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Also known as varegacestat
AL102 · 6 trials · 5 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
AUC0-t varegacestat and metabolite
AUC0-t for varegacestat administered with and without itraconazole.
| 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 |
| Reference Formulation, then Test Formulation | EXPERIMENTAL | - |
| Test Formulation, then Reference Formulation | EXPERIMENTAL | - |
| Treatment Arm | EXPERIMENTAL | Single oral dose of varegacestat administered on study day 1 |
| Drug: varegacestat | EXPERIMENTAL | Single oral dose of varegacestat administered on study Day 1 |
| Varegacestat | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Moxifloxacin | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| AL102 | DRUG | AL102 is an inhibitor of gamma secretase-mediated Notch signaling. |
| Placebo | OTHER | Placebo to match AL102 |
| Varegacestat Reference Formulation | DRUG | Oral administration |
| Varegacestat Test Formulation | DRUG | Oral administration |
| varegacestat | DRUG | experimental intervention |
| Moxifloxacin 400 mg | DRUG | Single oral dose of moxifloxacin |
| Itraconazole (200 mg) | DRUG | Intervention to evaluate DDI with experimental intervention |
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, also called desmoid tumors, a rare type of soft tissue tumor. It is being studied in patients with progressing desmoid tumors, including adolescents and adults age 12 years and older.
AL102 is a small molecule gamma secretase inhibitor. Gamma secretase is an enzyme, and inhibiting it is the mechanism by which AL102 is designed to act against desmoid tumors. This targeted enzyme approach distinguishes AL102 from conventional cytotoxic chemotherapy.
AL102 is being developed by Immunome, Inc., which trades on the Nasdaq under the ticker IMNM. Immunome is the sponsor of the clinical program evaluating AL102 in desmoid tumors.
AL102 is in late-stage development, with a New Drug Application or Biologics License Application, NDA/BLA, stage reached. Its clinical program includes a Phase 2 trial in desmoid tumors. AL102 is investigational and has not been established as approved for commercial use.
AL102 is being evaluated in the Phase 2 trial NCT04871282, titled A Study of AL102 in Patients With Progressing Desmoid Tumors. The trial is active but not recruiting, has enrolled 198 patients, and is randomized, double-blind, and placebo-controlled across sites in the United States, Europe, Australia, Israel, and South Korea.