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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.