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

Solid Tumor Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06368921
• Other study ID #: VRT106-C01
• Status: Recruiting
• Phase: Phase 1
• Start date: April 2024
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: Guangzhou Virotech Pharmaceutical Co., Ltd.
• Contact: Hongyun Zhao
• Phone: 020-87343565
• Email: zhaohy[@]syscc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

Biological:
• VRT106
intratumoral injection

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou Virotech Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the safety and tolerability of escalating doses of intratumoral injection of VRT106.	Incidence rate of TEAE	About 2 years
Primary	Characterize the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) levels.	Incidence rate of DLT	About 2 years
Secondary	Examine the biological distribution characteristics and shedding patterns of intratumoral injection of VRT106.	Measure the distribution and shedding of VRT106 following intratumoral injection using qPCR (quantitative polymerase chain reaction) method.	About 2 years
Secondary	Assess the immunogenicity of intratumoral injection of VRT106.	Detect the presence of neutralizing antibodies against VRT106, which represent the potency of the neutralizing antibodies, using the PD50 value.	About 2 years
Secondary	Assess the anti-tumor effect of VRT106, including objective response rate (ORR) as efficacy indicators.	ORR is defined as the proportion of participants who have a partial response (PR) or complete response (CR) to intervention, based on assessments by RECIST v1.1.	About 2 years
Secondary	Assess the anti-tumor effect of VRT106, including disease control rate (DCR) as efficacy indicators.	DCR is defined as the percentage of participants who have achieved CR, PR, or stable disease (SD) based on assessments by RECIST v1.1.	About 2 years