AL101 Before Surgery for Adenoid Cystic Carcinoma

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Gamma-secretase inhibitors

Disqualifiers: Uncontrolled infection, CNS metastases, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

How is the drug AL101 different from other treatments for adenoid cystic carcinoma?

AL101 is a novel drug being tested before surgery for adenoid cystic carcinoma, a rare type of cancer. Unlike traditional treatments that are mainly surgical, AL101 may offer a new approach by targeting specific pathways in cancer cells, potentially improving outcomes for patients with this challenging condition.¹ ² ³ ⁴ ⁵

Research Team

Renata Ferrarotto

Principal Investigator

M.D. Anderson Cancer Center

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.

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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.

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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive AL101 intravenously over 60 minutes once weekly for 6-8 weeks

6-8 weeks

6-8 visits (in-person)

Surgery

Participants undergo surgery per standard of care within 24-72 hours after the last infusion of AL101

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks after surgery, then every 6 months

Treatment Details

Interventions

AL101
Therapeutic Conventional Surgery

Trial Overview 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.

Participant Groups

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.