Table 3.
Summary of PK parameters for TQB2450 (n = 39).
| Dose | Number of patients enrolled | Mean ± SD | ||||||
|---|---|---|---|---|---|---|---|---|
| T1/2 (h) | Tmax (h) | Cmax (µg/mL) | Vd (L) | CL (L/h) | AUC0–t (h*µg/mL) | AUC0–∞ (h*µg/mL) | ||
| Dose-escalation (mg/kg) | ||||||||
| 1 | 1 | 85.19 | 3.02 | 19.46 | 4.22 | 0.034 | 1778.21 | 1904.56 |
| 3 | 6 | 281.35 ± 174.63 | 3.03 ± 3.12 | 65.38 ± 22.76 | 6.02 ± 1.71 | 0.020 ± 0.009 | 10,860.72 ± 4614.14 | 16,234.62 ± 9575.04 |
| 10 | 6 | 321.34 ± 98.73 | 1.31 ± 0.81 | 215.57 ± 23.32 | 7.01 ± 2.10 | 0.016 ± 0.004 | 42,422.23 ± 7260.76 | 63,977.46 ± 19,345.41 |
| 20 | 3 | 344.68 ± 150.03 | 2.98 ± 0.048 | 456.72 ± 75.66 | 6.56 ± 2.56 | 0.015 ± 0.006 | 97,045.46 ± 20,373.75 | 147,906.21 ± 57,347.98 |
| 30 | 6 | 340.22 ± 124.07 | 2.65 ± 2.37 | 566.82 ± 111.42 | 7.25 ± 2.86 | 0.015 ± 0.003 | 118,122.41 ± 18871.75 | 186,932.16 ± 29,842.29 |
| Dose-expansion (1200 mg) | 17 | 278.67 ± 80.43 | 3.16 ± 2.88 | 418.99 ± 142.56 | 6.06 ± 2.05 | 0.015 ± 0.004 | 82,326.48 ± 22,620.42 | 118,143.84 ± 37,254.55 |
AUC0–t, area under the plasma concentration–time curve from time 0 to the time of the last quantifiable concentration; AUC0–∞, area under the plasma concentration–time curve from time 0 to infinity; CL, clearance; Cmax, maximum observed plasma concentration; PK, pharmacokinetics; SD, standard deviations; Tmax, median time to peak plasma concentration; Vd, volume of distribution.