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Trial Title:
A Study of Recombinant Oncolytic Virus M1(VRT106) in Patients With Solid Tumors
NCT ID:
NCT06368921
Condition:
Solid Tumor
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
VRT106
Description:
intratumoral injection
Arm group label:
VRT106
Summary:
To Evaluate the safety and tolerability of single and multiple intratumoral injections of
recombinant oncolytic virus M1 (VRT106) in patients with locally advanced/metastatic
solid tumors.
Detailed description:
This study is an open-label, dose-escalation clinical study which aims to evaluate the
safety and tolerability of IT injections of VRT106 in subjects with locally
advanced/metastatic solid tumors, as well as evaluating the biological distribution
characteristics and biological effects of VRT106 (i.e., virus tissue distribution and
shedding characteristics), evaluating immunogenicity of VRT106, and preliminarily
exploring the anti-tumor effects of VRT106.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Subject voluntarily agrees to participate in this study and signs an Institutional
Review Board -approved informed consent prior to performing any of the Screening
Visit procedures.
- Males and females at 18-75 years of age, inclusive, at the Screening Visit.
- Subjects must have histological or cytological diagnosis of locally advanced or
metastatic solid tumors who are intolerable or refractory to the standard therapy.
- Have at least one injectable lesion.
- An Eastern Cooperative Oncology Group (ECOG) score of 0-1.
- An estimated survival time of ≥ 12 weeks.
Exclusion Criteria:
- Subject has received any anti-tumor treatment 4 weeks before using the IMP.
- Subject has received any prior oncolytic viruses or other gene therapies.
- Subject has a history of primary or acquired immunodeficient states, leukemia,
lymphoma, acquired immunodeficiency syndrome (AIDS) or other clinical manifestations
of infection with human immunodeficiency viruses, and those on immunosuppressive
therapy.
- Subject has received immunomodulatory drugs, including but not limited to thymosin,
IL-2, IFN, etc. within 14 days prior to first administration of IMP.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Hongyun Zhao
Email:
zhaohy@syscc.org.cn
Start date:
April 2024
Completion date:
December 2025
Lead sponsor:
Agency:
Guangzhou Virotech Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Guangzhou Virotech Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06368921
