AL102 for Desmoid Tumors
(RINGSIDE Trial)
Trial Summary
What is the purpose of this trial?
This trial is testing a new drug called AL102 to see if it can help people with desmoid tumors that are getting worse. The study will find the best dose and then see if AL102 can stop or slow down the growth of these tumors.
Will I have to stop taking my current medications?
The trial requires that you stop any treatments for desmoid tumors, including chronic NSAIDs, at least 4 weeks before starting the study medication. However, the protocol does not specify if you need to stop other medications, so it's best to discuss this with the study team.
What data supports the effectiveness of the drug AL102 for desmoid tumors?
A case report showed that a similar drug, AL101, which also targets the Notch pathway, led to significant tumor shrinkage in patients with desmoid tumors. Additionally, in a phase 1 study, AL102, which is structurally similar to AL101, also showed tumor shrinkage in a patient with a desmoid tumor.12345
How does the drug AL102 differ from other treatments for desmoid tumors?
AL102 is unique because it is an orally administered gamma secretase inhibitor that targets the Notch pathway, which is involved in the development of desmoid tumors. This approach is novel as there are currently no approved systemic therapies for desmoid tumors, and AL102 offers a potential new treatment option for tumors that are not suitable for surgery or have recurred after other treatments.12356
Research Team
Mrinal Gounder, MD
Principal Investigator
MSKCC
Eligibility Criteria
This trial is for adults with desmoid tumors that are growing and causing pain not controlled by non-opioid medication. Participants must have at least one tumor measurable by MRI, be able to swallow capsules, and can be treatment-naïve or have tried other treatments without success.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Phase 2/Part A - Dose Regimen Finding
Open-label study to determine the optimal dose regimen of AL102 in patients with desmoid tumors
Phase 3/Part B - Double Blind
Double blind, placebo-controlled study to evaluate the efficacy and safety of AL102
Open Label Extension
Participants may opt into continuation of treatment with AL102 long-term
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- AL102
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
Immunome, Inc.
Lead Sponsor
Ayala Pharmaceuticals, Inc,
Lead Sponsor