VentiRx Pharmaceuticals has started the ACTIVE8 Phase II trial to assess small molecule Toll-like Receptor 8 (TLR8) agonist, VTX-2337, in combination with Cetuximab and chemotherapy in patients with recurrent or metastatic squamous cell carcinoma of the head and neck.

A total of 175 patients will be randomised in the placebo-controlled study with either VTX-2337 or placebo in combination with cetuximab, platinum and 5-FU chemotherapy.

The study will be conducted in approximately 50 centres throughout the US, with progression-free survival as determined by Immune Related Response Evaluation Criteria in Solid Tumours (irRECIST) as its primary endpoint.

The University of Chicago medicine associate professor and study co-chair Dr Ezra Cohen said the initiation of the trial allows the combination of VTX-2337 with a current standard of care treatment in the first-line setting of recurrent head and neck cancer.

"Given the preclinical and early clinical data with VTX-2337 in SCCHN, we are hopeful that ACTIVE8 will provide meaningful benefits in this population who currently have few treatment options," Cohen added.

By directly activating multiple components of the innate immune system, including activation of human myeloid dendritic cells (mDCs), monocytes and natural killer (NK) cells, VTX-2337 produces high levels of mediators known to organise the integration of innate and adaptive anti-tumour responses.

Preclinical studies indicate that the combination of VTX-2337 with some chemotherapies and monoclonal antibodies demonstrate a synergistic effect in stimulating immune pathways associated with anti-tumour activity.

An ongoing Phase I trial in squamous cell carcinoma of the head and neck demonstrated the safety of the combination and activation of NK cells subsequent to VTX-2337 dosing.

VentiRx president and chief executive officer Robert Hershberg said, "The ACTIVE8 study in head and neck cancer patients focuses on the ability of our novel TLR8 agonist to stimulate NK cells, ADCC and monoclonal antibody responses."