Summary statistics of pharmacokinetic parameters of enoblituzumab after 2-hour intravenous infusion doses of 3–15 mg/kg weekly
| Parameter | Unit | Statistic | Weekly enoblituzumab dose | ||
| 3 mg/kg | 10 mg/kg | 15 mg/kg | |||
| First dose, C1/D1 | |||||
| Cmax | µg/mL | GM (%CV) (n) | 84 (34) (5) | 238 (14) (2) | 420 (40) (99) |
| tmax | hour | Median (min–max) (n) | 3 (2–5) (5) | 2.5 (2–3) (2) | 3 (2–48) (99) |
| AUCτ | µg·hour/mL | GM (%CV) (n) | 6254 (35) (4) | 21 918 (15) (2) | 36 889 (36) (90) |
| AUC0–inf | µg·hour/mL | GM (%CV) (n) | 10 321 (46) (4) | 36 941 (10) (2) | 64 111 (39) (88) |
| CL | mL/hour/kg | Mean (SD) (n) | 0.314 (0.156) (4) | 0.271 (0.028) (2) | 0.250 (0.087) (88) |
| Vss | mL/kg | Mean (SD) (n) | 51.9 (14.1) (4) | 49.7 (8.8) (2) | 46.9 (15.2) (88) |
| t1/2 | hour | Mean (SD) (n) | 128.2 (21.2) (4) | 130.7 (9.1) (2) | 141.7 (45.6) (88) |
| Multiple dose, C2/D1 | |||||
| Cmax | µg/mL | GM (%CV) (n) | 167 (28) (4) | — | 797 (26) (62) |
| tmax | hour | Median (min–max) (n) | 3 (2–8) (4) | — | 3 (2–24) (62) |
| AUCτ | µg·hour/mL | GM (%CV) (n) | 19 981 (40) (4) | — | 93 590 (31) (51) |
| CL | mL/hour/kg | Mean (SD) (n) | 0.160 (0.072) (4) | — | 0.168 (0.054) (51) |
| Vss | mL/kg | Mean (SD) (n) | 59.1 (11.9) (4) | — | 62.1 (21.9) (46) |
| t1/2 | hour | Mean (SD) (n) | 283.7 (95.1) (4) | — | 275.6 (124.9) (46) |
| AI AUCτ | GM (%CV) (n) | 3.20 (9) (4) | — | 2.48 (48) (48) | |
AI, accumulation index; AUC0–inf, area under the serum concentration–time curve from time zero extrapolated to infinity; AUCτ, area under the concentration–time curve over the dosing interval; C, cycle; CL, clearance; Cmax, maximum observed serum concentration; CV, coefficient of variation; D, dose; GM, geometric mean; t1/2, half-life; tmax, time of maximum concentration; Vss, volume of distribution at steady state.