drugset
drugset / Trial / NCT03418480

HARE-40: HPV Anti-CD40 RNA vaccinE

NCT03418480 ↗

Phase 1/2 Completed 32 enrolled University of Southampton BioNTech SE · collab
Non-randomizedSingle-groupOpen-labelTreatment

Summary

HARE-40 is a phase I/II vaccine dose escalation study with two different arms: Arm 1A will perform intrapatient dose escalation in patients with previously treated HPV16+ Head \& Neck Cancer using two dose cohorts to establish a safe, tolerable and recommended dose of HPV vaccine. Arm 1B will perform intrapatient dose escalation in patients with advanced HPV16+ cancer (head and neck, anogenital, penile, cervical and other) using a single cohort to establish a safe, tolerable and recommended dose of HPV vaccine.

Timeline

Start
2017-04-11
Primary completion
2023-11-01
Completion
2024-01-24

Drugs

EvaluationDrugModalityDoseRoute
Subject BNT113 Vaccine — Other

Indications

cancer of unknown primary site head and neck neoplasm human papillomavirus-related squamous cell carcinoma penile cancer uterine cervix neoplasm