A Phase I Clinical Trial of Repeated Dose Intrapleural Adenoviral-Mediated Interferon-beta (BG00001, Ad.hIFN-β for Pleural Malignancies
Ad.hIFN-β (BG00001) is a replication-defective recombinant adenoviral vector containing the
human interferon-beta (hIFN-β) gene. This Phase I study is designed to evaluate the safety
and maximum tolerated dose (MTD) of two doses of intrapleural (IP) Ad.hIFN-β in subjects
with pleural malignancies either metastatic or pleural mesothelioma.
Five dose levels will be studied:
- Dose levels 1, 2, and 3 will be given on Days 1 and 15
- Dose levels 4 and 5 will be given on Days 1 and 8
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine toxicity of two doses of intrapleural BG00001 (Ad.hIFN-β over 8 days, and
Through Day 85
Daniel H. Sterman, M.D.
University of Pennsylvania
United States: Food and Drug Administration
|Hospital of the University of Pennsylvania||Philadelphia, Pennsylvania 19104|