Tumor responses according to the dose level evaluable population of 50 patients
| . | Part 1 . | Part 2 . | Total (N = 50), n (%) . | ||||
|---|---|---|---|---|---|---|---|
| Cohort 1 10 mg/m2 (n = 4), n (%) . | Cohort 2 15 mg/ m2 (n = 3), n (%) . | Cohort 3 20 mg/ m2 (n = 3), n (%) . | Cohort 4 25 mg/ m2 (n = 3), n (%) . | Cohort 5 30 mg/ m2 (n = 6), n (%) . | Expansion 30 mg/ m2 (n = 31), n (%) . | ||
| Overall response per lugano classification | |||||||
| CR | 3 (75.0) | 1 (33.3) | 2 (66.7) | 2 (66.7) | 5 (83.3) | 20 (64.5) | 33 (66.0) |
| PR | 1 (25.0) | 1 (33.3) | 1 (33.3) | 1 (33.3) | 0 | 6 (19.4) | 10 (20.0) |
| Stable disease | 0 | 1 (33.3) | 0 | 0 | 1 (16.7) | 0 | 2 (4.0) |
| Progressive disease | 0 | 0 | 0 | 0 | 0 | 4 (12.9) | 4 (8.0) |
| Not evaluable | 0 | 0 | 0 | 0 | 0 | 1 (3.2) | 1 (2.0) |
| Objective response rate | |||||||
| CR | 3 (75.0) | 1 (33.3) | 2 (66.7) | 2 (66.7) | 5 (83.3) | 20 (64.5) | 33 (66.0) |
| 95% CI (%) | 19.41, 99.37 | 0.84, 90.57 | 9.43, 99.16 | 9.43, 99.16 | 35.88, 99.58 | 45.37, 80.77 | 51.23, 78.79 |
| Overall response (CR + PR) | 4 (100.0) | 2 (66.7) | 3 (100.0) | 3 (100.0) | 5 (83.3) | 26 (83.9) | 43 (86.0) |
| 95% CI (%) | 39.76, 100.0 | 9.43, 99.16 | 29.24, 100.0 | 29.24, 100.0 | 35.88, 99.58 | 66.27, 94.55 | 73.26, 94.18 |
| . | Part 1 . | Part 2 . | Total (N = 50), n (%) . | ||||
|---|---|---|---|---|---|---|---|
| Cohort 1 10 mg/m2 (n = 4), n (%) . | Cohort 2 15 mg/ m2 (n = 3), n (%) . | Cohort 3 20 mg/ m2 (n = 3), n (%) . | Cohort 4 25 mg/ m2 (n = 3), n (%) . | Cohort 5 30 mg/ m2 (n = 6), n (%) . | Expansion 30 mg/ m2 (n = 31), n (%) . | ||
| Overall response per lugano classification | |||||||
| CR | 3 (75.0) | 1 (33.3) | 2 (66.7) | 2 (66.7) | 5 (83.3) | 20 (64.5) | 33 (66.0) |
| PR | 1 (25.0) | 1 (33.3) | 1 (33.3) | 1 (33.3) | 0 | 6 (19.4) | 10 (20.0) |
| Stable disease | 0 | 1 (33.3) | 0 | 0 | 1 (16.7) | 0 | 2 (4.0) |
| Progressive disease | 0 | 0 | 0 | 0 | 0 | 4 (12.9) | 4 (8.0) |
| Not evaluable | 0 | 0 | 0 | 0 | 0 | 1 (3.2) | 1 (2.0) |
| Objective response rate | |||||||
| CR | 3 (75.0) | 1 (33.3) | 2 (66.7) | 2 (66.7) | 5 (83.3) | 20 (64.5) | 33 (66.0) |
| 95% CI (%) | 19.41, 99.37 | 0.84, 90.57 | 9.43, 99.16 | 9.43, 99.16 | 35.88, 99.58 | 45.37, 80.77 | 51.23, 78.79 |
| Overall response (CR + PR) | 4 (100.0) | 2 (66.7) | 3 (100.0) | 3 (100.0) | 5 (83.3) | 26 (83.9) | 43 (86.0) |
| 95% CI (%) | 39.76, 100.0 | 9.43, 99.16 | 29.24, 100.0 | 29.24, 100.0 | 35.88, 99.58 | 66.27, 94.55 | 73.26, 94.18 |