A Phase 2, Open-Label, Multi-center Study of AL101 in Patients With Adenoid Cystic Carcinoma (ACC) Bearing Activating Notch Mutations
Description
Brief 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
Phase
N/AInclusion and Exclusion 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.
- 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
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.
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