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VRT106

Hongyun Zhao

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.

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.

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

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

Measure the distribution and shedding of VRT106 following intratumoral injection using qPCR (quantitative polymerase chain reaction) method.

Detect the presence of neutralizing antibodies against VRT106, which represent the potency of the neutralizing antibodies, using the PD50 value.

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.

DCR is defined as the percentage of participants who have achieved CR, PR, or stable disease (SD) based on assessments by RECIST v1.1.

Guangzhou Virotech Pharmaceutical Co., Ltd.

M1-c6v1 will be administered through IV drip

M1-c6v1

Dr. Kojima Takashi, M.D.

Dr. Nishina Tomohiro, M.D.

Dr. Sunakawa, Yu, M.D.

A Phase I Study of the Safety and Tolerability of M1-c6v1 Administered Via Intravenously for Treatment of Patients With Locally Advanced or Metastatic Solid Tumors

This study is an open-label, dose-escalation clinical study which aims to evaluate the safety and tolerability of multiple IV injections of M1-c6v1 in subjects with locally advanced/metastatic solid tumors, as well as evaluating the biological distribution characteristics and biological effects of M1-c6v1 (i.e., virus tissue distribution and shedding characteristics), evaluating immunogenicity of M1-c6v1, and preliminarily exploring the anti-tumor effects of M1-c6v1.

A Study of Intravenous M1-c6v1 for Locally Advanced or Metastatic Solid Tumors

A Phase I, Open-label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Effects of M1-c6v1 for Treatment of Patients With Locally Advanced or Metastatic Solid Tumors

Monitor the incidence of adverse events (TEAEs) during the study.

Measure the distribution and shedding of M1-c6v1 following intravenous injection by detecting its presence in blood, saliva, urine, nasal swabs, and feces using qPCR (quantitative polymerase chain reaction) method.

Detect the presence of neutralizing antibodies against M1-c6v1 and assess their titers, which represent the potency of the neutralizing antibodies, using the PD50 value.

Based on the specific tumor types, assess the ORR (Objective Response Rate) and DCR (Disease Control Rate) using RECIST (Response Evaluation Criteria in Solid Tumors) v1.1 or mRECIST (modified Response Evaluation Criteria in Solid Tumors) criteria.

Spots Global Cancer Trial Database for vrt106

Every month we try and update this database with for vrt106 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Recombinant Oncolytic Virus M1(VRT106) in Patients With Solid Tumors	NCT06368921	Solid Tumor	VRT106	18 Years - 75 Years	Guangzhou Virotech Pharmaceutical Co., Ltd.
A Study of Intravenous M1-c6v1 for Locally Advanced or Metastatic Solid Tumors	NCT06046742	Solid Tumor	M1-c6v1	18 Years -	Guangzhou Virotech Pharmaceutical Co., Ltd.
A Study of Intravenous M1-c6v1 for Locally Advanced or Metastatic Solid Tumors	NCT06046742	Solid Tumor	M1-c6v1	18 Years -	Guangzhou Virotech Pharmaceutical Co., Ltd.

Spots Global Cancer Trial Database for vrt106

Every month we try and update this database with for vrt106 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for vrt106 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.