(PM-01) IMPRIME PGG® With BTH1704 and Gemcitabine for Advanced Pancreatic Cancer
Status:
Terminated
Trial end date:
2015-04-01
Target enrollment:
Participant gender:
Summary
This Phase Ib dose escalation study will evaluate BTH1704, a monoclonal antibody that targets
an aberrantly glycosylated antigen Mucin 1, and Imprime PGG, a glucan contained in yeast that
is essential in triggering a leukocyte-mediated cytotoxic response towards tumor cells, in
combination with gemcitabine in patients with advanced PDAC. The three intravenous drugs are
taken in tandem 4 times in a 28-day cycle. The MAD of BTH1704 (BTH, 3 dose levels) in
combination with gemcitabine (Gem) and Imprime PGG (I) will be determined using a standard
"3+3" design. Treatment continues until disease progression, unacceptable toxicity, physician
discretion, or patient refusal.