aprutumab ixadotin (BAY1187982) / Bayer - LARVOL DELTA

Phase I study of fibroblast growth factor receptor 2 antibody-drug conjugate (FGFR2-ADC) BAY 1187982 in patients with advanced cancer (AACR 2017) - "Background: FGFR2-ADC (BAY 1187982) consists of an anti-FGFR2 antibody (BAY 1179470) and a stably linked, highly potent and non-cell permeable microtubule-binding auristatin toxophore. While this drug was tolerated well at lower dose levels, dose-limiting toxicities occurred below the expected therapeutic dose level. As the predicted human efficacious dose level based on the majority of animal models was above 0.4 mg/kg (Wittemer-Rump et al. AACR; Cancer Res 2015;75, 15 Suppl: Abstract nr 1683) a Phase II dose cannot be recommended and a successful clinical development of the compound was regarded as unlikely."

P1 data • Biliary Cancer • Biosimilar • Breast Cancer • Gastrointestinal Cancer • Oncology • Ophthalmology • Renal Disease • Venous Thromboembolism

First-in-Human Phase I Study of Aprutumab Ixadotin, a Fibroblast Growth Factor Receptor 2 Antibody-Drug Conjugate (BAY 1187982) in Patients with Advanced Cancer. (PubMed, Target Oncol) - P1 | "Aprutumab ixadotin was poorly tolerated, with an MTD found to be below the therapeutic threshold estimated preclinically; therefore, the trial was terminated early. CLINICALTRIALS."

Clinical • Journal • P1 data