US-based OncoMed Pharmaceuticals has initiated a multi-centre Phase Ib clinical trial of its first-in-class Wnt-pathway-targeting antibody vantictumab (OMP-18R5) with docetaxel to treat patients with second- and third-line advanced non-small cell lung cancer (NSCLC) tumours.
The trial is the second of three Phase Ib trials for vantictumab that the company intends to start in 2013 as part of its collaboration with Bayer Pharma.
The primary objectives of the Phase Ib clinical trial are to assess safety of the combination regimen and determine a recommended Phase II dose for vantictumab in combination with docetaxel.
Secondary and exploratory objectives of the trial include assessment of the pharmacokinetics (PK) and pharmacodynamics (PD) of vantictumab and the efficacy of the combination.
In the trial, tumour tissue from patients will be used to explore predictive biomarker hypotheses related to the efficacy of vantictumab.
Roswell Park Cancer Institute associate professor Grace Dy is the principal investigator who treated the first patient enrolled in the trial.
Dy said that vantictumab could offer a novel therapeutic approach to lung cancer by targeting the Wnt pathway which may play a significant role both in squamous and non-squamous cell lung cancers.
"Patients with lung cancer continue to be in need of better therapies, and we are excited about testing the combination of vantictumab with docetaxel in this clinical study based on preclinical data and the strong emphasis on tumour tissue analysis in the study," Dy added.
OncoMed chief medical officer Jakob Dupont said that advanced recurrent non-small cell lung cancer remains an area of medical need.
"We are pleased to initiate this trial combining vantictumab, with its novel anti-cancer stem cell mechanism of action, with standard docetaxel chemotherapy, and our preclinical studies have generated robust anti-tumour activity data for this combination," Dupont said.
According to the company, the trial will provide the safety, biomarker effects, and potential efficacy of the novel Wnt pathway-targeting drug candidate in combination with chemotherapy in advanced NSCLC.
In October 2013, the company started a multi-centre Phase Ib clinical trial of vantictumab (OMP-18R5) in combination with paclitaxel to treat patients with first, second and third-line, locally advanced or metastatic HER2 negative breast cancer.
Results from a previously conducted Phase Ia study showed that vantictumab is well tolerated with early evidence of single agent activity.
Vantictumab, which is part of OncoMed's collaboration with Bayer Pharma, is a first-in-class antibody that has shown broad anti-CSC and anti-tumour activity in patient-derived xenograft tumour models.