Completed

ACCURACYA Phase 2, Open-Label, Multi-center Study of AL101 in Patients With Adenoid Cystic Carcinoma (ACC) Bearing Activating Notch Mutations

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What is being tested

AL101

Drug
Who is being recruted

Adenocarcinoma+3

+ Carcinoma

+ Carcinoma, Adenoid Cystic

Over 18 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: December 2018
See protocol details

Summary

Principal SponsorAyala Pharmaceuticals, Inc,
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 14, 2018

Actual date on which the first participant was enrolled.

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

Official TitleA Phase 2, Open-Label, Multi-center Study of AL101 in Patients With Adenoid Cystic Carcinoma (ACC) Bearing Activating Notch Mutations
NCT03691207
Principal SponsorAyala Pharmaceuticals, Inc,
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

87 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AdenocarcinomaCarcinomaCarcinoma, Adenoid CysticNeoplasmsNeoplasms by Histologic TypeNeoplasms, Glandular and Epithelial

Criteria

4 inclusion criteria required to participate
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.
7 exclusion criteria prevent from participating
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.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 17 locations

Suspended

USC Norris Comprehensive Cancer center

Los Angeles, United StatesOpen USC Norris Comprehensive Cancer center in Google Maps
Suspended

University of Colorado Cancer Center

Aurora, United States
Suspended

Sylvester Comprehensive Cancer Center

Miami, United States
Suspended

H. Lee Moffitt Cancer Center & Research Institute

Tampa, United States
Completed17 Study Centers