An Open-Label Phase 2 Study of AGS-1C4D4 in Pancreatic Cancer Subjects Previously Treated in Protocol 2008002
Subjects will receive a maintenance dose of AGS-1C4D4 every 3 weeks (Q3W) in addition to the
gemcitabine administration. If subjects have grade 4 adverse events considered to be
related to AGS-1C4D4 at anytime during the study, AGS-1C4D4 treatment will be discontinued
for that subject.
Subjects will continue to have their tumor status assessed by computerized tomography (CT)
and magnetic resonance (MRI) scans according to Response Evaluation Criteria in Solid Tumors
(RECIST Version 1.1) guidelines every eight weeks (Q8W). Subjects without evidence of
disease progression will continue to receive AGS-1C4D4 and gemcitabine until intolerability,
disease progression or consent withdrawal.
Subjects who discontinue AGS-1C4D4 for any reason will undergo an end of study visit 4 weeks
after their last AGS-1C4D4 infusion.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Incidence of adverse events
Grade 3 and 4 adverse events, treatment-related adverse events, serious adverse events and adverse events requiring discontinuation of AGS-1C4D4
United States: Food and Drug Administration
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