Clinical trial NCT06368921: A Study of Recombinant Oncolytic Virus M1(VRT106) in Patients With Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Solid Tumor
Lead sponsor: Guangzhou Virotech Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-04-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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.

Primary outcomes:
measure: Evaluate the safety and tolerability of escalating doses of intratumoral injection of VRT106.
timeFrame: About 2 years
measure: Characterize the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) levels.
timeFrame: About 2 years
Secondary outcomes:
measure: Examine the biological distribution characteristics and shedding patterns of intratumoral injection of VRT106.
timeFrame: About 2 years
measure: Assess the immunogenicity of intratumoral injection of VRT106.
timeFrame: About 2 years
measure: Assess the anti-tumor effect of VRT106, including objective response rate (ORR) as efficacy indicators.
timeFrame: About 2 years
measure: Assess the anti-tumor effect of VRT106, including disease control rate (DCR) as efficacy indicators.
timeFrame: About 2 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Zhengzhou
country: China
facility: Affiliated Cancer Hospital of Zhengzhou University
state: Henan
city: Jinan
country: China
facility: Affiliated Cancer Hospital of Shandong First Medical University
state: Shandong
Study officials:
References: