Phase I clinical trial of a recombinant oncolytic virus injection combined with PD-1 antibody-based gene therapy for recurrent head and neck cancer in China: An open-label study.

ABSTRACT: This study aims to evaluate the safety and preliminary efficacy of VT1093, an oncolytic recombinant herpes simplex virus type 1 (HSV-1) engineered to express a PD-1 monoclonal antibody, for the treatment of recurrent head and neck cancer. This open-label, single-arm, dose-escalation Phase I clinical trial was an exploratory dose-escalation study, in which the dose is progressively increased in enrolled patients until either the maximum tolerated dose (MTD) or dose-limiting toxicity (DLT) is identified. Seven patients with recurrent head and neck cancer were recruited at Beijing Tongren Hospital. Patients received either a single or multiple intratumoral injections of VT1093. For the single-dose group, patients were monitored for 28 days after treatment. For the multiple-dose group, three t

SUBMITTER: Zhu S 

PROVIDER: S-EPMC12581721 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature