NCT06589609

Phase 1 Clinical Trial of FluBHPVE6E7 Immunotherapy for HPV16-Associated Oropharyngeal Cancer

A Phase 1 Study of FluBHPVE6E7 Immunotherapy in Patients With HPV16- Associated Oropharyngeal Squamous Cell Carcinoma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: BlueSky Immunotherapies GmbH · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

A clinical study of an immunotherapy in patients with head or neck cancers associated with the HPV16 virus

Detailed description

Squamous cell carcinomas of the head and neck (HNSCC) rank as the sixth most common cancer globally, with approximately 575,000 new cases diagnosed each year. In recent years, there has been a rising incidence in younger patients who have limited exposure to traditional risk factors such as smoking and alcohol. This increase is closely associated with HPV infection, particularly HPV-16, which is strongly linked to oropharyngeal cancer. Treatment for HPV-positive oropharyngeal squamous cell carcinoma (OPSCC) is highly individualized, depending on the disease stage, patient comorbidities, and personal preferences. In this phase 1 study, patients with HPV-16-associated OPSCC are being treated with the immunotherapeutic delNS-vector expressing the HPV-16 oncogenes E6 and E7, administered both intratumorally and intramuscularly.

Conditions

• Oropharyngeal Squamous Cell Carcinoma (SCC)

Interventions

Type	Name	Description
BIOLOGICAL	FluBHPVE6E7	Intratumoral administration for first dose followed by intramuscular administration for subsequent doses at recommended dose level and determined schedule.

Timeline

• Start date: 2024-08-23
• Primary completion: 2027-11-01
• Completion: 2029-11-01
• First posted: 2024-09-19
• Last updated: 2024-09-19

Locations

1 site across 1 country: Austria