Patient demographics, clinical characteristics, and disposition
| Characteristic . | Monotherapy . | Combination . | |||||
|---|---|---|---|---|---|---|---|
| 1.25 mg/kg (n = 1) . | 3.75 mg/kg (n = 1) . | 7.5 mg/kg (n = 2) . | Total (N = 4) . | 3.75 mg/kg (n = 10) . | 7.5 mg/kg (n = 13) . | Total (N = 23) . | |
| Age, years, median (range) | 82 (82-82) | 71 (71-71) | 75 (71-78) | 75 (71-78) | 72 (60-79) | 71 (35-82) | 71 (35-82) |
| Sex, n (%) | |||||||
| Female | 1 (100) | 1 (100) | 1 (50) | 3 (75) | 2 (20) | 7 (54) | 9 (39) |
| Male | 0 | 0 | 1 (50) | 1 (25) | 8 (80) | 6 (46) | 14 (61) |
| Time from diagnosis, years, median (range) | 1.4 (1.4-1.4) | 0.3 (0.3-0.3) | 1.1 (0.8-1.3) | 1.1 (0.3-1.4) | 1.1 (0.2-2.7) | 0.8 (0.1-4.6) | 1 (0.1-4.6) |
| Previous therapies, n (%) | |||||||
| 0 | 0 | 0 | 0 | 0 | 1 (10) | 1 (8) | 2 (9) |
| 1 | 0 | 0 | 1 (50) | 1 (25) | 4 (40) | 6 (46) | 10 (43) |
| 2 | 0 | 1 (100) | 0 | 1 (25) | 5 (50) | 2 (15) | 7 (30) |
| 3 | 0 | 0 | 1 (50) | 1 (25) | 0 | 0 | 0 |
| 4 | 1 (100) | 0 | 0 | 1 (25) | 0 | 0 | 0 |
| ≥5 | 0 | 0 | 0 | 0 | 0 | 4 (31) | 4 (17) |
| Study drug discontinuation, n | 1 | 1 | 2 | 4 | 9 | 12 | 21 |
| Primary reason, n (%) | |||||||
| Adverse event | 0 | 0 | 0 | 0 | 2 (22) | 2 (17) | 4 (19) |
| Withdrawal of consent | 0 | 0 | 0 | 0 | 1 (11) | 1 (8) | 2 (9) |
| Progressive disease | 1 (100) | 0 | 0 | 1 (25) | 5 (56) | 6 (50) | 11 (52) |
| Physician decision | 0 | 1 (100) | 1 (50) | 2 (50) | 0 | 1 (8) | 1 (5) |
| Other | 0 | 0 | 1 (50) | 1 (25) | 1 (11) | 2 (17) | 3 (14) |
| Characteristic . | Monotherapy . | Combination . | |||||
|---|---|---|---|---|---|---|---|
| 1.25 mg/kg (n = 1) . | 3.75 mg/kg (n = 1) . | 7.5 mg/kg (n = 2) . | Total (N = 4) . | 3.75 mg/kg (n = 10) . | 7.5 mg/kg (n = 13) . | Total (N = 23) . | |
| Age, years, median (range) | 82 (82-82) | 71 (71-71) | 75 (71-78) | 75 (71-78) | 72 (60-79) | 71 (35-82) | 71 (35-82) |
| Sex, n (%) | |||||||
| Female | 1 (100) | 1 (100) | 1 (50) | 3 (75) | 2 (20) | 7 (54) | 9 (39) |
| Male | 0 | 0 | 1 (50) | 1 (25) | 8 (80) | 6 (46) | 14 (61) |
| Time from diagnosis, years, median (range) | 1.4 (1.4-1.4) | 0.3 (0.3-0.3) | 1.1 (0.8-1.3) | 1.1 (0.3-1.4) | 1.1 (0.2-2.7) | 0.8 (0.1-4.6) | 1 (0.1-4.6) |
| Previous therapies, n (%) | |||||||
| 0 | 0 | 0 | 0 | 0 | 1 (10) | 1 (8) | 2 (9) |
| 1 | 0 | 0 | 1 (50) | 1 (25) | 4 (40) | 6 (46) | 10 (43) |
| 2 | 0 | 1 (100) | 0 | 1 (25) | 5 (50) | 2 (15) | 7 (30) |
| 3 | 0 | 0 | 1 (50) | 1 (25) | 0 | 0 | 0 |
| 4 | 1 (100) | 0 | 0 | 1 (25) | 0 | 0 | 0 |
| ≥5 | 0 | 0 | 0 | 0 | 0 | 4 (31) | 4 (17) |
| Study drug discontinuation, n | 1 | 1 | 2 | 4 | 9 | 12 | 21 |
| Primary reason, n (%) | |||||||
| Adverse event | 0 | 0 | 0 | 0 | 2 (22) | 2 (17) | 4 (19) |
| Withdrawal of consent | 0 | 0 | 0 | 0 | 1 (11) | 1 (8) | 2 (9) |
| Progressive disease | 1 (100) | 0 | 0 | 1 (25) | 5 (56) | 6 (50) | 11 (52) |
| Physician decision | 0 | 1 (100) | 1 (50) | 2 (50) | 0 | 1 (8) | 1 (5) |
| Other | 0 | 0 | 1 (50) | 1 (25) | 1 (11) | 2 (17) | 3 (14) |