NCT04616443

OH2 Injection in Combination With HX008 for Melanoma.

Phase Ib Study of the Combination Use of Recombinant Human GM-CSF Type II Herpes Simplex Virus (OH2) Injection (Vero Cells) and HX008 Injection in the Treatment of Melanoma

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Binhui Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This phase Ib study evaluates the safety and efficacy of OH2 in combination with HX008, an anti-PD-1 antibody, in patients with 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.

Detailed description

The trial is a phase Ib study evaluating the safety and efficacy of OH2 injection combined with HX008 injection in patients with Melanoma. In the Phase Ib dose escalation trial, two doses (1x10e6, 1x10e7 CCID50/mL) of OH2 will be combined with HX008(at a fixed dose of 200mg) will be tested. In the Phase Ib dose expansion trial, OH2(1x10e7 CCID50/mL) will be injected individually in the first week, followed by every two weeks while HX008(200 mg) will be injected every three weeks after the first injection which will be in the second week. Blood samples will be collected and radiological imaging will be performed to evaluate safety and efficacy during the trial. Besides, patients will be subjected to cutaneous swabs, and blood/urine/feces sampling to determine virus shedding. Participating patients will be evaluated for objective response rate, progression free survival and overall survival.

Conditions

• Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	OH2 injection	Oncolytic Type 2 Herpes Simplex Virus
BIOLOGICAL	HX008 injection	Recombinant humanized anti-PD-1 monoclonal antibody of injection

Timeline

• Start date: 2020-12-01
• Primary completion: 2025-11-30
• Completion: 2025-11-30
• First posted: 2020-11-05
• Last updated: 2025-07-24

Locations

1 site across 1 country: China