NCT04973683

AL101 Before Surgery for the Treatment of Notch Activated Adenoid Cystic Cancer

AL101 Prior to Standard-of-Care Surgery in Patients With Notch Activated Adenoid Cystic Carcinoma (ACC)

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase Ib trial studies the side effects and possible benefits of AL101 before surgery in treating patients with notch activated adenoid cystic cancer. AL101 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving AL101 before surgery may help to control adenoid cystic cancer that has a NOTCH pathway activation.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the safety and feasibility of AL101 administered weekly for 6 to 8 weeks in the preoperative setting using National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. II. To determine the differences between NICD1 levels by immunohistochemistry (IHC) in the post-treatment surgical specimens as compared to baseline in patients treated with AL101. SECONDARY OBJECTIVES: I. To evaluate the objective response rate (ORR) to AL101 by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at 6 to 8 weeks. II. To assess percentage of patients undergoing the initially proposed surgery. III. To assess percentage of viable tumor cells in the surgical specimen (pathologic response) following AL101 treatment. EXPLORATORY OBJECTIVE: I. To evaluate pre- and post- treatment tumor and blood biomarkers and correlate with clinical and pathologic response and toxicity. OUTLINE: Patients receive AL101 intravenously (IV) over 60 minutes once weekly (QW) for 6-8 weeks in the absence of disease progression or unacceptable toxicity. Within 24-72 hours after the last infusion of AL101, patients undergo surgery per standard of care. Patients may continue AL101 after surgery at the discretion of the study doctor. After completion of study, patients are followed up within 6 weeks after surgery or within 30 days after last dose of AL101, and then every 6 months thereafter.

Conditions

• Adenoid Cystic Carcinoma
• Metastatic Adenoid Cystic Carcinoma

Interventions

Type	Name	Description
DRUG	AL101	Given IV
PROCEDURE	Therapeutic Conventional Surgery	Undergo standard of care surgery

Timeline

• Start date: 2021-09-30
• Primary completion: 2025-12-15
• Completion: 2025-12-15
• First posted: 2021-07-22
• Last updated: 2025-10-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study