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

Study Purpose

Patients will be enrolled in two stages:

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 19 Years and Over
Gender All
More Inclusion & Exclusion Criteria

[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] General 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT03619239
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Genexine, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Completed
Countries Korea, Republic of
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Newly Diagnosed Glioblastoma
Additional Details

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)

Arms & Interventions

Arms

Experimental: Cohort 1

Patients will receive treatment with GX-I7 at a pre-determined dose (Level I) on Day1 of each cycle.

Experimental: Cohort 2

Patients will receive treatment with GX-I7 at a pre-determined dose (Level II) on Day1 of each cycle.

Experimental: Cohort 3

Patients will receive treatment with GX-I7 at a pre-determined dose (Level III) on Day1 of each cycle.

Experimental: Cohort 4

Patients will receive treatment with GX-I7 at a pre-determined dose (Level IV) on Day1 of each cycle.

Experimental: Cohort 5(Dose-expansion)

Optimal fixed dose of GX-I7 from Dose-escalation stage on Day1 of each cycle (Maximum tolerable dose or Maximum efficacious dose or Maximum administered dose level or consecutive lower or upper dose level which does not exceed Maximum tolerable dose based on Safety Monitoring Committee(SMC) decision)

Interventions

Drug: - GX-I7

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Seoul, Seocho, Korea, Republic of

Status

Address

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

Seoul, Seocho, 06591

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