Using a virus to treat solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.