Clinical trial · Interventional
A Study of Recombinant Oncolytic Virus M1(VRT106) in Patients With Solid Tumors
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Biodistribution Characteristics, Biological Effects and Initial Efficacy of Recombinant Oncolytic Virus M1 for Injection (VRT106) in the Treatment of Patients With Locally Advanced or Metastatic Solid Tumors
NCT06368921CI-TRIAL-00099868recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| VRT106 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- VRT106
- description
- VRT106
- interventionNames
- Biological: VRT106
Primary outcomes (2)
- measure
- Evaluate the safety and tolerability of escalating doses of intratumoral injection of VRT106.
- timeFrame
- About 2 years
- description
- Incidence rate of TEAE
- measure
- Characterize the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) levels.
- timeFrame
- About 2 years
- description
- Incidence rate of DLT
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.