US-based OncoMed Pharmaceuticals has started dosing patients in the Phase Ia clinical trial of anti-TIGIT (OMP-313M32) to treat advanced or metastatic solid tumours.
OMP-313M32 is an immuno-oncology therapeutic candidate being developed to prevent immune system suppression, as well as induce anti-tumour activity.
The open-label Phase Ia trial will evaluate the safety and tolerability of increasing doses of anti-TIGIT administered as a monotherapy every two weeks in up to 30 patients at five clinical sites.
OncoMed clinical research and development senior vice-president Robert Stagg said: “In multiple preclinical studies of anti-TIGIT antibodies, we have observed immune activation and single-agent, as well as combination anti-tumour activity, including indications that an anti-TIGIT antibody induced a long-term immune memory response.
“The initiation of this Phase Ia anti-TIGIT study represents the first of our novel immuno-oncology therapeutics to enter clinical trials.
"We believe that by blocking TIGIT signalling, our anti-TIGIT antibody may enable T-cell activation and facilitate anti-tumour immune responses with the potential to impact tumour growth.”
The trial's secondary objectives include anti-TIGIT's pharmacokinetics, immunogenicity and anti-tumour efficacy.
The pharmacodynamic and potential predictive biomarkers for changes in immune system activation will also be assessed.
Anti-TIGIT trial lead investigator Johanna Bendell said: “The immuno-suppressive receptor TIGIT is expressed in many different tumour types, giving us reason to believe that an anti-TIGIT antibody such as OncoMed’s OMP-313M32 has the potential for broad activity in cancer patients."
An expansion cohort will recruit patients with select tumour types, following the determination of a maximum-tolerated dose.