drugset / Trial / NCT05235074

OH2 Oncolytic Viral Therapy in Central Nervous System Tumors

NCT05235074

Phase 1/2 Recruiting 28 enrolled Binhui Biopharmaceutical Co., Ltd.
NaSingle-groupOpen-labelTreatment

Summary

In the first phase, it mainly explores the safety, tolerability and preliminary effectiveness of two doses of OH2 injection in the treatment of patients with recurrent central nervous system tumors; to evaluate the biodistribution and virus shedding of OH2 injection administered in the tumor cavity; to evaluate the level of anti-HSV2 antibody in patients when OH2 injection is administered intracavitary to tumor; to determine the phase II recommended dose (RP2D) of OH2 injection in the treatment of recurrent glioblastoma. Phase IIa, to evaluate the preliminary efficacy of OH2 injection in the treatment of patients with recurrent glioblastoma after surgery, and to further evaluate the safety of OH2 in the treatment of relapsed glioblastoma.

Timeline

Start
2021-11-16
Primary completion
2026-06-16
Completion
2026-06-16

Drugs

EvaluationDrugModalityDoseRoute
Subject OH2 Other / unclassified 1e+06 unknown Other
Subject OH2 Other / unclassified 1e+07 unknown Other