Spots Global Cancer Trial Database for Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of the Oncolytic HSV1 MVR-C5252

Study Description

Brief Summary: This is a Phase 1 open label study designed to assess the safety and tolerability of the oncolytic herpes simplex virus 1 (oHSV1) study drug, MVR-C5252, administered intratumorally by convection-enhanced delivery (CED) in patients with recurrent high-grade glioma. Once the safety and maximum tolerated dose (MTD) is established in the dose escalation portion of the trial, a dose expansion cohort at the recommended phase 2 dose (RP2D) in patients with isocitrate dehydrogenase (IDH) wildtype recurrent glioblastoma (GBM) will evaluate preliminary efficacy of the study drug.

Detailed Description: Oncolytic HSV1 (oHSV1) was the first viral vector studied in clinical trials to treat malignant glioma with positive outcomes for tolerability and potential clinical benefits. MVR-C5252 is a genetically modified next generation oHSV1 with an active domain of human IL-12 and Fab fragment of anti-PD-1 antibody. During viral replication, IL-12 and anti-PD-1 antibody are expressed and secreted into the tumor microenvironment, acting synergistically by increasing the T cell infiltration, converting the cold (immune suppressing) tumor to hot (immune active) tumor, and inducing anti-tumor specific immunity. This study is investigating if oHSV1 MVR-C5252 administered via CED can overcome the BBB (Blood Brain Barrier) in patients with recurrent high-grade glioma. This study will enroll patients in 4 Stages. In Stage 1, externalized Synchromed II pump will be used to deliver Gadoliunium followed by MVR-C5252 for a single administration on Day 1. Stage 2, two infusions will be administered-on days 1 and 28 via the internalized pump. For patients accrued on Stage 3, the second infusion of study drug (Cycle 1, infusion 2) will occur 7 ± 1 days after 1st infusion for a total of 6 cycles (12 infusions). Stage 4, the dose expansion portion of the study, will commence once a MTD/RP2D is established. Within Stage 4 the efficacy of the study drug, as measured by progression-free 6 months survival will be evaluated.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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