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Table 4 Pharmacokinetic profile of huKS-IL2: serum pharmacokinetic parameters obtained on day 2 of cycle 1

From: A phase 1b study of humanized KS-interleukin-2 (huKS-IL2) immunocytokine with cyclophosphamide in patients with EpCAM-positive advanced solid tumors

Parameter huKS-IL2 dosing cohort, mg/m2
0.5 1.0 2.0 3.0 4.0
(n = 3) (n = 4) (n = 6) (n = 6) (n = 7)
Cmax, ng/mL      
 Mean (%CV) 132.6 (8.9) 316.4 (12.1) 567.6 (52.6) 1252.9 (24.8) 1323.9 (26.9)
 Min-Max 119.1–141.0 268.6–350.0 295.4–1052.0 888.1–1712.0 897.3–1687.9
AUC0-24h, ng/mL•h      
 Mean (%CV) 724.8 (16.5) 2989.7 (59.4) 4850.9 (106.1) 13329.1 (59.7) 12332.5 (28.7)
 Min-Max 593.0–826.8 1344.6–5374.7 1184.4–14596.4 6686.3–28917.9 7236.1–16825.5
AUC0-∞, ng/mL•h      
 Mean (%CV) 823.4 (22.4) 3849.4 (84.9) 6440.9 (128.7) 19769.3 (112.1) 13083.9 (30.0)
 Min-Max 627.8–993.9 1406.5–1921.7 1179.8–22682.1 6464.9–64645.7 7418.1–18043.6
t1/2, h      
 Mean (%CV) 2.7 (20.1) 6.5 (92.4) 4.4 (115.9) 8.5 (100.1) 5.1 (16.4)
 Min-Max 2.1–3.2 2.0–13.3 0.9–14.4 3.2–25.6 4.0–6.0
CL, L/h      
 Mean (%CV) 1.24 (40.2) 0.84 (75.7) 1.81 (78.4) 0.49 (59.7) 0.66 (41.1)
 Min-Max 0.83–1.79 0.26–1.72 0.20–3.27 0.08–0.97 0.32–1.09
  1. Data presented are the arithmetic mean (% coefficient of variation) and minimum–maximum values; AUC, area under the concentration–time curve; AUC 0-24h , AUC from time zero to 24 hours after the start of infusion; AUC 0-∞ , AUC from time zero to infinity; CL, total body clearance; C max , maximum concentration; CV, coefficient of variation; t 1/2 , apparent terminal half-life.