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A Phase 2, Open-Label, Multi-Center Study of Al101 (BMS-906024) in Patients with Adenoid Cystic Carcinoma (ACC) Bearing Activating Notch Mutations
This is a Phase 2, non-comparative, open-label, multicenter study of AL101 in patients with recurrent or metastatic ACC who harbor NOTCH 1,2,3,4 activating mutations.
To assess the clinical activity of AL101(BMS-906024) using radiographic assessments and RECIST v1.1 in ACC patients with activating Notch mutations. To confirm safety and tolerability of AL101 in ACC patients with activating Notch mutations. To obtain a set of population parameters and to identify covariates that affect systemic exposure to AL101 and metabolite(s). To establish correlation between positive NICD1 stain and Notch1 mutations. To establish the correlation between mutations in Notch and associated genes and response or resistance to study drug.
AL101 (); BMS-906024 (AL101)