Trials / Active Not Recruiting
Active Not RecruitingNCT04871282
A Study of AL102 in Patients With Progressing Desmoid Tumors
RINGSIDE: A Phase 2/3, Randomized, Multicenter Study to Evaluate AL102 in Patients With Progressing Desmoid Tumors
- Status
- Active Not Recruiting
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 198 (actual)
- Sponsor
- Immunome, Inc. · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
The current study is designed to evaluate the efficacy and safety of AL102 in patients with progressive desmoid tumors.
Detailed description
This is a Phase 2/3, randomized study in subjects with progressive desmoid tumors consisting of 2 parts. Phase2/Part A is an open-label, dose regimen finding study; Phase3/Part B is a double blind, placebo-controlled study and Open Label Extension utilizing the dose regimen selected in Phase2/Part A.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AL102 | AL102 is an inhibitor of gamma secretase-mediated Notch signaling. |
| OTHER | Placebo | Placebo to match AL102 |
Timeline
- Start date
- 2021-03-30
- Primary completion
- 2025-12-03
- Completion
- 2026-10-01
- First posted
- 2021-05-04
- Last updated
- 2026-02-05
Locations
53 sites across 11 countries: United States, Australia, Belgium, Germany, Israel, Italy, Netherlands, Poland, South Korea, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04871282. Inclusion in this directory is not an endorsement.