Clinical trials
Full profile accessFollow clinical development from study design and recruitment through results.
- Trial phase
- Status
- Readouts
Drug intelligence / Profile preview
I-131-A8 (also known as I-131-bivatuzumab or I-131-BIWA 8) is a radiopharmaceutical consisting of the humanized monoclonal antibody **bivatuzumab** labeled with the radioisotope **Iodine-131**. Bivatuzumab is designed to target the variant 6 isoform of CD44 (**CD44v6**), a cell surface glycoprotein that is overexpressed in various squamous cell carcinomas, particularly head and neck squamous cell carcinoma (HNSCC). The therapeutic strategy involves the antibody binding to CD44v6-positive tumor cells and delivering localized beta-radiation from the I-131 isotope, which induces DNA double-strand breaks and subsequent apoptosis. Developed by **Boehringer Ingelheim**, I-131-A8 reached Phase I/II clinical trials. However, the development of bivatuzumab-based therapies was halted due to severe and sometimes fatal skin toxicities, specifically toxic epidermal necrolysis (TEN), which resulted from the expression of CD44v6 in normal skin keratinocytes.
Beyond the preview
Explore the evidence, development activity, and competitive landscape with Gosset’s full data platform.
Follow clinical development from study design and recruitment through results.
Explore development by indication, patient population, and geography.
Trace asset ownership, licensing agreements, and commercial partnerships.
Explore the patent landscape and regulatory exclusivity around an asset.
Compare development programs by target, modality, and indication.
Connect source evidence and development news to your research questions.
See how Gosset can support your research on I-131-bivatuzumab.