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

Status:	Recruiting
Healthy:	No
Age Range:	18 - Any
Updated:	3/9/2019
Start Date:	December 14, 2018
End Date:	July 2021
Contact:	Andrea Vergara-Silva, Dr.
Email:	ClinicalTrials.gov_Accuracy@ayalapharma.com
Phone:	+1-857-444-0553

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

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

Inclusion Criteria:

1. 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.

2. Evidence of radiographic or clinical disease progression within 6-months of signing
informed consent; newly diagnosed metastatic patients will be allowed.

3. Patients must have Formalin-fixed, Paraffin-embedded tissue available .

4. Must have at least 1 target lesion that is measurable for patients with nodal or
visceral metastasis.

Exclusion Criteria:

1. Diagnosed with a malignancy in the past 2 years.

2. Infection

3. Gastrointestinal (GI) disease with increased risk of diarrhea [e.g. inflammatory bowel
disease (IBD)]

4. Symptomatic central nervous system (CNS) metastases.

5. Unstable or severe uncontrolled medical condition

6. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.

7. Abnormal organ and marrow function

We found this trial at

sites

Fred Hutchinson Cancer Research Center

1100 Fairview Avenue North
Seattle, Washington 98109

(206) 667-5000