Table 3

The relationship of HAHA to the biodistribution of [131I]Sibrotuzumab, pharmacokinetics, and adverse events related to sibrotuzumab

Patient IDDose group (mg/m2)No. of infusions givenInfusion number at which HAHA first detectablePeak HAHA levelChange in PK?Change in biodistribution?Related AE?
ELISABiacoreELISA (μg/ml)Biacore (RU)a
1375126517.9490YYN
13852FUFU0.25107YNDN
13955431.84741YYYb
142512991.68109YYN
102108650.122139YYYc
106255630.032157YYN
146258880.372150YNDYb
129504FU40.53113YNDYd
cutoff:0.0226
  • a Abbreviations: RU, response units; ND, not determined—patients taken off study between positive HAHA result and next [131I]sibrotuzumab infusion; Y, Yes; N, No; AE, adverse event; PK, pharmacokinetics; FU, 30 day follow-up sample after final infusion.

  • b CTC Grade 2.

  • c CTC Grade 1.

  • d CTC Grade 3 (back pain).