Monotherapy dose escalation and cohort expansion
| Dose . | 5 mg . | 10 mg . | 15 mg . | Expansion doses . | 45 mg . | |
|---|---|---|---|---|---|---|
| 20 mg . | 30 mg . | |||||
| n | 1 | 3 | 3 | 34 | 27 | 4 |
| Escalation rules | In case of a grade 2 or higher AE, the cohort was to be expanded to 3 patients | If 1 DLT was observed in the first 3 patients, 3 additional patients were to be enrolled in the cohort; if DLTs occurred in more than 1 of the first 3 patients or the total cohort of 6 patients, then the MTD was deemed to be exceeded | ||||
| Dose . | 5 mg . | 10 mg . | 15 mg . | Expansion doses . | 45 mg . | |
|---|---|---|---|---|---|---|
| 20 mg . | 30 mg . | |||||
| n | 1 | 3 | 3 | 34 | 27 | 4 |
| Escalation rules | In case of a grade 2 or higher AE, the cohort was to be expanded to 3 patients | If 1 DLT was observed in the first 3 patients, 3 additional patients were to be enrolled in the cohort; if DLTs occurred in more than 1 of the first 3 patients or the total cohort of 6 patients, then the MTD was deemed to be exceeded | ||||
DLT, dose-limiting toxicity; MTD, maximum tolerated dose.