Table 4 The trough (Cmin) and end of infusion (Ceoinf) concentrations of SHR-1210 after the first dose (C1D1) and the dose at steady state (C5D1) and the corresponding accumulation index (AI)

From: Safety, anti-tumour activity, and pharmacokinetics of fixed-dose SHR-1210, an anti-PD-1 antibody in advanced solid tumours: a dose-escalation, phase 1 study

Dose (mg)

Dose regimen

n

Cmin (μg/mL) geomean (CV%)

Ceoinf (μg/mL) geomean (CV%)

AI Cmin (μg/mL) geomean (CV%)

AI Ceoinf (μg/mL) geomean (CV%)

60

1st infusion in C1

12

0.75 (83.83)a

20.01 (22.67)

2.54 (49.60)b

1.08 (7.54)

1st infusion in C5

7

1.48 (124.88)

19.22 (13.34)

  

200

1st infusion in C1

12

9.94 (28.32)c

70.02 (23.31)

2.56 (12.84)

1.23 (21.46)

1st infusion in C5

5

29.78 (31.64)

92.66 (31.64)

  

400

1st infusion in C1

11

25.84 (26.78)d

121.43 (16.66)

3.07 (6.68)

1.53 (13.60)

1st infusion in C5

5

70.50 (32.23)e

184.03 (11.64)

  
  1. Only 1 infusion was administered in C1 (4 weeks); Q2W dosing starts from C2.
  2. AI accumulation index, calculated as concentration (Cmin or Ceoinf) at C5 divided by the corresponding concentration at C1 of each dose, C Cycle, Cminday 14 concentration at C1 and C5, CV% coefficient of variation %, n number of subjects contributing to the mean, Q2W every 2 weeks.
  3. an = 11
  4. bn = 6
  5. cn = 11
  6. dn = 10
  7. en = 4
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