NCT03691207

A Study Of AL101In Patients With Adenoid Cystic Carcinoma (ACC) Bearing Activating Notch Mutations

A Phase 2, Open-Label, Multi-center Study of AL101 in Patients With Adenoid Cystic Carcinoma (ACC) Bearing Activating Notch Mutations

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: Ayala Pharmaceuticals, Inc, · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. The study includes 2 cohorts, ran in a sequential fashion: Cohort 1 - AL101 4 mg once weekly (QW) intravenously (IV) Cohort 2 - AL101 6 mg QW IV

Conditions

• Adenoid Cystic Carcinoma

Interventions

Type	Name	Description
DRUG	AL101	AL101 is a small-molecule that inhibits gamma secretase, an enzyme which plays a key role in the activation of the Notch signaling pathway by releasing the Notch intracellular domain (NICD) of all four Notch receptors from the membrane. In patients with aberrant Notch signaling, AL101 may inhibit Notch signaling and potentially impede tumor growth.The drug is administered intravenously

Timeline

• Start date: 2018-12-14
• Primary completion: 2022-07-15
• Completion: 2022-12-02
• First posted: 2018-10-01
• Last updated: 2024-01-31
• Results posted: 2024-01-31

Locations

17 sites across 6 countries: United States, Canada, France, Israel, Netherlands, United Kingdom

Regulatory

• FDA-regulated drug study