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Completed

NCT Number: NCT03619239

Dose-escalation Study to Evaluate the Safety and Tolerability of GX-I7 in Patients With Glioblastoma

Patients will be enrolled in two stages:

* Dose-escalation stage: Approximately 12-24 patients will be enrolled.

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Key information

Conditions

Newly Diagnosed Glioblastoma

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Catholic University of Korea Seoul St. Mary's Hospital

Seoul, Seocho, 06591, South Korea

About this study

Detailed Description:

  • Dose-escalation stage : designed as classical 3+3 to determine MTD(Maximum tolerable dose), RP2D(Recommended Phase 2 Dose) and DLT(Dose-limiting toxicity)s to evaluate approximately four dose levels of GX-I7
  • pre-determined dose(Level I)~ pre-determined dose(Level IV)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

[Inclusion Criteria]

  • Ability to understand and willingness to sign a written informed consent document (ICF).
  • Age ≥ 19 years
  • Able to comply with the study protocol, in the investigator's judgment
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

[Exclusion Criteria] General Exclusion Criteria

  • Unable to comply with study and follow-up procedures
  • Is pregnant or breastfeeding
  • Have clinically significant cardiac disease (New York Heart Association, Class II or greater) including myocardial infarction, unstable arrhythmias, and/or unstable angina in the past 3 months
  • Have clinically significant liver disease, including alcoholic, or other hepatitis, cirrhosis, and inherited liver disease or current alcohol abuse

Treatment and study plan

GX-I7

Drug

During Treatment Period, patients will receive the assigned dose of GX-I7 intramuscular injection every 4~12 weeks per cycle up to 6 cycles in the absence of unacceptable toxicity or clinically compelling evidence of disease progression.

Primary outcomes

  1. DLT(Dose-Limiting Toxicity) Assessment

    Time frame: Through study completion, an average of 2 years

    Incidence and nature of DLT(Dose-Limiting Toxicity)s

  2. Incidence, nature and severity of Adverse events

    Time frame: Through study completion, an average of 2 years

    Incidence, nature and severity of adverse events graded according to NCI CTCAE v4.0

Secondary outcomes

  1. PD(pharmacodynamic) profile [ALC result]

    Time frame: Through study completion, an average of 2 years

    Changes of ALC(Absolute lymphocyte count) from the baseline

  2. Anti-tumor Activity [OS]

    Time frame: Through study completion, an average of 2 years

    Objective response(OS) defined as the time from the date of diagnosis to the death from any cause

  3. Anti-tumor Activity [PFS]

    Time frame: Through study completion, an average of 2 years

    Progression-free survival (PFS) defined according to iRANO(Immunotherapy Response Assessment for Neuro-Oncology)

  4. Immunogenicity[ ADA and neutralizing antibody]

    Time frame: Through study completion, an average of 2 years

    Incidence of anti-GX-I7 antibody (ADA) and neutralizing antibody during the study

  5. Exploratory Biomarker [serum Interleukin-7]

    Time frame: Through study completion, an average of 2 years

    Changes in serum Interleukin-7

Sponsors and collaborators

Lead sponsor

Genexine, Inc.

Industry

Registry information

Official study title

A Phase 1b, Dose-escalation Study to Evaluate the Safety, Tolerability, and the Lymphocyte Increasing Effects of GX-I7 Intramuscular Administration in Patients With Glioblastoma

Acronym: GBM

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 7, 2018
Registry last updated
Nov 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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