Table 1. Demographics of Phase II patients (safety analysis set).
| Cohort 1 (NSCLC) | Cohort 2 (biliary tract cancer) | Cohort 3 (bladder cancer) | Totala | |
|---|---|---|---|---|
| N = 33 | N = 49 | N = 12 | N = 97 | |
| Age, years, median (range) | 61.0 (34–79) | 64.0 (35–76) | 65.0 (46–80) | 63.0 (34–80) |
| Gender, No. (%) | ||||
| Male | 26 (78.8) | 31 (63.3) | 11 (91.7) | 70 (72.2) |
| Female | 7 (21.2) | 18 (36.7) | 1 (8.3) | 27 (27.8) |
| Race, No. (%) | ||||
| White | 33 (100) | 44 (89.8) | 11 (91.7) | 90 (92.8) |
| Black | 0 | 1 (2.0) | 1 (8.3) | 3 (3.1) |
| Asian | 0 | 2 (4.1) | 0 | 2 (2.1) |
| Other | 0 | 2 (4.1) | 0 | 2 (2.1) |
| ECOG at baseline, No. (%) | ||||
| Grade 0 | 2 (6.1) | 9 (18.4) | 4 (33.3) | 16 (16.5) |
| Grade 1 | 31 (93.9) | 40 (81.6) | 8 (66.7) | 81 (83.5) |
| Number of patients with at least one prior chemotherapy | 3 (9.1) | 3 (6.1) | 3 (25.0) | 10 (10.3) |
| Number of patients with at least one prior radiation | 11 (33.3) | 3 (6.1) | 1 (8.3) | 15 (15.5) |
| Number of patients with at least one surgical procedure | 12 (36.4) | 31 (63.3) | 10 (83.3) | 56 (57.7) |
aOne patient in each cohort was diagnosed incorrectly, resulting in assignment to the incorrect cohort. These patients are not included in the cohort safety analysis summaries but are included in the total patient number since they received study treatments.