Advanced Malignant Solid Tumor Clinical Trial
Official title:
A Dose Ascending, Open Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of VG161 in Subjects With Advanced Malignant Solid Tumors
VG161 is a recombinant human-IL12/15/PDL1B oncolytic HSV-1 Injectable. This Phase I study will be conducted in HSV-seropositive subjects with advanced malignant solid tumors that are refractory to conventional therapies. This is an open label study to determine the safety and tolerability of VG161, and recommended dose of VG161 for Phase II trials.
The trial will be conducted in 7 dose ascending cohorts, including 3 single dose accelerated titration design pilots and 4 multiple dose escalation groups. Descriptive statistics will be used to summarize all data. ;
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