Recurrent GlioblastomaPhase 2NCT05191784
GX-I7 in Combination With Bevacizumab in Recurrent Glioblastoma (GBM) Patients
A Phase 2 study testing GX-I7 and Bevacizumab in people with Recurrent Glioblastoma, run by Genexine, Inc. at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of GX-I7 in combination with bevacizumab in subjects with recurrent glioblastoma. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Recurrent Glioblastoma
- What is being tested?
- GX-I7 and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Jan 2022to 31 Dec 2024
- Phase
- Phase 2
- 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
Who may be able to join
- Age ≥ 19 years
- Histologically diagnosed glioblastoma patients who have been confirmed the progression of disease after attempting standard therapy (RT/CCRT and/or adjuvant chemotherapy (TMZ))
- Karnofsky Performance Status; KPS ≥ 60 or ECOG status 0-2
- Life expectancy > 12 weeks
- Adequate hematologic and end organ function
Who cannot join
- Malignancies other than disease under study within 5 years prior to the first dose of study drug
- Subjects who have received bevacizumab or other VEGF inhibitors prior to study participation
- Body Mass Index (BMI) ≥ 30 kg/m2
- Subjects confirmed intracranial hemorrhage with non-contrast CT or MRI
- Clinically significant cardiovascular disease
- History of arterial or venous thromboembolism 6 months prior to study participation
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- Uncontrolled hypertension (blood pressure ≥ 150/90 mmHg with appropriate antihypertensive therapy)
- History of hypertensive crisis or hypertensive encephalopathy
- Subjects receiving therapeutic anticoagulation (except low molecular weight heparin or warfarin)
- Pregnancy or breastfeeding.
- Subjects with active virus infection
- Subjects with autoimmune disease/ syndromes
- Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1 or anticipation that such a live attenuated vaccine will be required during the study
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- Severe infections during the screening period, including but not limited to complications of infection, bacteremia or severe pneumonia
- Prior allogeneic bone marrow transplantation or prior solid organ transplantation
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul St.Mary's Hospital of the Catholic University of Korea
Seoul, 137-701
About this study
Official title: A Phase 2, Open-label, Single-arm Study to Evaluate the Efficacy and Safety of GX-I7 in Combination With Bevacizumab in Recurrent Glioblastoma (GBM) Patients
The purpose of this study is to evaluate the efficacy and safety of GX-I7 in combination with bevacizumab in subjects with recurrent glioblastoma.
Read the detailed description
This is a phase 2 study designed to evaluate the efficacy and safety of GX-I7 in combination with bevacizumab in subjects with recurrent glioblastoma.
A total of 20 patients will be enrolled in the study and administered bevacizumab GX-I7. The study treatment will be continued for up to 6 cycles or until a progression of disease or unacceptable toxicity is confirmed.
- Conditions
- Recurrent Glioblastoma
- Being tested
- GX-I7, Bevacizumab
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GX-I7Drug
Also called rhIL-7-hyFc, Efineptakin alfa
Administered by intramuscular (IM) injection
BevacizumabDrug
Also called Avastin
Administered by intravenous (IV) injection
| Study group | Role | What they receive |
|---|---|---|
| GX-I7 and bevacizumab | Experimental | Bevacizumab at a dose of 10 mg/kg intravenously, and GX-I7 intramuscularly. Receives: Drug: GX-I7; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
Progression free survival (PFS) by iRANO criteria
Measured: From the initiation of study treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
Overall survival (OS)
Overall survival (OS)
Measured: From the initiation of study treatment until the date of death from any cause, assessed up to 24 months.
Secondary outcomes (7)
ORR (Objective response rate)
ORR (Objective response rate) by iRANO criteria
Measured: From the date of complete response or partial response until the date of first documented progression, assessed up to 24 months.
DOR (Duration of response)
DOR (Duration of response) by iRANO criteria
Measured: From the date of complete response or partial response until the date of first documented progression, assessed up to 24 months.
DCR (Disease control rate)
DCR (Disease control rate) by iRANO criteria
Measured: From the date of complete response, partial response, or stable disease until the date of first documented progression, assessed up to 24 months.
