Table 4.
Antidrug antibody.
| Measure | Dose-escalation | Dose-expansion | All (n = 39) | ||||
|---|---|---|---|---|---|---|---|
| 1 mg/kg (n = 1) | 3 mg/kg (n = 6) | 10 mg/kg (n = 6) | 20 mg/kg (n = 3) | 30 mg/kg (n = 6) | 1200 mg (n = 17) | ||
| Baseline test results (n, %) | |||||||
| Positive | 0 | 0 | 0 | 0 | 0 | 1 (5.88) | 1 (2.56) |
| Negative | 1 (100) | 6 (100) | 6 (100) | 3 (100) | 6 (100) | 16 (94.12) | 38 (97.44) |
| Test results during study (n, %) | |||||||
| Negative | 0 | 3 (50.00) | 3 (50.00) | 2 (66.67) | 5 (83.33) | 13 (76.47) | 26 (66.67) |
| Positive | 1 (100) | 3 (50.00) | 3 (50.00) | 1 (33.33) | 1 (16.67) | 4 (23.53) | 13 (33.33) |
| Positive at baseline | 0 | 0 | 0 | 0 | 0 | 1 (5.88) | 1 (2.56) |
| Last test was positive | 1 (100) | 3 (50.00) | 2 (33.33) | 0 | 1 (16.67) | 1 (5.88) | 8 (20.51) |
| Last test was negative | 0 | 0 | 1 (16.67) | 1 (33.33) | 0 | 3 (17.65) | 5 (12.82) |
| First time to positivity in participants negative at baseline (days, mean ± SD) | 15.00 | 12.70 ± 4.04 | 26.70 ± 14.57 | 15.00 | 15.00 | 30.80 ± 37.21 | 22.00 ± 21.19 |
| Duration of positivity in participants negative at baseline (days, mean ± SD) | 29.97 | 130.02 ± 92.11 | 15.00 ± 9.88 | 40.99 | 0 | 120.32 ± 14.01 | 85.20 ± 68.35 |
SD, standard deviations.