Table 5.
Summary of PK parameters for mAb1024 after a single dose of Sym004 at week 1 and week 4 (weekly regimens) or week 5 (biweekly regimens)
| Geometric mean (GCV%) | |||||||
|---|---|---|---|---|---|---|---|
| AUC0‐inf (μg.h/mL) | AUC0‐inf/dose (μg.h/mL/mg) | C max (μg/mL) | t max (h)a | t 1/2 (h) | CL (L/h) | V z (L) | |
| Wk 1 | |||||||
| 6 mg/kg weekly (n = 3) | 5217.9 (26.6) | 31.86 (21.9) | 54.66 (15.6) | 2.05 (2.0, 2.1) | 74.08 (8.8) | 0.031 (21.9) | 3.35 (16.7) |
| 9/6 mg/kg weekly (n = 6) | 9182.6 (38.8) | 36.20 (37.4) | 89.44 (26.2) | 7.20 (3.2, 11) | 91.30 (21.7) | 0.028 (37.4) | 3.64 (17.6) |
| 12 mg/kg weekly, Part A (n = 6) | 15 075 (34.6) | 43.41 (23.1) | 116.2 (31.2) | 6.66 (3.1,11) | 100.1 (24.3) | 0.023 (23.1) | 3.32 (3.4) |
| 18 mg/kg biweekly (n = 6) | 27 554 (30.7) | 46.77 (30.9) | 187.0 (23.9) | 7.15 (3.2, 7.6) | 134.5 (27.8) | 0.021 (30.9) | 4.15 (29.1) |
| 12 mg/kg weekly, Part B (n = 6) | 14 781 (17.4) | 47.48 (17.5) | 146.9b (56.3) | 7.13b (3.2, 11) | 100.6 (34.8) | 0.021 (17.6) | 3.06 (47.0) |
| Wk 4 or 5 | |||||||
| 6 mg/kg weekly (n = 3) | ND | ND | 89.26 (10.2) | 2.07 (2.0, 2.1) | ND | ND | ND |
| 9/6 mg/kg weekly (n = 4) | 15 631 (51.4) | 94.91 (44.7) | 91.70c (33.4) | 6.13c (2.0, 18) | 117.8 (27.5) | 0.017 (30.6) | 2.85 (20.6) |
| 12 mg/kg weekly, Part A (n = 6) | 41 581 (71.2) | 118.1 (57.5) | 221.3 (21.1) | 5.18 (3.0, 7.3) | 155.9 (37.4) | 0.016 (32.9) | 3.71 (21.7) |
| 18 mg/kg biweekly (n = 5) | 43 308 (37.8) | 74.28 (36.3) | 224.0c (24.7) | 5.28c (3.1, 11) | 163.6 (36.3) | 0.018 (25.6) | 4.20 (27.7) |
| 12 mg/kg weekly, Part B (n = 4) | 41 351 (42.0) | 136.9 (46.8) | 231.9c (32.8) | 7.10c (3.1, 11) | 163.8 (27.5) | 0.014 (28.2) | 3.40 (24.9) |
AUC0‐inf, area under the curve from start of first infusion extrapolated to infinity; C max, maximum concentration; t max, time to C max; t 1/2, half‐life; CL, clearance; V z, apparent volume of distribution during the terminal phase; GCV%, geometric coefficient of variation; ND, not determined.
a
Median and range are reported.
b
n = 7.
c
n = 6.