Baseline demographics and characteristics
| AMG 404 240 mg (n=3) | AMG 404 480 mg (n=144) | AMG 404 1050 mg (n=21) | All dose cohorts (n=168) | |
| Sex | ||||
| Male | 2 (66.7) | 77 (53.5) | 10 (47.6) | 89 (53.0) |
| Ethnicity | ||||
| Hispanic/Latino | 2 (66.7) | 9 (6.3) | 1 (4.8) | 12 (7.1) |
| Not Hispanic/Latino | 1 (33.3) | 130 (90.3) | 19 (90.5) | 150 (89.3) |
| Unknown | 0 | 5 (3.5) | 1 (4.8) | 6 (3.6) |
| Race | ||||
| Asian | 0 | 36 (25.0) | 4 (19.0) | 40 (23.8) |
| Black or African American | 1 (33.3) | 5 (3.5) | 1 (4.8) | 7 (4.2) |
| Multiple* | 0 | 0 | 1 (4.8) | 1 (0.6) |
| White | 2 (66.7) | 96 (66.7) | 14 (66.7) | 112 (66.7) |
| Other | 0 | 7 (4.9) | 1 (4.8) | 8 (4.8) |
| Age, median (range), years | 65 (47–66) | 62 (26–84) | 59 (38–79) | 62 (26–84) |
| Age group | ||||
| 18–65 years | 2 (66.7) | 90 (62.5) | 15 (71.4) | 107 (63.7) |
| ≥66 years | 1 (33.3) | 54 (37.5) | 6 (28.6) | 61 (36.3) |
| Primary tumour type | ||||
| Gastrointestinal | 1 (33.3) | 52 (36.1) | 6 (28.6) | 59 (35.1) |
| Thoracic and head and neck | 0 | 35 (24.3) | 2 (9.5) | 37 (22.0) |
| Gynaecological | 1 (33.3) | 20 (13.9) | 4 (19.0) | 25 (14.9) |
| Sarcoma | 0 | 23 (16.0) | 0 | 23 (13.7) |
| Other | 1 (33.3) | 8 (5.6) | 9 (42.9) | 18 (10.7) |
| Renal | 0 | 6 (4.2) | 0 | 6 (3.6) |
| ECOG performance status | ||||
| 0 | 0 (0.0) | 43 (29.9) | 4 (19.0) | 47 (28.0) |
| 1 | 3 (100.0) | 98 (68.1) | 17 (81.0) | 118 (70.2) |
| 2 | 0 | 3 (2.1) | 0 | 3 (1.8) |
| Prior anticancer therapy | 3 (100.0) | 121 (84.0) | 18 (85.7) | 142 (84.5) |
| Lines of prior anticancer therapy | ||||
| 1 | 1 (33.3) | 48 (33.3) | 4 (19.0) | 53 (31.5) |
| 2 | 0 | 30 (20.8) | 4 (19.0) | 34 (20.2) |
| 3 | 0 | 20 (13.9) | 5 (23.8) | 25 (14.9) |
| >3 | 2 (66.7) | 23 (16.0) | 5 (23.8) | 30 (17.9) |
| Number of lines of prior anticancer therapy, median (range) | 4 (1–7) | 2 (1–7) | 3 (1–5) | 2 (1–7) |
| Prior surgery | 2 (66.7) | 105 (72.9) | 18 (85.7) | 125 (74.4) |
Data are presented as number (%) of patients, unless indicated otherwise.
The safety analysis set comprised all patients who received ≥1 dose of AMG 404.
One patient in the AMG 404 240 mg cohort had intrapatient dose escalation to 480 mg after cycle 4.
*Included patients of more than one race.
ECOG, Eastern Cooperative Oncology Group.