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Oncology company Ayala Pharmaceuticals announced today that phase II TENACITY clinical trials for patients with the selective small molecule AL101 to treat relapse or metastatic (R/M) triple negative breast cancer (TNBC) activated by the Notch signal path, have been officially launched.
Phase II study aims to assess the efficacy and safety of AL101 as a monotherapy for Notch-activated R/M TNBC patients.
this is an open, multi-center, one-arm study that is expected to initially recruit 26 Notch-activated R/M TNBC patients whose disease has relapsed or progressed after previous treatment.
will use second-generation sequencing (NGS) to determine The activation status of Notch.
Ayala expects to report preliminary data by the end of 2021.
AL101 is a small molecule γ secretion enzyme inhibitor (GSI) in the study designed to selectively inhibit Notch 1, 2, 3 and 4.
AL101 is designed to inhibit the expression of notch γ target gene by blocking the secretion enzymes needed to activate Notch.
previously, AL101 had been awarded "Fast Track Qualification" and "Orphan Drug Title" by the FDA to treat adenoblast-like cystic cancer (ACC).