Table 4.
Investigator-assessed best response with confirmation according to modified RECIST 1.1 criteria
| Dose-level 1 (n = 3) | Dose-level 2 (n = 25) | Dose-level 3 (n = 8) | Total (N =36) | |
|---|---|---|---|---|
| 10 mg/kg | 15 mg/kg | 20 mg/kg | ||
| Best response | ||||
| Partial response | 2 (67%) | 11 (44%) | 1 (13%) | 14 (39%) |
| Stable disease | ||||
| Discontinued | 1 (33) | 11 (44%) | 3 (38%) | 15 (42%) |
| Ongoing | 0 | 2 (8%) | 0 | 2 (6%) |
| Progressive disease | 0 | 0 | 0 | 0 |
| Not evaluable | 0 | 1 (4%) | 4 (50%) | 5 (14%) |
| Response ratea | 2 (67%) | 11 (44%) | 1 (13%) | 14 (39%) |
| [9.4–99.2] | [24.4–65.1] | [0.3–52.7] | [23.1–56.5] |
a
Defined as # of complete responses + partial responses/n*100%; [95% confidence interval]