Clinical Trial

OH2 Oncolytic Viral Therapy in Solid Tumors

Recruiting Phase 1/2
View on ClinicalTrials.gov →
Record status
This record was last updated December 20, 2024 (before its estimated August 30, 2025 completion). Its status may not reflect the trial's current state.
Summary
This phase I/II study evaluates the safety and efficacy of OH2 as single agent or in combination with HX008, an anti-PD-1 antibody, in patients with malignant solid tumors (gastrointestinal cancers, head and neck cancers, soft tissue sarcomas). OH2 is an oncolytic virus developed upon genetic modifications of the herpes simplex virus type 2 strain HG52, allowing the virus to selectively replicate in tumors. Meanwhile, the delivery of the gene encoding human granulocyte macrophage colony-stimulating factor (GM-CSF) may induce a more potent antitumor immune response.
Protocol Amendment History 10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2019-03-05; most recent amendment 2024-12-19.
Status change: Not Yet Recruiting → Recruiting 2019-05-08
Trial Details
NCT Number NCT03866525
Lead Sponsor Binhui Biopharmaceutical Co., Ltd.
Conditions Solid Tumor, Gastrointestinal Cancer
Enrollment 300 participants
Start Date 2019-04-02
Primary Completion 2025-08-30 (estimated)
Study Completion 2025-08-30 (estimated)
Updated on ClinicalTrials.gov 2024-12-20