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AL102 · 1 trial · 2 indications
Evaluation of the safety and tolerability of AL102 in subjects with progressing desmoid tumors as defined by as defined by the frequency and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
PFS as defined as the time from randomization until the date of assessment of progression as assessed by BICR based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death by any cause
| Arm | Type | Description |
|---|---|---|
| Part A Main Study 1.2 mg daily | EXPERIMENTAL | AL102 1.2 mg |
| Part A Main Study 2 mg Intermittent | EXPERIMENTAL | AL102 2 mg |
| Part A Main Study 4 mg Intermittent | EXPERIMENTAL | AL102 4 mg |
| Part B AL102 | EXPERIMENTAL | AL102, recommended dose regimen from Part A, 1.2 mg daily |
| Part B Placebo | PLACEBO_COMPARATOR | Placebo to match recommended dose regimen from Part A |
| Open Label Extension | EXPERIMENTAL | AL102, recommended dose regimen from Part A, 1.2 mg daily |
| Name | Type | Description |
|---|---|---|
| AL102 | DRUG | AL102 is an inhibitor of gamma secretase-mediated Notch signaling. |
| Placebo | OTHER | Placebo to match AL102 |
Inclusion Criteria Part A: 1. At least 18 years of age (inclusive) at the time of signing the informed consent form (ICF). 2. Histologically confirmed desmoid tumor (aggressive fibromatosis) by local pathologist (prior to informed consent). 3. Disease progression, assessed locally by the investigat...
AL102 is an investigational small molecule being developed for the treatment of desmoid tumors, a type of soft tissue tumor. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
AL102 targets gamma secretase, an enzyme involved in cellular signaling. By inhibiting this enzyme, AL102 is being studied for its potential to interfere with pathways that drive desmoid tumor growth.
AL102 is being developed by Immunome, Inc., a biopharmaceutical company. The company is listed on the stock exchange under the ticker symbol IMNM.
AL102 is currently in Phase 2 clinical development. It is being evaluated in a randomized, double-blind, placebo-controlled trial for patients with progressing desmoid tumors. The drug is investigational and has not yet received regulatory approval.
AL102 is being studied in a Phase 2 clinical trial with the identifier NCT04871282. This trial is titled 'A Study of AL102 in Patients With Progressing Desmoid Tumors' and is active but not recruiting. The study has an enrollment of 198 participants and is being conducted across multiple countries.
AL102 is a distinct investigational drug developed by Immunome, Inc. It is not known to be the same as any other marketed medication. Its unique mechanism of action targets gamma secretase, setting it apart from other therapies.