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Table 1 Pharmacokinetic parameters for MGAH22 and RES120 in cynomolgus monkeys

From: Anti-tumor activity and toxicokinetics analysis of MGAH22, an anti-HER2 monoclonal antibody with enhanced Fcγ receptor binding properties

Study Monoclonal antibody Dose, mg/kg Sex Cmax, mg/mL AUC0-¥, mg-hour/mL T1/2b, days Clearance, mL/hour Vss, mL
Single-dose RES120 50 Male 1.40 ± 0.32 285.7 ± 4.2 11.7 ± 2.4 0.44 ± 0.01 170 ± 36
    Female 1.43 ± 0.05 311.8 ± 54.6 12.0 ± 2.3 0.41 ± 0.07 158 ± 15
  MGAH22 50 Male 1.62 ± 0.10 294.1 ± 53.2 9.3 ± 1.8 0.43 ± 0.07 132 ± 2
    Female 1.70 ± 0.14 314.2 ± 31.3 9.7 ± 1.1 0.40 ± 0.04 127 ± 8
Repeat-dose MGAH22 (first dose) 15 Male 0.43 ± 0.06 57.0 ± 11.2 5.6 ± 2.0 0.82 ± 0.18 148 ± 35
    Female 0.43 ± 0.40 42.8 ± 9.7 5.1 ± 1.2 1.09 ± 0.24 144 ± 27
   50 Male 1.37 ± 0.23 205.7 ± 127.0 6.9 ± 5.0 0.82 ± 0.28 161 ± 24
    Female 2.85 ± 1.37 286.6 ± 98.2 6.6 ± 4.8 0.57 ± 0.21 109 ± 46
   150 Male 4.10 ± 0.49 558.1 ± 168.6 7.3 ± 3.7 0.78 ± 0.23 176 ± 60
    Female 6.22 ± 1.44 882.9 ± 347.7 7.9 ± 3.6 0.55 ± 0.32 127 ± 34
  MGAH22 (sixth dose) 15 Male 0.89 ± 0.11 229.8 ± 82.1 8.9 ± 4.3 0.24 ± 0.12 66 ± 6
    Female 0.98 ± 0.33 209.4 ± 110.4 8.7 ± 4.6 0.29 ± 0.16 90 ± 51
   50 Male 4.90 ± 5.34 975.5 ± 747.1 8.8 ± 3.0 0.22 ± 0.13 65 ± 34
    Female 7.20 ± 5.70 1,040.4 ± 657.6 7.3 ± 4.7 0.20 ± 0.12 41 ± 18
   150 Male 6.87 ± 1.64 1,330.3 ± 456.7 7.3 ± 3.0 0.36 ± 0.13 81 ± 14
    Female 11.00 ± 4.89 1,963.5 ± 1,273.1 8.8 ± 2.4 0.31 ± 0.19 73 ± 36
  1. Data are presented as mean ± standard deviation. AUC0-¥, area under the curve from zero to infinity; Cmax, maximal serum concentration; MGAH22, chimeric anti-HER2 monoclonal antibody with an optimized Fc domain; RES120, chimeric anti-HER2 monoclonal antibody with wild-type human immunoglobulin G 1 Fc domain; T1/2β, elimination half-life; Vss, volume of distribution at steady state.