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Table 3 Primary pharmacokinetic parameters for LJM716 3–40 mg/kg QW (Cycle 1 Day 1)

From: A phase I open-label dose-escalation study of the anti-HER3 monoclonal antibody LJM716 in patients with advanced squamous cell carcinoma of the esophagus or head and neck and HER2-overexpressing breast or gastric cancer

  3 mg/kg QW
n = 1
10 mg/kg QW
n = 5
20 mg/kg QW
n = 6
40 mg/kg QW
n = 6
40 mg/kg QW
EX, n = 30
20 mg/kg Q2W
n = 6
AUClast, h*μg/mLa 6158 (−) 21,302 (3731) 32,791 (9635) 74,637 (7182) 73,360 (18,819) 52,659 (23,302)
Cmax, μg/mL 65.2 (−) 204 (23.6) 369 (131) 839 (143) 706 (129) 408 (137)
Tmax, h 2.18 (2.18–2.18) 4.00 (2.13–4.53) 3.88 (2.08–5.33) 4.34 (2.42–8.42) 3.79 (2.05–7.5) 3.25 (2.08–4.03)
Tlast, h 168 (168–168) 170 (166–171) 167 (146–169) 167 (166–191) 166 (7.22–171) 334 (261–336)
Clast, μg/mL 21.4 (−) 80.3 (18.4) 115.0 (28.6) 296.0 (66.0) 236.0 (79.7) 82.0 (46.6)
  1. Mean values (standard deviation) provided, except for Tmax and Tlast which are median (range)
  2. AUC, area under curve, EX expansion phase, Q2W once every two weeks, QW once weekly
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