Table 1.
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 |