Phase 1 clinical trial DKN-01in combination with chemo agents gemcitab

Study of DKN-01 and Gemcitabine/Cisplatin in Patients With Carcinoma to Primary to the Intra- or Extra-Hepatic Biliary System or Gallbladder

https://clinicaltrials.gov/ct2/show/NCT02375880

21 evaluable patients received a 300 mg regimen of DKN-01 plus chemo, 33% (n=7/21) were partial responders. Additionally, the disease control rate (partial responders + those with stable disease) was 95% (n=20/21). Median progression-free survival (PFS) and overall survival (OS) have yet to be reached.
The combination regimen was safe and well-tolerated with no reported serious adverse events or dose-limiting toxicities.

DKN-01 is a humanized IgG4 monoclonal antibody that binds to Dickkopf-1 (DKK1), a protein associated with a poor prognosis in a range of cancers. Specifically, it inhibits a pathway called canonical Wnt/Beta-catenin which plays a key role in embryonic development, cell proliferation and differentiation.