Using a virus to treat 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
This study is testing whether a new virus treatment can safely help people with advanced solid tumors by seeing how well it works and how much can be given.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Guangzhou Virotech Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 3 sites (Guangzhou, Guangdong and 2 other locations) |
| Trial ID | NCT06368921 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and tolerability of intratumoral injections of the recombinant oncolytic virus M1 (VRT106) in patients with locally advanced or metastatic solid tumors. It is an open-label, dose-escalation study that aims to assess the biological distribution and effects of VRT106, including its immunogenicity and preliminary anti-tumor effects. Participants will receive either single or multiple injections of the virus to determine the optimal dosing and safety profile.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with locally advanced or metastatic solid tumors that are intolerable or refractory to standard treatments.
Not a fit: Patients who have received anti-tumor treatments within 4 weeks prior to the trial or those with a history of immunodeficiency may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a novel therapeutic option for patients with solid tumors that are resistant to standard therapies.
How similar studies have performed: While oncolytic virus therapies are an emerging field, this specific approach with VRT106 is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guangzhou, Guangdong and 2 other locations
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
- Affiliated Cancer Hospital of Zhengzhou University — Zhengzhou, Henan, China (Recruiting)
- Affiliated Cancer Hospital of Shandong First Medical University — Jinan, Shandong, China (Recruiting)
Study contacts
- Study coordinator: Hongyun Zhao
- Email: zhaohy@syscc.org.cn
- Phone: 020-87343565
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.