Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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.
Phase
Phase 2
Funding Agency/Sponsor
Industrial
Disease
Head and Neck Cancer
Enrollment Eligibility
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 other than ACC in the past 2 years.
2. Uncontrolled, Active 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 ≥2.
7. Abnormal organ and marrow function