fostroxacitabine bralpamide (MIV-818)

P1/2, N=53, Active, not recruiting, Medivir | Trial completion date: Feb 2024 --> Jun 2025 | Trial primary completion date: Feb 2024 --> Dec 2024

Background: Fostroxacitabine bralpamide (fostrox) is an orally administered liver-targeted troxacitabine-based nucleotide prodrug currently undergoing phase 1/2a clinical trial in advanced hepatocellular carcinoma (HCC), in combination with pembrolizumab or lenvatinib (NCT03781934). The triple combination of fostrox with anti-PD1 and lenvatinib showed enhanced efficacy in a nonclinical tumor model, and changes in TILs were consistent with increased immune-mediated anti-tumor activity. The results indicate a potential for increased anti-tumor efficacy using a triple combination of fostrox plus checkpoint inhibition and anti-angiogenic therapy.1The study was approved by the Institutional Animal Care and Use Committee (IACUC) of CrownBio UK, and conducted in accordance with the regulations of the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC)