Table 1.
Demographics and clinical characteristics
| Dose-escalation and expansion part (N=50) | Clinical-expansion part | All patients | |
|---|---|---|---|
| (N=121) | (N=171) | ||
| Age, years | 55 (48–62) | 57 (50–65) | 56 (49–64) |
| Sex | |||
| Male | 30 (60%) | 98 (81%) | 128 (75%) |
| Female | 20 (40%) | 23 (19%) | 43 (25%) |
| ECOG performance status | |||
| 0 | 12 (24%) | 23 (19%) | 35 (20%) |
| 1 | 38 (76%) | 98 (81%) | 136 (80%) |
| No. of organs of metastases | |||
| 0 | 1 (2%) | 6 (5%) | 7 (4%) |
| 1 | 13 (26%) | 38 (31%) | 51 (30%) |
| 2 | 13 (26%) | 35 (29%) | 48 (28%) |
| 3 | 10 (20%) | 21 (17%) | 31 (18%) |
| 4 or more | 13 (26%) | 21 (17%) | 34 (20%) |
| Lines of prior anti-cancer therapies | |||
| 0 | 0 | 3 (3%) | 3 (2%) |
| 1 | 14 (28%) | 78 (64%) | 92 (76%) |
| 2 | 21 (42%) | 40 (33%) | 61 (50%) |
| 3 or more | 15 (30%) | 0 | 15 (9%) |
| Prior therapy | |||
| Chemotherapy | 46 (92%) | 95 (79%) | 141 (82%) |
| Targeted therapy | 25 (50%) | 42 (35%) | 67 (39%) |
| Immunotherapy | 5 (10%) | 1 (<1%) | 6 (4%) |
| Others | 5 (10%) | 5 (4%) | 10 (6%) |
ECOG Eastern Cooperative Oncology Group. Data are median (IQR) or n (%)