RecruitingPhase 1NCT06589609

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


Sponsor

BlueSky Immunotherapies GmbH

Enrollment

12 participants

Start Date

Aug 23, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This is a Phase 1 trial testing a new immunotherapy (FluBHPVE6E7) for people with advanced throat cancer (oropharyngeal cancer) caused by the HPV16 virus. The therapy aims to activate the immune system to fight the cancer by targeting viral proteins. **You may be eligible if...** - You are between 18 and 65 years old - You have a newly diagnosed, biopsy-confirmed HPV16-positive oropharyngeal (throat) squamous cell cancer at an advanced local stage (T2N2-3, T3N0-3, or T4N0-3, no distant spread) - Your tumor is accessible for biopsy and direct injection - Your general health is good (Karnofsky 70–100, ECOG 0 or 1) **You may NOT be eligible if...** - Your cancer has spread to distant organs - You have a second cancer not related to HPV16 - You had another cancer in the past 2 years (unless in full remission) - You are pregnant or breastfeeding - You have active viral infections (HIV, Hepatitis B/C, influenza, CMV/EBV) - You are taking immunosuppressive medications (steroids, methotrexate, TNF inhibitors, etc.) - You have an autoimmune condition such as lupus, multiple sclerosis, or Crohn's disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALFluBHPVE6E7

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


Locations(1)

Medical University Vienna

Vienna, Austria

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NCT06589609


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