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

NCT03733587 | Completed Phase 1 DMC

• 1 other identifier: GX-I7-CA-005
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Incidence of ADAs

  up to 24 months

• concentration of GX-I7

  up to cycle 3 day 1(approximately 8 weeks)

Study Arms (1)

Cyclophosphamide and GX-I7

EXPERIMENTAL

Cyclophosphamide and determined dose of GX-I7 of each cycle

Drug: GX-I7; Drug: Cyclophosphamide

Interventions

GX-I7 DRUG

GX-I7 25mg/ml/vial

Cyclophosphamide and GX-I7

Cyclophosphamide DRUG

Cyclophosphamide 500mg/vial

Also known as: Endoxan

Cyclophosphamide and GX-I7

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Genexine, Inc.: lead

Study Sites (2)

Seoul National University Bundang Hospital

Seongnam-si, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

efineptakin alfa; Cyclophosphamide

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Minkyu Heo

  Genexine_clinical team

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2018
• First Posted: November 7, 2018
• Study Start: October 17, 2018
• Primary Completion: April 2, 2020
• Study Completion: May 13, 2020
• Last Updated: May 14, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)