Solid Tumor Clinical Trial
Official title:
A Phase 1 Open-Label Study of Genetically Engineered Oncolytic HSV-1 (C5252) Expressing IL-12 and Anti-PD-1 Antibody in Patients With Recurrent or Progressive Glioblastoma
This is a Phase 1 open label, first in human study of C5252 monotherapy designed to determine the safety and tolerability of a single intratumoral (IT) injection of C5252 in patients with recurrent or progressive glioblastoma (GBM).
This is a Phase 1 open label, first in human study of C5252 monotherapy designed to determine the safety and tolerability of a single IT injection of C5252 in patients with recurrent or progressive GBM. The Part 1 portion of the study is a 3+3 design to evaluate escalating doses of C5252. Total enrollment will depend on the toxicities and/or activity observed, with approximately 36 evaluable participants enrolled. Once the recommended dose (RD) is identified from Part 1, Part 2 Dose Expansion will enroll up to 15 additional participants to further assess the safety, tolerability, and preliminary efficacy of a single IT injection of C5252 monotherapy. ;
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