Clinical-stage company OncoMed Pharmaceuticals has commenced an open-label dose escalation and expansion Phase 1 study of OMP-52M51, designed for the treatment of advanced, refractory solid tumours.
OMP-52M51, which the company's fifth product candidate, is a proprietary monoclonal antibody that targets the Notch1 receptor.
During the company's preclinical studies, OMP-52M51 has shown to exhibit substantial anti-tumour and anti-cancer stem cells (CSCs) activity in Notch-dependent hematologic malignancies and solid tumours.
The trial, which is being conducted at US several sites including the South Texas Accelerated Research Therapeutics (START), will assess the safety, pharmacokinetics, pharmacodynamics and initial evidence of efficacy of the product candidate.
The trial will also demonstrate a predictive biomarker-based patient selection approach.
START clinical research associate director Dr Amita Patnaik said: "It is exciting to begin a clinical with a novel anti-cancer stem cell mechanism of action to patients with advanced solid tumours."
OncoMed Pharmaceuticals president and chief executive officer Paul Hastings said that the company's several other candidates are also advancing towards phase 2 testing.
"We look forward to generating important clinical data with Anti-Notch1 and our other novel agents that target cancer stems cells," Hastings added.
OncoMed said OMP-52M51 product forms part the company's strategic collaboration with GlaxoSmithKline to discover and develop novel product candidates targeting CSCs via Notch pathway signalling modulation.
As part of the deal, GSK retains an option through the end of certain Phase 1 or certain Phase 2 clinical trials to obtain an exclusive license to OMP-52M51.