MelanomaNCT03048253
A Phase I-c Study of Recombinant GM-CSF Herpes Simplex Virus to TreatⅣ M1c
An observational study of Melanoma, run by OrienGene Biotechnology Ltd. at 1 site in China.
Trial summary
Recombinant human GM-CSF herpes simplex virus injection (OrienX010) is a genetically engineered from Chinese patients oral separation of wild type 1 herpes simplex virus (HSV) as the carrier insert GM-CSF gene therapy drug.After gene recombination technology successively removing ICP34.5, ICP47 and insert the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- OrienX010
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 29 Mar 2016to 28 Oct 2019
- Phase
- Observational
- 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
Study population: Melanoma Standard solution phase failure Ⅳ M1c malignant melanoma spread to the liver
Who may be able to join
- By histological and/or cytology diagnosis Ⅳ M1c malignant melanoma patients with liver metastasis, the lack of an effective method for the conventional or the failure of conventional therapy or recurrence
- General physical status score (ECOG) 0-2 points
- Lifetime is expected to more than 4 months
- Always anti-tumor treatment (including/radiation therapy, immune therapy, targeted therapy, endocrine therapy, etc.) to end more than 4 weeks (using the nitroso urea class and mitomycin chemotherapy drug withdrawal over 6 weeks), and always treat the adverse reaction of restored or stability
Who cannot join
- In the group treated with other experimental drugs within 4 weeks before, but in the intervening clinical research (except such as epidemiological studies)
- In group of four weeks before received the treatment of herpes simplex virus, such as acyclovir, ganciclovir, respectively.there is galloway, vidarabine, etc
- In group of four weeks before too much surgery
- Screening stage HSV - 1 antibody IgG and IgM are negative
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing cancer hospital
Beijing, Beijing Municipality, 100010
Chuanliang Cui, PHD, +86-13691489319, cuichuanliang@163.com
Mingfeng Wang, Bachelor, +86-15935989834, wangmingfeng@163.com
About this study
Official title: Recombinant Human GM-CSF Herpes Simplex Virus Injection (OrienX010) Standard Injection in Tumor Treatment Scheme Failed M1c Ⅳ Period Malignant Melanoma Spread to the Liver Open I-c Phase of Clinical Trial
Recombinant human GM-CSF herpes simplex virus injection (OrienX010) is a genetically engineered from Chinese patients oral separation of wild type 1 herpes simplex virus (HSV) as the carrier insert GM-CSF gene therapy drug.After gene recombination technology successively removing ICP34.5, ICP47 and insert the deactivation ICP6 gene, and at the site of the original ICP34.5 insert guided by IE promoter of hCMV human gm-csf gene.The drug after tumor site local injections of dosing, on the one hand, because of the soluble tumor characteristics of herpes simplex virus, reconstructing it after HSV-1 virus carrier at the injection site specific "soluble tumor" kill tumor cells;Viral vector expressed in tumor site, on the other hand, to produce high concentrations of GM-CSF enhance the antitumor immune function, play "beside the destruction effect", have inhibition effect on the distant metastases.
Read the detailed description
Subjects were tested drugs within 8 x 107 pfu/ml tumor injection treatment, the injection quantity according to tumor lesion size, injection amount shall not exceed 10 ml each time, injection frequency for every 2 weeks, 4 times per cycle treatment, treatment 2 cycles. Completed at the end of the second cycle after curative effect evaluation, such as the researchers determine continue to medicine can bring benefit to the subjects, can continue to offer benefits to the subjects' potential drug until disease progression, smaller, not tolerance toxicity or participants to withdraw consent.
- Conditions
- Melanoma
- Being tested
- OrienX010
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrienX010Biological
Beijing biological technology co., LTD. Research and development of the source and force of recombinant human GM-CSF herpes simplex virus injection (OrienX010), is a genetically engineered type 1 herpes simplex virus (HSV - 1) as the carrier insert GM-CSF gene therapy drug.Its carrier is made of isolated from patients with oral Chinese wild single blister virus type I (CL1), after gene recombination technology successively removing ICP34.5, ICP47 and insert the deactivation ICP6 gene, and at the site of the original ICP34.5 insert guided by IE promoter of hCMV human GM-CSF gene.
