Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04871282 | A Study of AL102 in Patients With Progressing Desmoid Tumors | PHASE2 | ACTIVE NOT_RECRUITING | 198 | — | — | Sep 1, 2021 | Dec 1, 2026 | Jun 8, 2026 | 53 | United States, Australia +9 |
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...