Glioblastoma, AdultPhase 2NCT03618667
GC1118 in Recurrent Glioblastoma Patients With High EGFR Amplification
A Phase 2 study testing GC1118 in people with Glioblastoma, Adult and EGFR Amplification, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
This study is a phase 2 trial of GC1118, an EGFR monoclonal antibody, for recurrent glioblastoma patients who were treated with standard concurrent chemoradiation. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Glioblastoma, Adult, EGFR Amplification
- What is being tested?
- GC1118
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Jan 2018to 28 Apr 2022
- 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
- written informed consent
- 19 years or older
- patients who experience recurrence following the standard therapy (CCRT, adjuvant temozolomide)
- high EGFR amplification
- available archive tumor sample(s)
- Karnofsky performance status (KPS) > 70
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- life expectancy > 3 months
- adequate end-organ function
- patients who recovered from previous therapy (NCI CTCAE v4.03 Gr 1)
Who cannot join
- patients who had EGFR target agent(s) before screening
- patients who have clinically significant cardiopulmonary dysfunction (cardiovascular disease (> 2grade, NYHA), myocardial infarction within previous 3 months, unstable angina, unstable arrythmia, clinically significant interstitial lung disease)
- patients who had major surgery, open biopsy, or clinically significant trauma within previous 4 weeks
- patients who had investigation drug(s) within previous 4 weeks
- patients who had other malignancy(ies) within previous 3 years (except malignancies with low tendency to metastases or mortality for example, treated cervical intraepithelial neoplasia, skin cancer except melanoma, localized prostate cancer)
- patients who had severe infection within previous 4 weeks
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- HIV infection
- patients who had anti-cancer therapy (surgery, chemo-radiation, chemotherapy, radiation therapy) within previous 4 weeks
- clinically significant liver disease (active hepatitis B viral (HBV) or hepatitis C viral (HCV) infection, alcoholic liver disease etc)
- pregnancy or breast-feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Clinical Study of GC1118 in Recurrent Glioblastoma Patients With High Epidermal Growth Factor Receptor (EGFR) Amplification
This study is a phase 2 trial of GC1118, an EGFR monoclonal antibody, for recurrent glioblastoma patients who were treated with standard concurrent chemoradiation.
Read the detailed description
This study is a phase 2 trial of GC1118, an EGFR monoclonal antibody, for recurrent glioblastoma patients who were treated with standard concurrent chemoradiation.
GC1118 (4mg/kg) will be administered by IV infusion once per week for 4 weeks(28-day cycle) up to 6 cycles.
- Conditions
- Glioblastoma, Adult, EGFR Amplification
- Being tested
- GC1118
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GC1118Drug
GC1118 (4mg/kg) will be administered by IV infusion once per week for 4 weeks(28-day cycles) up to 6 cycles, or till progression or uncontrolled toxicity.
| Study group | Role | What they receive |
|---|---|---|
| single group | Experimental | GC1118 (4mg/kg) will be administered by IV infusion once per week for 4 weeks(28-day cycle) up to 6 cycles, or till progression or uncontrolled toxicity. Receives: Drug: GC1118 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
survival time from screening to progression defined by RANO criteria
Measured: at 6 months
Secondary outcomes (3)
overall survival
survival time from screening to death of any cause
Measured: 6 months, 12 month
overall response rate
best overall response rate defined by RANO criteria
Measured: up to 30months
Exploration of predictive/prognostic biomarkers
according to NGS-based biomarkers(whole exome sequencing and whole transcriptome sequencing)
Measured: up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start22 Jan 2018
- Primary completion8 Sep 2018
- Study completion28 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma, AdultStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Se-Hoon Lee, Samsung Medical Center
- Investigators
- sehoon lee, professor, Study director, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03618667
- Sponsor's protocol ID
- SMC2017-06-111
- Status last verified
- Nov 2022
- First submitted
- 7 Jul 2018
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study of GC1118 in Recurrent Glioblastoma Patients With High Epidermal Growth Factor Receptor (EGFR) Amplification
- ClinicalTrials.gov ID
- NCT03618667
- Acronym / sponsor ID
- SMC2017-06-111
- Conditions
- Glioblastoma, Adult, EGFR Amplification
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 22 Jan 2018 (actual)
- Primary completion
- 8 Sep 2018 (actual)
- Study completion
- 28 Apr 2022 (actual)
- First posted
- 7 Aug 2018 (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.
This study is a phase 2 trial of GC1118, an EGFR monoclonal antibody, for recurrent glioblastoma patients who were treated with standard concurrent chemoradiation.
Detailed description
This study is a phase 2 trial of GC1118, an EGFR monoclonal antibody, for recurrent glioblastoma patients who were treated with standard concurrent chemoradiation.
GC1118 (4mg/kg) will be administered by IV infusion once per week for 4 weeks(28-day cycle) up to 6 cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single group | Experimental | Drug: GC1118GC1118 (4mg/kg) will be administered by IV infusion once per week for 4 weeks(28-day cycle) up to 6 cycles, or till progression or uncontrolled toxicity. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- written informed consent
- 19 years or older
- patients who experience recurrence following the standard therapy (CCRT, adjuvant temozolomide)
- high EGFR amplification
- available archive tumor sample(s)
Key exclusion criteria (10 listed)
- patients who had EGFR target agent(s) before screening
- patients who have clinically significant cardiopulmonary dysfunction (cardiovascular disease (> 2grade, NYHA), myocardial infarction within previous 3 months, unstable angina, unstable arrythmia, clinically significant interstitial lung disease)
- patients who had major surgery, open biopsy, or clinically significant trauma within previous 4 weeks
- patients who had investigation drug(s) within previous 4 weeks
- patients who had other malignancy(ies) within previous 3 years (except malignancies with low tendency to metastases or mortality for example, treated cervical intraepithelial neoplasia, skin cancer except melanoma, localized prostate cancer)
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 |
|---|---|---|
| GC1118GC1118 (4mg/kg) will be administered by IV infusion once per week for 4 weeks(28-day cycles) up to 6 cycles, or till progression or uncontrolled toxicity. | Drug | single group |
Primary outcome
Progression-free survival
Time frame: at 6 months
survival time from screening to progression defined by RANO criteria
3 secondary outcomes
overall survival
Time frame: 6 months, 12 month
overall response rate
Time frame: up to 30months
Exploration of predictive/prognostic biomarkers
Time frame: up to 30 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Individual participant dataSharing planned: Undecided
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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.
sehoon lee, professor study director
Samsung Medical Center
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 GC1118 in people with Glioblastoma, Adult and EGFR Amplification, run by Samsung Medical Center 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 9 inclusion and 10 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: finished, as of the sponsor's last update on 12 May 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?
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?
Progression-free survival (time frame: at 6 months). 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 May 2023.