What is being measured
The primary outcome is the main question the study is designed to answer.
change of tumor size
According to RECIST1.1 method to evaluate the change of tumor size.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study start29 Mar 2016
- Primary completion10 Oct 2017 (estimated)
- Study completion28 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OrienGene Biotechnology Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03048253
- Sponsor's protocol ID
- OrienX010-II-10
- Status last verified
- Feb 2017
- First submitted
- 3 Feb 2017
- Last updated
- 2 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recombinant Human GM-CSF Herpes Simplex Virus Injection (OrienX010) Standard Injection in Tumor Treatment Scheme Failed M1c Ⅳ Period Malignant Melanoma Spread to the Liver Open I-c Phase of Clinical Trial
- ClinicalTrials.gov ID
- NCT03048253
- Acronym / sponsor ID
- OrienX010-II-10
- Conditions
- Melanoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- OrienGene Biotechnology Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Mar 2016 (actual)
- Primary completion
- 10 Oct 2017 (estimated)
- Study completion
- 28 Oct 2019 (estimated)
- First posted
- 9 Feb 2017 (estimated)
- 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.
Recombinant human GM-CSF herpes simplex virus injection (OrienX010) is a genetically engineered from Chinese patients oral separation of wild type 1 herpes simplex virus (HSV) as the carrier insert GM-CSF gene therapy drug.After gene recombination technology successively removing ICP34.5, ICP47 and insert the deactivation ICP6 gene, and at the site of the original ICP34.5 insert guided by IE promoter of hCMV human gm-csf gene.The drug after tumor site local injections of dosing, on the one hand, because of the soluble tumor characteristics of herpes simplex virus, reconstructing it after HSV-1 virus carrier at the injection site specific "soluble tumor" kill tumor cells;Viral vector expressed in tumor site, on the other hand, to produce high concentrations of GM-CSF enhance the antitumor immune function, play "beside the destruction effect", have inhibition effect on the distant metastases.
Detailed description
Subjects were tested drugs within 8 x 107 pfu/ml tumor injection treatment, the injection quantity according to tumor lesion size, injection amount shall not exceed 10 ml each time, injection frequency for every 2 weeks, 4 times per cycle treatment, treatment 2 cycles. Completed at the end of the second cycle after curative effect evaluation, such as the researchers determine continue to medicine can bring benefit to the subjects, can continue to offer benefits to the subjects' potential drug until disease progression, smaller, not tolerance toxicity or participants to withdraw consent.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Melanoma Standard solution phase failure Ⅳ M1c malignant melanoma spread to the liver
Key inclusion criteria (4 listed)
- By histological and/or cytology diagnosis Ⅳ M1c malignant melanoma patients with liver metastasis, the lack of an effective method for the conventional or the failure of conventional therapy or recurrence
- General physical status score (ECOG) 0-2 points
- Lifetime is expected to more than 4 months
- Always anti-tumor treatment (including/radiation therapy, immune therapy, targeted therapy, endocrine therapy, etc.) to end more than 4 weeks (using the nitroso urea class and mitomycin chemotherapy drug withdrawal over 6 weeks), and always treat the adverse reaction of restored or stability
Key exclusion criteria (4 listed)
- In the group treated with other experimental drugs within 4 weeks before, but in the intervening clinical research (except such as epidemiological studies)
- In group of four weeks before received the treatment of herpes simplex virus, such as acyclovir, ganciclovir, respectively.there is galloway, vidarabine, etc
- In group of four weeks before too much surgery
- Screening stage HSV - 1 antibody IgG and IgM are negative
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 |
|---|---|---|
| OrienX010Beijing biological technology co., LTD. Research and development of the source and force of recombinant human GM-CSF herpes simplex virus injection (OrienX010), is a genetically engineered type 1 herpes simplex virus (HSV - 1) as the carrier insert GM-CSF gene therapy drug.Its carrier is made of isolated from patients with oral Chinese wild single blister virus type I (CL1), after gene recombination technology successively removing ICP34.5, ICP47 and insert the deactivation ICP6 gene, and at the site of the original ICP34.5 insert guided by IE promoter of hCMV human GM-CSF gene. | Biological | – |
Primary outcome
change of tumor size
Time frame: 16 weeks
According to RECIST1.1 method to evaluate the change of tumor size.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2017.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma, run by OrienGene Biotechnology Ltd. at 1 site in China.
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 4 inclusion and 4 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 2 Oct 2017. 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 China. 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.
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?
Contact Zinan Xiao, MD (+86-15101193329, znxiao@Oriengene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of tumor size (time frame: 16 weeks). 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 2 Oct 2017.