Incidence of adverse events (AEs)
The incidence rate of adverse events (AEs) graded according to NCI CTCAE v5.0
Measured: Through study completion, an average of 1 year
Immunogenicity (ADA)
The incidence rate of anti-drug antibodies (ADAs)
Measured: Day 1 and Day 43 of each cycle (8-week interval)
Immunogenicity (neutralizing antibody)
The incidence rate of anti-drug antibodies (neutralizing antibody)
Measured: Day 1 and Day 43 of each cycle (8-week interval)
Absolute counts and ratios of immune cell subtypes
Changes of absolute counts and ratios of immune cell subtypes
Measured: Day 1 and Day 29 of each cycle (8-week interval)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start26 Jan 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genexine, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Minkyu Heo, Study director, Genexine, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05191784
- Sponsor's protocol ID
- GX-I7-CA-010
- Status last verified
- Jun 2023
- First submitted
- 10 Nov 2021
- Last updated
- 12 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-label, Single-arm Study to Evaluate the Efficacy and Safety of GX-I7 in Combination With Bevacizumab in Recurrent Glioblastoma (GBM) Patients
- ClinicalTrials.gov ID
- NCT05191784
- Acronym / sponsor ID
- GX-I7-CA-010
- Conditions
- Recurrent Glioblastoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Genexine, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Jan 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 13 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of GX-I7 in combination with bevacizumab in subjects with recurrent glioblastoma.
Detailed description
This is a phase 2 study designed to evaluate the efficacy and safety of GX-I7 in combination with bevacizumab in subjects with recurrent glioblastoma.
A total of 20 patients will be enrolled in the study and administered bevacizumab GX-I7. The study treatment will be continued for up to 6 cycles or until a progression of disease or unacceptable toxicity is confirmed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GX-I7 and bevacizumab | Experimental | Drug: GX-I7, Drug: BevacizumabBevacizumab at a dose of 10 mg/kg intravenously, and GX-I7 intramuscularly. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 19 years
- Histologically diagnosed glioblastoma patients who have been confirmed the progression of disease after attempting standard therapy (RT/CCRT and/or adjuvant chemotherapy (TMZ))
- Karnofsky Performance Status; KPS ≥ 60 or ECOG status 0-2
- Life expectancy > 12 weeks
- Adequate hematologic and end organ function
Key exclusion criteria (16 listed)
- Malignancies other than disease under study within 5 years prior to the first dose of study drug
- Subjects who have received bevacizumab or other VEGF inhibitors prior to study participation
- Body Mass Index (BMI) ≥ 30 kg/m2
- Subjects confirmed intracranial hemorrhage with non-contrast CT or MRI
- Clinically significant cardiovascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GX-I7Also: rhIL-7-hyFc, Efineptakin alfaAdministered by intramuscular (IM) injection | Drug | GX-I7 and bevacizumab |
| BevacizumabAlso: AvastinAdministered by intravenous (IV) injection | Drug | GX-I7 and bevacizumab |
Primary outcome
Progression free survival (PFS)
Time frame: From the initiation of study treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
Progression free survival (PFS) by iRANO criteria
Overall survival (OS)
Time frame: From the initiation of study treatment until the date of death from any cause, assessed up to 24 months.
Overall survival (OS)
7 secondary outcomes
ORR (Objective response rate)
Time frame: From the date of complete response or partial response until the date of first documented progression, assessed up to 24 months.
DOR (Duration of response)
Time frame: From the date of complete response or partial response until the date of first documented progression, assessed up to 24 months.
DCR (Disease control rate)
Time frame: From the date of complete response, partial response, or stable disease until the date of first documented progression, assessed up to 24 months.
Incidence of adverse events (AEs)
Time frame: Through study completion, an average of 1 year
Immunogenicity (ADA)
Time frame: Day 1 and Day 43 of each cycle (8-week interval)
Immunogenicity (neutralizing antibody)
Time frame: Day 1 and Day 43 of each cycle (8-week interval)
Absolute counts and ratios of immune cell subtypes
Time frame: Day 1 and Day 29 of each cycle (8-week interval)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Minkyu Heo study director
Genexine, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GX-I7 and Bevacizumab in people with Recurrent 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?
The sponsor lists 5 inclusion and 16 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 12 Jun 2023. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Progression free survival (PFS) (time frame: From the initiation of study treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.). 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?
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 12 Jun 2023.