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. 2020 Nov 5;42(8):1368–1375. doi: 10.1038/s41401-020-00550-y

Table 1.

Summary of clinical trials used in this population pharmacokinetic modeling study

Study Dosing regimen Indication Number of subjects Number of PK samples Scheduled PK time points
SHR-1210-101

1 mg/kg, 3 mg/kg, 10 mg/kg and 200 mg.

Cycle 1: 28 days;

Cycle 2 and subsequent cycles: every 2 weeks

Advanced solid tumors 49 1140

Cycle 1: 30 min before and 0.1, 2, 6, 24, 48, 168, 336, 504 h after end of infusion on day 1

Cycle 2 and subsequent cycles: 30 min before and 0.1 h after end of infusion on day 1 and 15

SHR-1210-102

60 mg, 200 mg and 400 mg.

Cycle 1: 28 days;

Cycle 2 and subsequent cycles: every 2 weeks

Advanced melanoma 36 986 Same as the study SHR-1210-101
SHR-1210-103

60 mg, 200 mg and 400 mg.

Cycle 1: 28 days;

Cycle 2 and subsequent cycles: every 2 weeks

Advanced solid tumors 36 1052 Same as the study SHR-1210-101
SHR-1210-II-204 200 mg, Q2W Relapsed or refractory classical Hodgkin lymphoma 12 120

Cycle 1: 30 min before and 0.1, 2 h after end of infusion

Cycle 2, Cycle 4 and Cycle 6: 30 min before and 0.1 h after end of infusion