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Newly Diagnosed GlioblastomaPhase 1GBMNCT03619239

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

A Phase 1 study testing GX-I7 in people with Newly Diagnosed Glioblastoma, run by Genexine, Inc. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Patients will be enrolled in two stages: Dose-escalation stage: Approximately 12-24 patients will be enrolled. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Newly Diagnosed Glioblastoma
What is being tested?
GX-I7
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteSouth Korea
Study dates
20 Jun 2018to 25 Sep 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

[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 locations and contacts

1 site in 1 country.

South Korea1 site

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

    Seoul, Seocho, 06591

Other trials in South Korea

About this study

Official 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

Patients will be enrolled in two stages:

  • Dose-escalation stage: Approximately 12-24 patients will be enrolled.
Read the 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)
Being tested
GX-I7
Keywords
Phase 1b

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GX-I7Drug

    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.

Study groups in NCT03619239
Study groupRoleWhat they receive
Cohort 1ExperimentalPatients will receive treatment with GX-I7 at a pre-determined dose (Level I) on Day1 of each cycle.
Receives: Drug: GX-I7
Cohort 2ExperimentalPatients will receive treatment with GX-I7 at a pre-determined dose (Level II) on Day1 of each cycle.
Receives: Drug: GX-I7
Cohort 3ExperimentalPatients will receive treatment with GX-I7 at a pre-determined dose (Level III) on Day1 of each cycle.
Receives: Drug: GX-I7
Cohort 4ExperimentalPatients will receive treatment with GX-I7 at a pre-determined dose (Level IV) on Day1 of each cycle.
Receives: Drug: GX-I7
Cohort 5(Dose-expansion)ExperimentalOptimal 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)
Receives: Drug: GX-I7

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. DLT(Dose-Limiting Toxicity) Assessment

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

    Measured: Through study completion, an average of 2 years

  2. Incidence, nature and severity of Adverse events

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

    Measured: Through study completion, an average of 2 years

Secondary outcomes (5)

  1. PD(pharmacodynamic) profile [ALC result]

    Changes of ALC(Absolute lymphocyte count) from the baseline

    Measured: Through study completion, an average of 2 years

  2. Anti-tumor Activity [OS]

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

    Measured: Through study completion, an average of 2 years

  3. Anti-tumor Activity [PFS]

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

    Measured: Through study completion, an average of 2 years

  4. Immunogenicity[ ADA and neutralizing antibody]

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

    Measured: Through study completion, an average of 2 years

  5. Exploratory Biomarker [serum Interleukin-7]

    Changes in serum Interleukin-7

    Measured: Through study completion, an average of 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2018
  2. Study start20 Jun 2018
  3. Primary completion25 Sep 2020
  4. Study completion25 Sep 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03619239
Sponsor's protocol ID
GX-I7-CA-004
Acronym
GBM
Status last verified
Mar 2020
First submitted
26 Jun 2018
Last updated
10 Nov 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Jang H, Kim JY, Kim S, Kim H, Byun MS, Lee MA, Chang JH, Nam DH, Kim TW, Jeun SS, Sohn JH, Park SH, Shin EC. Long-acting IL-7 induces distinct transcriptomic features in peripheral T cells of patients with solid tumors. JCI Insight. 2026 Apr 21;11(11):e203629. doi: 10.1172/jci.insight.203629. eCollection 2026 Jun 8.

    PubMed 42012895

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GX-I7 in people with Newly Diagnosed Glioblastoma, run by Genexine, Inc. at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DLT(Dose-Limiting Toxicity) Assessment (time frame: Through study completion, an average of 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03619239, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2020.

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