Trial | NCT03691207  Report issue

Title

A Study Of AL101 In 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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    87
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.
Study Started
Dec 14
2018
Primary Completion
Oct 31
2022
Anticipated
Study Completion
Dec 31
2022
Anticipated
Last Update
Dec 14
2021

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

  • Other names: BMS 906024

SINGLE-ARM Experimental

AL101 is an inhibitor of gamma secretase-mediated Notch signaling.

Criteria 

Inclusion Criteria:

Confirmed Adenoid Cystic Carcinoma with known NOTCH 1/2/3/4 activating mutation that is recurrent or metastatic, not amenable to potentially curative surgery or radiotherapy.
Evidence of radiographic or clinical disease progression within 6-months of signing informed consent; newly diagnosed metastatic patients will be allowed.
Patients must have Formalin-fixed, Paraffin-embedded tissue available .
Must have at least 1 target lesion that is measurable for patients with nodal or visceral metastasis.

Exclusion Criteria:

Diagnosed with a malignancy other than ACC in the past 2 years.
Uncontrolled, Active Infection
Gastrointestinal (GI) disease with increased risk of diarrhea [e.g. inflammatory bowel disease (IBD)]
Symptomatic central nervous system (CNS) metastases.
Unstable or severe uncontrolled medical condition
Eastern Cooperative Oncology Group (ECOG) performance status ≥2.
Abnormal organ and marrow function
No Results Posted