Active not recruitingPHASE2, PHASE3INTERVENTIONAL

A Study of AL102 in Patients With Progressing Desmoid Tumors

This research is investigating a new treatment called AL102 for desmoid tumours that are getting larger. Desmoid tumours are rare, non-cancerous growths that can cause pain and problems. The study, which includes two main phases, will first help doctors find the best dose of AL102. Afterwards, it will compare AL102 to a placebo (a treatment with no active drug) to understand how effective and safe it is. This is important to help find better ways to manage these challenging tumours and improve people's quality of life. The study aims to provide clearer answers about AL102 as a potential new option.

At a glance

Status

Active not recruiting

Phase

PHASE2, PHASE3

Sponsor

Immunome, Inc.

Enrolment target

198

Start

30 Mar 2021

Estimated completion

01 Oct 2026

Desmoid Desmoid Tumor

What is this study about?

This study is focused on people who have desmoid tumours that are growing or causing problems. Desmoid tumours are unusual growths that, while not cancerous, can be difficult to manage because they can grow quite large and cause pain or affect how your body works. The new medication being tested in this study is called AL102. Researchers want to find out two main things: whether it works to stop or slow the growth of these tumours, and if it's safe for people to take.

The study is split into two main parts. The first part is like a fact-finding mission where doctors will try out different doses of AL102 to figure out which one works best and is easiest to tolerate. Once they've found the best dose, the study moves into a second, larger part. In this part, some participants will receive AL102, and others will receive a 'placebo' – this is an inactive substance that looks just like the real medicine but contains no drug. This helps researchers understand if any improvements are genuinely due to AL102 or if they might happen anyway.

The overall goal of this research is to see if AL102 could become a valuable new treatment option for people living with desmoid tumours. By understanding its effects, doctors can make more informed decisions about how to help their patients, potentially offering a new way to manage these often challenging growths and improve patients' daily lives.

Key takeaways

This study is testing a new medication, AL102, for growing desmoid tumours.
It aims to find the best dose and compare AL102 to a placebo to check its effectiveness and safety.
Participants must be at least 18 with a confirmed, progressing desmoid tumour.
Regular hospital visits, scans, and blood tests will be part of the participation.
There's a potential benefit of receiving a new treatment, but also possible side effects or receiving a placebo.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old and have a desmoid tumour that has been confirmed by a doctor. Your tumour must also be getting bigger, either by growing at least 10% in size over 18 months, or by causing pain that isn't controlled by regular painkillers.

It's important that you haven't been diagnosed with any other cancer in the last two years (with some specific exceptions), and you shouldn't have certain gut problems that could affect how the medicine is absorbed, or make you more prone to diarrhoea. You also shouldn't have any serious uncontrolled infections or severe heart problems.

Basically, the study is looking for adults with growing desmoid tumours who are generally in reasonable health, can swallow capsules, and do not have certain other serious medical conditions that might make the treatment unsafe or difficult to assess.

Quick self-check

Are you at least 18 years old?
Has a doctor confirmed you have a desmoid tumour that is currently growing?
Do you generally feel well and not have other serious medical conditions like heart problems or recent cancer?
Can you swallow capsules whole?
Are you able to attend regular hospital appointments for check-ups and scans?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you'll first have some tests to make sure you're suitable. The study has two main parts. In the first part, you'll receive AL102, and doctors will carefully adjust the dose to find the best one. In the second part, you might receive AL102 or a 'dummy' tablet (placebo) – you won't know which one you're getting. You'll have regular hospital visits for check-ups, scans (like MRI to measure your tumour), and blood tests. You'll need to be able to swallow capsules whole, as the medication is taken by mouth. The total duration of your participation will depend on the study's progress and your individual situation, including follow-up visits after treatment ends.

Potential risks and benefits

Participating in this study might offer the potential benefit of receiving a new treatment that could help manage your desmoid tumour, potentially slowing its growth or reducing pain. However, there's also a chance you might receive a placebo, meaning you wouldn’t get the active drug during part of the study. All medications carry potential risks and side effects, and AL102 might have some that we don't fully know yet. You will be closely monitored for any side effects. It's important to remember that you are free to stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (53)

Mayo Clinic
Pheonix, United States
City of Hope
Duarte, United States
Sarcoma Oncology Research Center
Santa Monica, United States
University of California at Los Angeles Hematology/Oncology
Santa Monica, United States
Stanford University Medical Center
Stanford, United States
Mayo Clinic
Jacksonville, United States
NorthShore University Health System
Evanston, United States
Massachusetts General Hospital
Boston, United States
University of Michigan
Ann Arbor, United States
Jefferson City Medical Group
Jefferson City, United States
Washington University
St Louis, United States
Columbia University Irving Medical Center
New York, United States

+41 more sites — see the official record for the full list.

Common questions

What is a desmoid tumour?

A desmoid tumour is a rare type of growth that is not cancerous but can be aggressive, growing into nearby tissues and causing problems like pain.

What is a placebo?

A placebo is a 'dummy' treatment that looks like the real medicine but contains no active drug. It helps researchers fairly compare the new drug's effects.

Will I know if I'm getting the active drug or the placebo?

In the second part of the study, neither you nor your doctors will know if you're receiving the active drug (AL102) or the placebo. This is called 'double-blind'.

How is AL102 taken?

AL102 is taken by mouth as capsules. You must be able to swallow them whole.

Can I leave the study if I change my mind?

Yes, you can decide to stop participating in the study at any time, for any reason, without affecting your regular medical care.