drugset / Trial / NCT03866525

OH2 Oncolytic Viral Therapy in Solid Tumors

NCT03866525

Phase 1/2 Recruiting 300 enrolled Binhui Biopharmaceutical Co., Ltd.
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2019-04-02
Primary completion
2025-08-30
Completion
2025-08-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Irinotecan Small molecule
Subject OH2 Other / unclassified 1e+06 unknown Other
Subject OH2 Other / unclassified 1e+07 unknown Other
Subject OH2 Other / unclassified 1e+08 unknown Other
Subject Pucotenlimab Monoclonal antibody