Table 3.

Patient outcomes

Tumor typePatient (HER2 level)Dose level IL-12, 100 ng/kg i.v., 300 ng/kg i.v., 200 ng/kg s.c.No. cycles receivedBest responseDuration of response or SD (d)Peak IFN-γ level (pg/mL)
BreastA (3+)10018SD*475363
BreastB (3+)10015PR329285
BreastC (3+)1006PR128686
ColorectalD (3+)3003SD143174
BreastE (3+)3002PD0
ColorectalF (2+)3003PD0
BreastG (3+)3003CR§1,643+1,448
BreastH (2+)3006SD126124
EsophagusI (2+)30012PR3031,612
ColorectalJ (3+)2003PD0
ColorectalK (2+)2003SD100183
ColorectalL (2+)2003PD0
StomachM (2+)20015SD435331
ThyroidN (2+)2002PD0
PancreasO (2+)2003PD0
BreastP (3+)2002PD0
StomachQ (2+)2009SD191128
EsophagusR (2+)2003PD0
EsophagusS (2+)2003PD0
EsophagusT (3+)2008PR177262
ColorectalU (2+)2003PD0
  • *Patient completed the study and was continued on single agent trastuzumab until disease progression.

  • Patient was lost to follow-up.

  • Experienced grade 3 fatigue that was dose-limiting.

  • §Patient was removed from study because of an incidental pulmonary embolism found on CT scan. The patient is receiving trastuzumab alone and is NED as of this writing.