A phase I/II study of triple-mutated oncolytic herpes virus G47∆ in patients with progressive glioblastoma.

ABSTRACT: Here, we report the results of a phase I/II, single-arm study (UMIN-CTR Clinical Trial Registry UMIN000002661) assessing the safety (primary endpoint) of G47∆, a triple-mutated oncolytic herpes simplex virus type 1, in Japanese adults with recurrent/progressive glioblastoma despite radiation and temozolomide therapies. G47Δ was administered intratumorally at 3 × 10⁸ pfu (low dose) or 1 × 10⁹ pfu (set dose), twice to identical coordinates within 5-14 days. Thirteen patients completed treatment (low dose, n = 3; set dose, n = 10). Adverse events occurred in 12/13 patients. The most common G47Δ-related adverse events were fever, headache and vomiting. Secondary endpoint was the efficacy. Median overall survival was 7.3 (95%CI 6.2-15.2) months and the 1-year survival rate

SUBMITTER: Todo T 

PROVIDER: S-EPMC9304402 | biostudies-literature | 2022 Jul

REPOSITORIES: biostudies-literature