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

NCT06589609 | Recruiting Phase 1 DMC

• 2 other identifiers: BS-032024-514413-36-00
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Oropharyngeal Squamous Cell Carcinoma (SCC)

Keywords

immunotherapy; Oropharyngal squamous cell carcinoma; HPV-16; Human papilloma virus; cancer; Head and neck cancer

Outcome Measures

Primary Outcomes (1)

• Frequency and severity of adverse events (AEs)

  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.

  7 days

Secondary Outcomes (9)

• Intralesional T-cell infiltration

  24 weeks

• Biodistribution

  24 weeks

• Virus recovery in oropharyngeal secretion samples

  7 days

• Virus recovery in saliva

  7 days

• Frequency and severity of adverse events (AEs)

  24 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

FlubHPVE6E7

Biological: FluBHPVE6E7

Interventions

FluBHPVE6E7 BIOLOGICAL

Intratumoral administration for first dose followed by intramuscular administration for subsequent doses at recommended dose level and determined schedule.

Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female or male patients, 18-65 years of age, with newly diagnosed, histologically confirmed p16- and HPV16-positive oropharyngeal squamous cell carcinoma with locoregional advanced disease including the following stages:
• T2N2-3, M0
• T3N0-3, M0
• T4N0-3, M0
• Primary tumour accessible for biopsy and intratumoural administration
• No evidence of distant metastatic disease (HPV16-positive secondary tumours are permissible)
• Karnofsky 100 - 70 (ECOG 0 or 1)
• Life expectancy of at least 6 months
• Normal screening ECG or screening ECG with no clinically significant findings requiring immediate treatment, as judged by the investigator
• Women of childbearing potential: Negative serum pregnancy test at screening
• Agree to use a reliable form of contraception until the end of the study treatment period.
• Provides written informed consent

You may not qualify if:

• Distant metastases
• Secondary, not HPV16-associated, malignancy
• History of malignancy other than the target malignancy to be investigated in this trial unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required during the study period
• Clinically significant out of range haematological, renal or hepatic laboratory tests which cannot be explained by the underlying disease
• Any vaccination within 1 week before day 0
• Active significant viral infections including influenza, CMV, and EBV within 4 weeks before receiving study treatment
• Co-infection with hepatitis B, hepatitis C, or HIV or having other immune deficient states
• Influenza-like illness (ILI) within 4 weeks before day 0
• Known hypersensitivity to Tamiflu or any of its components
• Pregnancy, breastfeeding
• Serious, concomitant disorder, including active systemic infection requiring treatment
• Proven or suspected systemic lupus erythematosus, thyroiditis, inflammatory bowel disease including Crohn's disease or multiple sclerosis
• Immunosuppression including any concurrent condition requiring the continued use of systemic steroids, or the use of immunosuppressive agents, disease modifying doses of anti-rheumatic drugs (e.g., azathioprine, cyclophosphamide, cyclosporine, methotrexate), and biologic disease modifying drugs such as TNF-α inhibitors (e.g. infliximab, adalimumab or etanercept). Corticosteroids must be discontinued \> 4 weeks prior to day 0 of study medication administration. Eye drops or ear drops containing corticosteroids are permissible.
• Prior major surgery within 4 weeks before day 0
• Any current significant cardiac, hepatic or renal disease or history of clinically significant, medically unstable disease (e.g. chronic renal failure; angina, myocardial ischemia or infarction, congestive heart failure, cardiomyopathy, or clinically significant arrhythmias)

Sponsors & Collaborators

• BlueSky Immunotherapies GmbH: lead

Study Sites (1)

Medical University Vienna

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Neoplasms; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms by Site

Central Study Contacts

Medical University of Vienna

CONTACT

+43140400; klin-pharmakologie@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: August 23, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2029
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)