Kainova Therapeutics has dosed the first patient in Europe in its phase 1/2 DOMISOL study evaluating DT-7012, a Treg-depleting anti-CCR8 monoclonal antibody, in patients with advanced solid tumours.

The European dosing, conducted in France, expands the study beyond its initial start in Australia in 2025. The programme is assessing DT-7012 as both monotherapy and in combination with the PD-1 inhibitor pembrolizumab in patients with advanced solid tumours.

The multicentre, open-label study includes a phase 1 dose-escalation monotherapy arm, a phase 1b combination arm, and a phase 2 expansion cohort evaluating selected tumour types. Primary endpoints include safety, tolerability, and determination of the maximum tolerated dose or maximum administered dose.

The study also includes translational analyses with paired tumour biopsies to assess intratumoral regulatory T cell (Treg) depletion and changes in the tumour microenvironment.

Investigators involved in the European expansion include teams at Hôpitaux Universitaires de Strasbourg, Institut Gustave Roussy in Paris, and Institut Bergonié in Bordeaux.

DT-7012 targets CCR8-expressing regulatory T cells, which are linked to immunosuppressive activity within the tumour microenvironment. The approach is designed to enhance anti-tumour immune responses by reducing local immune suppression.

“The DOMISOL study has been designed to generate a comprehensive clinical and biological profile of DT-7012 across monotherapy and combination settings,” said Jean-Marie Cuillerot, chief medical officer of Kainova Therapeutics.

The company said the European expansion marks a key step in the global development of DT-7012, with further clinical data expected as the study progresses.