CWP291 dose cohorts evaluated in this study
| Cohort . | Number of patients . | CWP291 dose, mg/m2 . | Increment, % . |
|---|---|---|---|
| Dose escalation | |||
| 1 | 4 | 4 | — |
| 2 | 3 | 8 | 100 |
| 3 | 3 | 13 | 67 |
| 4 | 3 | 19 | 50 |
| 5 | 3 | 26 | 40 |
| 6 | 5 | 33 | 30 |
| 7 | 3 | 42 | 30 |
| 8 | 6 | 54 | 30 |
| 9 | 3 | 70 | 30 |
| 10 | 4 | 91 | 30 |
| 11 | 4 | 118 | 30 |
| 12 | 6 | 153 | 30 |
| 13 | 6 | 198 | 30 |
| 14 | 6 | 257 | 30 |
| 15 | 4 | 334 | 30 |
| Dose expansion | |||
| 14.1 | 6 | 257 | — |
| Cohort . | Number of patients . | CWP291 dose, mg/m2 . | Increment, % . |
|---|---|---|---|
| Dose escalation | |||
| 1 | 4 | 4 | — |
| 2 | 3 | 8 | 100 |
| 3 | 3 | 13 | 67 |
| 4 | 3 | 19 | 50 |
| 5 | 3 | 26 | 40 |
| 6 | 5 | 33 | 30 |
| 7 | 3 | 42 | 30 |
| 8 | 6 | 54 | 30 |
| 9 | 3 | 70 | 30 |
| 10 | 4 | 91 | 30 |
| 11 | 4 | 118 | 30 |
| 12 | 6 | 153 | 30 |
| 13 | 6 | 198 | 30 |
| 14 | 6 | 257 | 30 |
| 15 | 4 | 334 | 30 |
| Dose expansion | |||
| 14.1 | 6 | 257 | — |
The study drug was infused over a 5-minute duration for cohorts 1 to 13 and over at least a 30-minute duration for cohorts 14 and 15. For dose-expansion cohort 14.1, the study drug was infused over a 2-hour duration. Patients in cohort 13 onward received prophylaxis with antihistamines and hydrocortisone from day 1, per institutional practice, to avoid potentially severe allergic reactions.