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. 2021 Jul 11;39(6):1604–1612. doi: 10.1007/s10637-021-01145-y

Table 1.

Patient disposition

Dose, mg/kg n Reason for withdrawal
Dose escalation (n = 26) Not dosed 1 Other (patient enrolled but not included in the safety population)
3.2 6 PD (n = 2), AE (n = 2), symptomatic deterioration (n = 2)
6 3 PD (n = 2), death (n = 1)
10 4 PD (n = 3), symptomatic deterioration (n = 1)
15 3 PD (n = 2), withdrew consent (n = 1)
20 5 PD (n = 2), withdrew consent (n = 1), symptomatic deterioration (n = 2)
40/20 4 PD (n = 3), symptomatic deterioration (n = 1)
Dose expansion (n = 18) 40/20 18 PD (n = 14), investigator decision (n = 1), symptomatic deterioration (n = 3)

40/20 40 mg/kg loading dose followed by 20 mg/kg maintenance dose, AE adverse event, PD progressive disease