Trial Summary
What is the purpose of this trial?This trial studies the effects of AL101, a drug given through an IV drip, on patients with notch activated adenoid cystic cancer. The drug aims to stop the cancer cells from growing by blocking necessary enzymes. The goal is to see if AL101 can help control this specific type of cancer before surgery.
Eligibility Criteria
Adults with adenoid cystic carcinoma showing NOTCH1 pathway activation, who can consent to treatment and follow study rules. They must have a tumor that can be surgically removed and agree to use two forms of contraception if they're able to conceive. People with severe medical conditions, uncontrolled infections, or recent treatments for other cancers are excluded.Inclusion Criteria
Total bilirubin > 1.5 upper limit of normal (ULN) (except known Gilbert's syndrome)
You are capable of giving informed consent.
My doctor believes my cancer can be surgically removed, either to try to cure it or to control its spread.
+13 more
Exclusion Criteria
You have had an allergic reaction or are allergic to the ingredients in the investigational product.
I had cancer treatment at least 4 weeks ago for a local recurrence.
I have been treated with a gamma-secretase inhibitor before.
+8 more
Participant Groups
The trial is testing AL101's effectiveness when given before surgery in patients with notch activated adenoid cystic cancer. It aims to see if AL101 can halt tumor growth by inhibiting certain enzymes needed for cell proliferation.
1Treatment groups
Experimental Treatment
Group I: Treatment (AL101)Experimental Treatment2 Interventions
Patients receive AL101 IV over 60 minutes 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
M D Anderson Cancer CenterHouston, TX
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Who Is Running the Clinical Trial?
M.D. Anderson Cancer CenterLead Sponsor