NCT04386967

OH2 Injection in Solid Tumors

Open and Incremental Phase I Clinical Trial of Recombinant Human GM-CSF Type II Herpes Simplex Virus (OH2) Injection (Vero Cells) in the Treatment of Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Binhui Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This phase I study evaluates the safety and efficacy of OH2 as single agent or in combination with Keytruda, an anti-PD-1 antibody, in patients with malignant solid tumors (Melanoma). 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.

Conditions

• Solid Tumor
• Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	OH2 injection	Oncolytic Type 2 Herpes Simplex Virus
DRUG	Keytruda	Anti-PD-1 antibody

Timeline

• Start date: 2018-11-22
• Primary completion: 2026-03-13
• Completion: 2026-12-13
• First posted: 2020-05-13
• Last updated: 2025-07-25

Locations

1 site across 1 country: China