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Dose-escalation Study to Evaluate the Safety and Tolerability of GX-I7 in Patients With Glioblastoma | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

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

NCT03619239•Genexine, Inc.

View on ClinicalTrials.gov

Summary

Patients will be enrolled in two stages: * Dose-escalation stage: Approximately 12-24 patients will be enrolled.

Detailed Description

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)

Eligibility

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

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

Exclusion Criteria

•1. Unable to comply with study and follow-up procedures
•2. Is pregnant or breastfeeding
•3. 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
•4. Have clinically significant liver disease, including alcoholic, or other hepatitis, cirrhosis, and inherited liver disease or current alcohol abuse

Locations (1)

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

Seoul, Seocho, South Korea

Key Dates

Start Date

June 20, 2018

Primary Completion Date

September 25, 2020

Completion Date

September 25, 2020

Last Updated

November 10, 2020

Enrollment

ACTUAL participants

Conditions

Newly Diagnosed Glioblastoma

Interventions

GX-I7

DRUG

New Adjuvant Vaccine in Glioblastoma, a Phase 1/2a Study

NCT06622434

Newly Diagnosed Glioblastoma

View study

RECRUITINGPHASE2

Phase 2a Immune Modulation With Ultrasound for Newly Diagnosed Glioblastoma

NCT05864534

Newly Diagnosed GlioblastomaGlioblastoma, Isocitric Dehydrogenase (IDH)-Wildtype+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 10, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

New Adjuvant Vaccine in Glioblastoma, a Phase 1/2a Study

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