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Table 5 Phamacokinetics results for imaging part (A) and therapeutic part (B)

From: A first-in-human study investigating biodistribution, safety and recommended dose of a new radiolabeled MAb targeting FZD10 in metastatic synovial sarcoma patients

Parameter

Cmax

Tmax

T1/2

AUC C0-336a

CL

Vdss

Units

ng/mL

Hours

Hours

ng*Hours/mL

mL/Hours

mL

A. Imaging Part (n = 17)

 Mean

483.8

1.3

265.7

154,724

38.6

3311.9

 S.D.

193.3

2.2

316.9

378,371

15.9

998.3

 %CV

39.9

167.9

119.3

244.55

41.3

30.3

B. Therapeutic part (n = 8)

ARM A (370 MBq, n = 3)

 Mean

365.4

0.00

87.4

42,106.7

255.4

4950.0

 S.D.

240.3

 

66.6

38,489.5

391.9

4811.6

 %CV

65.7

 

76.2

91.41

153.5

97.2

ARM B (1100 MBq, n = 4b)

 Mean

362.0

1.0

61.8

38,275.0

63.0

1787.7

 S.D.

112.2

1.1

29.0

15,024.7

46.1

1040.5

 %CV

31.0

115.5

46.9

39.25

73.1

58.2

  1. NB: PK data were not analyzed for patients ID 01–0018, 01–019, 01–020 due to premature study and OTS-France closure
  2. aor AUC extrapolated and BLQ concentration set to zero. bdata following the 2nd injection of patient 01–003 are included