QC Criteria: May 12, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Cyclophosphamide
• Other Study ID Numbers: GX-I7-CA-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No