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
Qualifiers
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
Treatments tested in this trial
- VRT106
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov