A Phase I-c Study of Recombinant GM-CSF Herpes Simplex Virus to TreatⅣ M1c
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
1 other identifier
observational
30
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2016
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 29, 2016
CompletedFirst Submitted
Initial submission to the registry
February 3, 2017
CompletedFirst Posted
Study publicly available on registry
February 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 10, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 28, 2019
CompletedOctober 2, 2017
February 1, 2017
1.5 years
February 3, 2017
September 29, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
change of tumor size
According to RECIST1.1 method to evaluate the change of tumor size.
16 weeks
Interventions
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.
Eligibility Criteria
Melanoma Standard solution phase failure Ⅳ M1c malignant melanoma spread to the liver
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing cancer hospital
Beijing, Beijing Municipality, 100010, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2017
First Posted
February 9, 2017
Study Start
March 29, 2016
Primary Completion
October 10, 2017
Study Completion
October 28, 2019
Last Updated
October 2, 2017
Record last verified: 2017-02