Table 2.

Dose escalation scheme

Dose level, mg/kgNo. of patientsNo. of completed cyclesPatients with DLTa
NewModified to levelbTotalFirst cyclecAll cyclesd
≤1.0 qw132c 15471/131/15
2.0 qw81c 9200/80/9
2.0 q2w617170/60/7
3.0 qw606102/62/6
3.0 q2w606111/64/6
Total39105
  • aDLT or DLT equivalent (AE meeting DLT criteria but occurring past cycle 1).

  • bPatients whose doses were dose reduced for AEs.

  • cPatient 2003 started at 3.0 mg/kg per week for 3 cycles and was dose reduced to 2.0 mg/kg per week for 1 dose and then to 1.0 mg/kg per week thereafter due to AE.

  • dNo. of patients with DLT/no. of patients treated at dose level.