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

Ayala Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Adenoid Cystic Carcinoma

Treatments: Drug: AL101

Study type: Interventional

Funder types: Industry

Identifiers

NCT03691207

AL-ACC-01

Details and patient eligibility

About

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.

Full 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

Enrollment: 87 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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87 participants in 1 patient group

SINGLE-ARM

Experimental group

Description:

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

Treatment:

Drug: AL101