Table 1.
Dose escalation scheme
| Vadastuximab talirine dose cohorts on day 1 of 3-wk cycles, µg/kg | |
|---|---|
| Planned | Actual |
| 5 | 5 |
| 10 | 10 |
| 20 | 20 |
| 40 | 30 |
| 80 | 40 |
| 120 | 50 |
| 180 | 60 |
| 250 | — |
Patients were allowed a maximum of 2 cycles at each dose level of to achieve a response. Patients who achieved a CR or CRi during the first 2 cycles were eligible for extension treatment every 3 weeks at a dose of 5 or 10 µg/kg. Although formal MTD was never exceeded at the doses tested, planned dose levels between 80 μg/kg and 250 μg/kg were never tested.