On February 20, 2014 OncoMed announced the initiation of patient treatment for its third multi-center Phase 1b clinical trial of OMP-54F28 (Fzd8-Fc) with carboplatin and paclitaxel in patients with platinum-sensitive ovarian cancer (Press release OncoMed, FEB 20, 2014, View Source [SID:1234500100]).
With the commencement of this clinical study, all six of OncoMed’s planned Phase 1b clinical trials for its proprietary Wnt-pathway-targeting compounds, vantictumab (OMP-18R5) and OMP-54F28, are now enrolling patients. Earlier this year OncoMed initiated two separate Phase 1b clinical trials of OMP-54F28 with nab-paclitaxel (Abraxane) and gemcitabine in pancreatic cancer, and with sorafenib (Nexavar) in hepatocellular cancer. During the fourth quarter of 2013, OncoMed initiated three Phase 1b trials for its anti-Frizzled antibody, vantictumab; in combination with paclitaxel in breast cancer, with nab-paclitaxel and gemcitabine in pancreatic cancer, and with docetaxel in non-small cell lung cancer.
These Phase 1b combination studies will provide critical data for Bayer to exercise their option to license OMP-54F28 and vantictumab and for the planning and execution of Phase 2 clinical studies.”
The Phase 1b clinical trial of OMP-54F28 in combination with carboplatin and paclitaxel is a dose-escalation study in patients with recurrent platinum-sensitive ovarian cancer. Primary objectives of the trial are to evaluate safety of this combination regimen and determine a recommended Phase 2 dose for OMP-54F28 in combination with carboplatin and paclitaxel. Key secondary and exploratory objectives include evaluation of the pharmacokinetics (PK) and pharmacodynamics (PD) of OMP-54F28, as well as the efficacy of this combination. Tumor tissue from patients will be used to explore predictive biomarker hypotheses related to the efficacy of OMP-54F28.
Three additional investigators and clinical sites are participating in this trial: Gina Mantia-Smaldone, M.D., Fox Chase Cancer Center, Philadelphia, PA; Paul Sabbatini, M.D., Memorial Sloan-Kettering Cancer Center, New York, NY; and Nelson Teng, M.D., Stanford University, Palo Alto, CA.