DUE Diligence break #2

these data will be out before yearend!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

• Change in tumor size [ Time Frame: baseline and 2 months ] [ Designated as safety issue: No ]
  
  Change in tumor size based on RECIST criteria version 1.1. using MRI, CT scan, and/or standard of care imaging
  
  
  


• Change in tumor size [ Time Frame: baseline and 4 months ] [ Designated as safety issue: No ]
  
  Change in tumor size based on RECIST criteria version 1.1. using MRI, CT scan, and/or standard of care imaging
  
  
  


• Change in tumor size [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
  
  Change in tumor size based on RECIST criteria version 1.1. using MRI, CT scan, and/or standard of care imaging
  
  
  


• Decrease in serum tumor marker [ Time Frame: baseline and 1 month ] [ Designated as safety issue: No ]
  
  A decrease in a tumor marker in the serum may also suggest evidence of anti-tumor efficacy. The following tumor markers will be evaluated: Carcinoembryonic antigen (CEA), Cancer Antigen 125 (CA125), Cancer Antigen 19-9 (CA19-9), Cancer Antigen 15-3 (CA15-3), ProstateSpecific Antigen (PSA), or other appropriate markers. The choice of the individual tumor markers will be based on the type of tumor of thepatient and the testing that has preceded the patient's participation in this study.
  
  
  


• Decrease in serum tumor marker [ Time Frame: baseline and 2 months ] [ Designated as safety issue: No ]
  
  A decrease in a tumor marker in the serum may also suggest evidence of anti-tumor efficacy. The following tumor markers will be evaluated: Carcinoembryonic antigen (CEA), Cancer Antigen 125 (CA125), Cancer Antigen 19-9 (CA19-9), Cancer Antigen 15-3 (CA15-3), ProstateSpecific Antigen (PSA), or other appropriate markers. The choice of the individual tumor markers will be based on the type of tumor of thepatient and the testing that has preceded the patient's participation in this study.