OncoMed Pharmaceuticals has initiated a multi-centre Phase Ib clinical trial of its first-in-class Wnt-pathway-targeting decoy receptor OMP-54F28 (Fzd8-Fc) with nab-paclitaxel (Abraxane) and gemcitabine in pancreatic cancer.
The trial is the first of three Phase Ib trials for OMP-54F28 scheduled to commence patient enrolment in the next few months as part of the company’s deal with Bayer Pharma.
The Phase Ib trial is a dose escalation study of OMP-54F28 in combination with nab-paclitaxel and gemcitabine to treat patients with first-line Stage IV pancreatic cancer.
The primary objectives are to assess the safety of the combination regimen and determine a recommended Phase II dose for OMP-54F28 in combination with nab-paclitaxel and gemcitabine.
Major secondary and exploratory objectives include assessment of the pharmacokinetics (PK) and pharmacodynamics (PD) of OMP-54F28, as well as the efficacy of the combination.
The company said that tumour tissue from patients will be utilised to explore predictive biomarker hypotheses related to the efficacy of OMP-54F28.
The University of Colorado assistant professor Colin Weekes said metastatic pancreatic cancer is a devastating disease and these patients are in need of additional therapeutic options.
"OMP-54F28 has shown impressive combination efficacy with Abraxane and gemcitabine in preclinical models for pancreas cancer," said Weekes.
The first Phase Ib trial for OMP-54F28 will be followed shortly by two additional Phase Ib trials.
OncoMed chairman and chief executive officer Paul Hastings said the start of the Phase Ib programme for OMP-54F28, so quickly after starting three Phase Ib combination trials for vantictumab, brings the company closer to its goal of having all six Phase Ib combination trials for its Wnt pathway programme up and running in early 2014.
"Data generated from these studies will serve to inform future Phase 2 trials and provide the basis for Bayer to exercise their option to license OMP-54F28 and vantictumab," Hastings said.
The company has recently released interim results for the single-agent, first-in-human Phase Ia trial for OMP-54F28 which showed that OMP-54F28 is well tolerated and modulates the Wnt pathway starting at low doses, as evidenced by PD biomarker analysis of hair follicles.
In addition, the company has recently started Phase Ib trials for its other Wnt-pathway-targeting product candidate, vantictumab, in HER2-negative breast cancer, non-small cell lung cancer and pancreatic cancer.
Image: OncoMed’s Phase Ib trial of OMP-54F28 in combination with nab-paclitaxel and gemcitabine is indicated for treatment of patients with pancreatic cancer. Photo: courtesy of dream designs/ www.freedigitalphotos.net.