A Study Of AL101 In Patients With Adenoid Cystic Carcinoma (ACC) Bearing Activating Notch Mutations

Official Title

A Phase 2, Open-Label, Single-Arm, Multi-Centre Study Of AL101 (BMS-906024) In Patients With Adenoid Cystic Carcinoma (ACC) Bearing Activating Notch Mutations

Summary:

This is a Phase 2, Simon 2-Stage optimal design, non comparative, open label, single-arm, multicentre study of AL101 in patients with recurrent or metastatic ACC who harbor NOTCH 1,2,3,4 activating mutations.

Trial Description

Primary Outcome:

• Objective response rate (ORR; complete response [CR] and partial response [PR]) by RECIST v1.1

• Frequency, duration and severity of adverse events (AEs) and serious adverse events (SAEs);

View this trial on ClinicalTrials.gov