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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05145816 | Phase 1/2a Study of Belantamab Mafodotin in Relapsed or Refractory AL Amyloidosis | PHASE1 | RECRUITING | 37 | — | — | Feb 15, 2024 | Sep 1, 2027 | May 7, 2026 | 3 | United States |
Safety/Tolerability is measured by the number of participants treated with different dose level of belantamab mafodotin who experience dose limiting toxicity adverse events (AE) \>= Grade 3, as defined by Common Terminology Criteria for Adverse Events by CTCAE v5.0 for Part 1.
Safety/Tolerability at the recommended Phase II dose of Belantamab Mafodotin is measured by the number of subjects who experience dose limiting toxicities (\>= Grade 3, as defined by Common Terminology Criteria for Adverse Events by CTCAE v5.0) and cardiac and ocular AEs.
| Arm | Type | Description |
|---|---|---|
| Cohort (DL 0) for Part 1 | EXPERIMENTAL | Cohort (DL 0) for Starting Dose : 1.9 mg/kg Belantamab mafodotin intravenously every 8 weeks |
| Cohort (DL +1) for Part 1 | EXPERIMENTAL | Cohort (DL +1) for Dose Escalation: 2.5 mg/kg Belantamab mafodotin intravenously every 8 weeks |
| Cohort (DL -1) for Part 1 | EXPERIMENTAL | Cohort (DL -1) for Dose De-escalation : 1.9 mg/kg Belantamab mafodotin intravenously every 12 weeks |
| Cohort (DL -2) for Part 1 | EXPERIMENTAL | Cohort (DL -2) for Dose De-escalation: 1.4 mg/kg Belantamab mafodotin intravenously every 12 weeks |
| Cohort Dose Expansion for Part 2 | EXPERIMENTAL | Cohort Dose expansion for Part 2: Belantamab mafodotin Dose from1.0 mg/kg to 2.5mg/kg every 8 or 12 weeks as determined by Part 1 recommended dosage calculations. |
| Cohort (DL -3) for Part 1 | EXPERIMENTAL | Cohort (DL -3) for Dose De-escalation: 1.0 mg/kg Belantamab mafodotin intravenously every 12 weeks |
| Name | Type | Description |
|---|---|---|
| Belantamab mafodotin 2.5 mg/kg (8 weeks) | DRUG | 2.5 mg/kg IV Belantamab mafodotin IV every 8 weeks for Part 1 |
| Belantamab mafodotin 1.9 mg/kg (8 weeks) | DRUG | 1.9 mg/kg IV Belantamab mafodotin IV every 8weeks for Part 1 |
| Belantamab mafodotin 1.4 mg/kg (12 weeks) | DRUG | 1.4 mg/kg Belantamab mafodotin IV every 12 weeks for Part 1 |
| Belantamab mafodotin 1.9 mg/kg (12 weeks) | DRUG | 1.9 mg/kg Belantamab mafodotin IV every 12 weeks for Part 1 |
| Belantamab mafodotin every 8 weeks or 12 weeks as determined by Part 1 recommended dosages | DRUG | Belantamab mafodotin Dose 1.0 mg/kg, 1.4 mg/kg, 1.9mg/kg or 2.5mg/kg every 8 weeks or 12 weeks as determined by Part 1 recommended dosages. |
| Belantamab mafodotin 1.0 mg/kg (12 weeks) | DRUG | 1.0 mg/kg Belantamab mafodotin IV every 12 weeks for Part 1 |
Inclusion Criteria: 1. Participants medically diagnosed with relapsed or refractory Amyloid Light Chain Amyloidosis (AL amyloidosis) with one or more line of treatment as below: 1. Must have received a proteosome inhibitor, alkylator and anti-cluster of differentiation 38 (CD38) antibody (e.g.,...