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

Guangzhou Virotech Pharmaceutical

Status and phase

Enrolling

Phase 1

Conditions

Solid Tumor

Treatments

Biological: VRT106

Study type

Interventional

Funder types

Industry

Identifiers

NCT06368921

VRT106-C01

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.