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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Evaluate the safety and tolerability of escalating doses of intratumoral injection of VRT106. — About 2 years Incidence rate of TEAE
Characterize the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) levels. — About 2 years Incidence rate of DLT
Trial sites (3)
Facility
City
Region
Status
Sun Yat-sen University Cancer Center
Guangzhou
Guangdong
Recruiting
Affiliated Cancer Hospital of Zhengzhou University
Zhengzhou
Henan
Recruiting
Affiliated Cancer Hospital of Shandong First Medical University
Jinan
Shandong
Recruiting
More Guangzhou Virotech Pharmaceutical Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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