Table 3.
Pharmacokinetic parameters of dalutrafusp alfa in patients with advanced solid tumors (pharmacokinetic analysis set)
| Dalutrafusp alfa doses (mg/kg) | |||||||
| Pharmacokinetic parameter | 0.3 n=1 |
1 n=1 |
3 n=3 |
10 n=3 |
20 n=3 |
30 n=7 |
45 n=3 |
| Cmax, μg/mL, mean (%CV) | 1.3 | 6.0 | 53.1 (18.9) | 144 (0.4) | 703 (26.8) | 858 (24.0) | 1180 (11.0) |
| Tmax, h, median, (Q1, Q3) | 2.08 | 2.00 | 1.85 (1.83, 2.05) | 1.97 (1.83, 3.00) | 1.75 (1.07, 1.82) | 1.45 (1.07, 3.12) | 1.12 (1.03, 4.93) |
| Ctrough, μg/mL, mean (%CV) | NE* | NE* | 0.037† | 0.076 (37.2)‡ | 15.1 (30.5)‡ | 32.1 (51.1)§ | 45.5 (9.5) |
| AUCtau, μg∙h/mL, mean (%CV) | NE* | NE* | 1480 (51.4) | 5310 (11.2) | 33,500 (4.9) | 51,600 (31.6)¶ | 64,900 (15.1) |
*Ctrough at 0.3 mg/kg and 1 mg/kg were below the limit of quantitation and thus AUCtau cannot be estimated robustly.
†n=1.
‡n=2.
§n=5.
¶n=6.
AUCtau, area under the concentration versus time curve over the dosing interval; Cmax, maximum observed drug concentration; Ctrough, trough drug concentration; CV, coefficient of variation; h, hours; NE, not estimated; Q, quartile; Tmax, time to reach Cmax.