A Phase I-c Study of Recombinant GM-CSF Herpes Simplex Virus to TreatⅣ M1c

• Conditions: Melanoma

• Registration Number: NCT03048253
• Lead Sponsor: OrienGene Biotechnology Ltd.

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.

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 Timeline

• Study Start: 2016-03-29
• Status Verified: 2017-02
• Study First Submitted: 2017-02-03
• Study First Submitted QC: 2017-02-06
• Study First Posted: 2017-02-09
• Last Update Submitted: 2017-09-29
• Last Update Posted: 2017-10-02
• Primary Completion: 2017-10-10
• Study Completion: 2019-10-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
change of tumor size	16 weeks	According to RECIST1.1 method to evaluate the change of tumor size.

Trial Locations

Locations (1)

Beijing cancer hospital; 🇨🇳 Beijing, Beijing, China