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

NCT03691207 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: AL-ACC-01
• Study Type: interventional
• Target: 87
• Locations: 6 countries
• Sites: 17

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.

Conditions

Adenoid Cystic Carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  ORR is defined as partial response (PR) + complete response (CR) as assessed by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 for target lesions assessed by MRI. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

  3 years and 7 months

Secondary Outcomes (2)

• Clinical Benefit Response Rate (CBR)

  3 years and 7 months

• Overall Survival

  3 years and 5 months

Study Arms (1)

SINGLE-ARM

EXPERIMENTAL

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

Drug: AL101

Interventions

AL101 DRUG

AL101 is a small-molecule that inhibits gamma secretase, an enzyme which plays a key role in the activation of the Notch signaling pathway by releasing the Notch intracellular domain (NICD) of all four Notch receptors from the membrane. In patients with aberrant Notch signaling, AL101 may inhibit Notch signaling and potentially impede tumor growth.The drug is administered intravenously

Also known as: BMS 906024

SINGLE-ARM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ayala Pharmaceuticals, Inc,: lead

Study Sites (17)

USC Norris Comprehensive Cancer center

Los Angeles, California, 90033, United States

Location

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

Location

Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, 33612, United States

Location

University of Maryland School of Medicine

Baltimore, Maryland, 21201, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Mayo Clinic Hospital

Rochester, Minnesota, 55902, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

Hamilton Health Sciences Juravinski Cancer Centre

Hamilton, Ontario, L8V 1C3, Canada

Location

London Health Sciences Center

London, Ontario, N6A 5W9, Canada

Location

Institut Gustave Roussy

Villejuif, 94800, France

Location

Rabin Medical center

Petah Tikva, 49100, Israel

Location

Radboud University

Nijmegen, 6500, Netherlands

Location

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

Location

MeSH Terms

Conditions

Carcinoma, Adenoid Cystic

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Ayala Pharmaceuticals

info@ayalapharma.com

+1-857-444-0553

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label

Study Record Dates

• First Submitted: September 22, 2018
• First Posted: October 1, 2018
• Study Start: December 14, 2018
• Primary Completion: July 15, 2022
• Study Completion: December 2, 2022
• Last Updated: January 31, 2024
• Results First Posted: January 31, 2024

Record last verified: 2024-01

Locations

IL (1); US (10); GB (1); CA (3); NL (1); FR (1)