Solid TumorPhase 1NCT03733587
GX-I7 With Cyclophosphamide in Patients With Metastatic or Recurrent Solid Tumors
A Phase 1 study testing GX-I7 and Cyclophosphamide in people with Solid Tumor, run by Genexine, Inc. at 2 sites in South Korea.
Trial summary
This is a Phase 1b study to explore the safety and efficacy of GX-I7 in combination with CPA in patients with metastatic or recurrent solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- GX-I7 and Cyclophosphamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 17 Oct 2018to 13 May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological confirmation of solid tumor, for which no standard therapy exists or is available any longer.
- Aged ≥19 years(Korean age).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy ≥12 weeks.
- Adequate hematological and end organ function defined by the following
- laboratory results obtained within 14 days prior to Cycle 1 Day 1 (C1D1)
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- Female subjects of childbearing potential (including a female who has undergone tubal ligation) requires a negative serum pregnancy test performed within 14 days prior to C1D1.
- Have an evaluable lesion(s) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- Subjects to be enrolled in the Phase 2a stage must be able to provide pre-treatment tissue biopsy or archival tissue and must have a tumor lesion.
- Providing the signed informed consent form (ICF).
Who cannot join
- Unable to adhere to the study procedures and follow-up procedures.
- Pregnant or lactating subjects.
- Have alcoholic or other hepatitis, liver cirrhosis, or genetic liver disease.
- Have uncontrolled type 2 diabetes mellitus.
- Have history of a major surgery within 28 days prior to C1D1 or are anticipated to require a major surgery during the study.
- Have an evidence of severe or uncontrolled systemic disease, uncontrolled hypertension.
- Have received any other investigational or approved anticancer therapy within 3 weeks prior to C1D1.
- With a positive result of human immunodeficiency virus (HIV) infection.
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Seoul National University Bundang Hospital
Seongnam-si
Seoul National University Hospital
Seoul
About this study
Official title: A Phase 1b Study of GX-I7 in Combination With Cyclophosphamide in Patients With Metastatic or Recurrent Solid Tumors
This is a Phase 1b study to explore the safety and efficacy of GX-I7 in combination with CPA in patients with metastatic or recurrent solid tumors.
Read the detailed description
This is a Phase 1b study to explore the safety and efficacy of GX-I7 in combination with CPA in patients with metastatic or recurrent solid tumors.
This is 4 dose levels and increase dose level after confirm DLT of the previous dose.
- Conditions
- Solid Tumor
- Being tested
- GX-I7, Cyclophosphamide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GX-I7Drug
GX-I7 25mg/ml/vial
CyclophosphamideDrug
Also called Endoxan
Cyclophosphamide 500mg/vial
| Study group | Role | What they receive |
|---|---|---|
| Cyclophosphamide and GX-I7 | Experimental | Cyclophosphamide and determined dose of GX-I7 of each cycle Receives: Drug: GX-I7; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of DLT
Incidence of nature of DLTs
Measured: within cycle 1(28days)
Incidence and characteristics of AE
Incidence, nature and severity of adverse events graded according to NCI CTCAEv4.03
Measured: up to 24 months
ORR
ORR defined as complete response (CR) or partial response (PR) per RECIST v1.1
Measured: up to 6 months
Secondary outcomes (2)
Incidence of ADAs
Incidence of anti-drug antibodies (ADAs) during the study
Measured: up to 24 months
concentration of GX-I7
Serum concentration of GX-I7 at specified timepoints for the Area under the concentration time-curve (AUC)
Measured: up to cycle 3 day 1(approximately 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start17 Oct 2018
- Primary completion2 Apr 2020
- Study completion13 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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 1
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genexine, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Minkyu Heo, Study director, Genexine_clinical team
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03733587
- Sponsor's protocol ID
- GX-I7-CA-005
- Status last verified
- May 2020
- First submitted
- 5 Nov 2018
- Last updated
- 14 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 14 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Study of GX-I7 in Combination With Cyclophosphamide in Patients With Metastatic or Recurrent Solid Tumors
- ClinicalTrials.gov ID
- NCT03733587
- Acronym / sponsor ID
- GX-I7-CA-005
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Genexine, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Oct 2018 (actual)
- Primary completion
- 2 Apr 2020 (actual)
- Study completion
- 13 May 2020 (actual)
- First posted
- 7 Nov 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 is a Phase 1b study to explore the safety and efficacy of GX-I7 in combination with CPA in patients with metastatic or recurrent solid tumors.
Detailed description
This is a Phase 1b study to explore the safety and efficacy of GX-I7 in combination with CPA in patients with metastatic or recurrent solid tumors.
This is 4 dose levels and increase dose level after confirm DLT of the previous dose.
Study design
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cyclophosphamide and GX-I7 | Experimental | Drug: GX-I7, Drug: CyclophosphamideCyclophosphamide and determined dose of GX-I7 of each cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histological confirmation of solid tumor, for which no standard therapy exists or is available any longer.
- Aged ≥19 years(Korean age).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy ≥12 weeks.
- Adequate hematological and end organ function defined by the following
Key exclusion criteria (8 listed)
- Unable to adhere to the study procedures and follow-up procedures.
- Pregnant or lactating subjects.
- Have alcoholic or other hepatitis, liver cirrhosis, or genetic liver disease.
- Have uncontrolled type 2 diabetes mellitus.
- Have history of a major surgery within 28 days prior to C1D1 or are anticipated to require a major surgery during the study.
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-I7GX-I7 25mg/ml/vial | Drug | Cyclophosphamide and GX-I7 |
| CyclophosphamideAlso: EndoxanCyclophosphamide 500mg/vial | Drug | Cyclophosphamide and GX-I7 |
Primary outcome
Incidence of DLT
Time frame: within cycle 1(28days)
Incidence of nature of DLTs
Incidence and characteristics of AE
Time frame: up to 24 months
Incidence, nature and severity of adverse events graded according to NCI CTCAEv4.03
ORR
Time frame: up to 6 months
ORR defined as complete response (CR) or partial response (PR) per RECIST v1.1
2 secondary outcomes
Incidence of ADAs
Time frame: up to 24 months
concentration of GX-I7
Time frame: up to cycle 3 day 1(approximately 8 weeks)
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 14 May 2020.
- 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_clinical team
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GX-I7 and Cyclophosphamide in people with Solid Tumor, run by Genexine, Inc. at 2 sites 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 10 inclusion and 8 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 14 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Incidence of DLT (time frame: within cycle 1(28days)). The study lists 3 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 14 May 2020.