NCT06368921 A Study of Recombinant Oncolytic Virus M1(VRT106) in Patients With Solid Tumors
| NCT ID | NCT06368921 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Guangzhou Virotech Pharmaceutical Co., Ltd. |
| Condition | Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-06-19 |
| Primary Completion | 2026-09 |
Trial Parameters
Eligibility Fast-Check
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Brief 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.
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 immuno