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

Phase 1

Recruiting

• Conditions: Oropharyngeal Squamous Cell Carcinoma (SCC)
• Interventions: Biological: FluBHPVE6E7

• Registration Number: NCT06589609
• Lead Sponsor: BlueSky Immunotherapies GmbH

Brief 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.

Study Timeline

• Study Start: 2024-08-23
• Status Verified: 2024-09
• Study First Submitted: 2024-09-06
• Study First Submitted QC: 2024-09-06
• Last Update Submitted: 2024-09-06
• Study First Posted: 2024-09-10
• Last Update Posted: 2024-09-10
• Primary Completion: 2027-11
• Study Completion: 2029-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	FluBHPVE6E7	FlubHPVE6E7

Primary Outcome Measures

Name	Time	Method
Frequency and severity of adverse events (AEs)	7 days	To assess the severity of the adverse event is assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.

Secondary Outcome Measures

Name	Time	Method
Intralesional T-cell infiltration	24 weeks	To assess the intralesional T-cell infiltration in tumour tissue available from surgery or biopsy by immunohistological staining.
Biodistribution	24 weeks	To evaluate the presence of FluBHPVE6E7 by quantification of FluBHPVE6E7 genome copies in nasal secretion samples by RT-qPCR (copies per ml blood).
Virus recovery in oropharyngeal secretion samples	7 days	To evaluate the presence of FluBHPVE6E7 by quantification of FluBHPVE6E7 genome copies in oropharyngeal secretion samples by RT-qPCR (copies per sample).
Virus recovery in saliva	7 days	To evaluate the presence of FluBHPVE6E7 by quantification of FluBHPVE6E7 genome copies in saliva samples by RT-qPCR (copies per sample).
Frequency and severity of adverse events (AEs)	24 weeks	To assess the severity of the adverse event according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.
Disease-free survival (DFS)	60 months	To assess the length of time after treatment during which the patient remains free from any signs or symptoms of the disease.
Overall survival (OS)	60 months	To assess the length of time from the start of treatment or diagnosis until the death of the patient from any cause.
Induction of HPV-specific T-cell response following FluBHPVE6E7 administration	24 weeks	To assess the induction of HPV16 E6- and E7-specific T-cells (%) by IFN-gamma ELISPOT analysis.
Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) following FluBHPVE6E7 administration	24 weeks	To assess the induction of systemic vector-specific antibodies by HAI assay.

Trial Locations

Locations (1)

Medical University Vienna; 🇦🇹 Vienna, Austria