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Adenoid Cystic CarcinomaPhase 1NCT04973683

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

A Phase 1 study testing AL101 and Therapeutic Conventional Surgery in people with Adenoid Cystic Carcinoma and Metastatic Adenoid Cystic Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
AL101 and Therapeutic Conventional Surgery
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteUnited States
Study dates
30 Sep 2021to 16 Jun 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent and in this protocol
  • Age >= 18 years old
  • Histologically/cytological confirmed adenoid cystic carcinoma (ACC) of any primary site
  • Evidence of NOTCH1 pathway activation as determined by NICD1 IHC nuclear staining in >= 70% of tumor cells
  • Patients must have surgically resectable disease, either with a curative intent or for local control in the setting of metastatic disease, in the opinion of the treating physician
  • Patients must be willing to undergo baseline biopsy to obtain tumor material
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  • Disease must be measurable by RECIST 1.1
  • Performance status Eastern Cooperative Oncology Group (ECOG) 0 or 1
  • Neutrophils < 1500/mm^3
  • Platelet count < 100,000/mm^3
  • Hemoglobin < 9 g/dL
  • Total bilirubin > 1.5 upper limit of normal (ULN) (except known Gilbert's syndrome)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 2.5 of upper limit of normality (ULN) OR > 5 ULN for patients with liver metastases
  • Creatinine clearance < 40 mL/min (Calculation of creatinine clearance [CrCl] will be based on acceptable institution standard)
  • Female patients with reproductive potential must practice two effective contraceptive measures for the duration of study drug therapy and for at least 90 days after completion of AL101 therapy. The two birth control methods can be either two barrier methods or a barrier method plus a hormonal method to prevent pregnancy. The following are considered adequate barrier methods of contraception: diaphragm, condom, copper intrauterine device, sponge, or spermicide. Appropriate hormonal contraceptives will include any registered and marketed contraceptive agent that contains an estrogen and/or a progestational agent (including oral, subcutaneous, intrauterine, or intramuscular agents)
  • Male patients who are sexually active with women with reproductive potential must agree to use contraception for the duration of treatment and for at least 90 days after completion of AL101 therapy

Who cannot join

  • Prior radiotherapy, chemotherapy, or biologic therapy is allowed in patients with loco-regional recurrent disease, if administered at least 4 weeks prior to study enrollment
  • Prior treatment with gamma-secretase inhibitor
  • History of previous malignancy other than malignancy treated with curative intent and with no evidence of active disease >= 2 years before the first dose of study drug and of low potential risk for recurrence. Patients with the following diagnoses represents an exception and may enroll:
  • Non-melanoma skin cancers with no current evidence of disease
  • Melanoma in situ with no current evidence of disease
  • Localized cancer of the prostate with prostate-specific antigen of < 0.1 ng/mL
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  • Treated or localized well-differentiated thyroid cancer
  • Treated cervical carcinoma in situ
  • Treated ductal/lobular carcinoma in situ of the breast
  • Current or recent (within 2 months of investigational product administration) gastrointestinal disease such as disorders that increase the risk of diarrhea (e.g.: inflammatory bowel disease). Non-chronic conditions (e.g., infectious diarrhea) that are completely resolved for at least 2 weeks prior to starting investigational product are not exclusionary
  • Evidence of clinically significant bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation)
  • Evidence of uncontrolled, active infection, requiring systemic anti-bacterial, anti-viral or anti-fungal therapy =< 7 days prior to administration of investigational product such as known active infection with hepatitis B and hepatitis C (HCV) at Screening
  • Symptomatic central nervous system (CNS) metastases. Patients with asymptomatic CNS metastases as well as those with previously treated CNS metastases are eligible for enrollment in the study if at least four weeks has elapsed since last whole brain radiation treatment or at least two weeks has elapsed since last focal radiation treatment and the patient is deemed clinically stable by the investigator
  • Unstable or severe uncontrolled medical condition (e.g., unstable cardiac or pulmonary function or uncontrolled diabetes) or any important medical illness or abnormal laboratory finding that would, in the investigator's judgment, increase the risk to the patient associated with his or her participation in the study
  • Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) >= 480 msec
  • Female subjects who are pregnant or breast-feeding
  • Hypersensitivity and/or history of allergy to the investigational product excipients

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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:

  1. 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.

Medical subject headings
Carcinoma, Adenoid Cystic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04973683
Study groupRoleWhat they receive
Treatment (AL101)ExperimentalPatients 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.
Receives: Drug: AL101; Procedure: Therapeutic Conventional Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse events

    Adverse events will be graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Frequency tables will summarize toxicity data for all patients. Logistic regression may be utilized to assess the effect of patient prognostic factors on the response and toxicity.

    Measured: Up to 2 years

  2. Changes in NICD1 levels

    Evaluated by immunohistochemistry in the post-treatment surgical specimen (at 6 to 8 weeks) as compared to baseline (pre-treatment) in patients treated with AL101

    Measured: Baseline and after surgery

Secondary outcomes (1)

  1. Overall response rate

    Evaluated per Response Evaluation Criteria in Solid Tumors. Logistic regression may be utilized to assess the effect of patient prognostic factors on the response and toxicity.

    Measured: At 6-8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2021
  2. Study start30 Sep 2021
  3. Primary completion16 Jun 2026
  4. Study completion16 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04973683
Sponsor's protocol ID
2021-0296
Other IDs
NCI-2021-05878, 2021-0296
Status last verified
Jun 2026
First submitted
18 Jun 2021
Last updated
24 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AL101 and Therapeutic Conventional Surgery in people with Adenoid Cystic Carcinoma and Metastatic Adenoid Cystic Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events (time frame: Up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04973683.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.

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