Menu
Recruiting NCT06368921

A Study of Recombinant Oncolytic Virus M1(VRT106) in Patients With Solid Tumors

Phase I Interventional Solid Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: VRT106.
Who it may be relevant to
Registry conditions: Solid Tumor. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Biological VRT106
    intratumoral injection

Primary outcome measures

  • Evaluate the safety and tolerability of escalating doses of intratumoral injection of VRT106. [Time frame: About 2 years]
  • Characterize the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) levels. [Time frame: About 2 years]
Secondary outcome measures (4)
  • Examine the biological distribution characteristics and shedding patterns of intratumoral injection of VRT106. [Time frame: About 2 years]
  • Assess the immunogenicity of intratumoral injection of VRT106. [Time frame: About 2 years]
  • Assess the anti-tumor effect of VRT106, including objective response rate (ORR) as efficacy indicators. [Time frame: About 2 years]
  • Assess the anti-tumor effect of VRT106, including disease control rate (DCR) as efficacy indicators. [Time frame: About 2 years]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 3 centers
  • Sun Yat-sen University Cancer Center — Guangzhou
  • Affiliated Cancer Hospital of Zhengzhou University — Zhengzhou
  • Affiliated Cancer Hospital of Shandong First Medical University — Jinan

Identifiers

NCT: NCT06368921 · VRT106-C01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