A Study of Recombinant Oncolytic Virus M1(VRT106) in Patients With Solid Tumors
ConditionSolid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGuangzhou Virotech Pharmaceutical Co., Ltd.
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
VRT106
Biological/Vaccineintratumoral injection
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: VRT106Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Evaluate the safety and tolerability of escalating doses of intratumoral injection of VRT106.
Incidence rate of TEAE
Time frame
About 2 years2
Characterize the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) levels.
Incidence rate of DLT
Time frame
About 2 yearsSecondary outcomes
1
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.
Time frame
About 2 years2
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.
Time frame
About 2 years3
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.
Time frame
About 2 years4
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.
Time frame
About 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov