Kainova Therapeutics has dosed the first patient in the European expansion of its DOMISOL phase 1/2 trial of DT 7012, a Treg‑depleting anti‑CCR8 antibody, marking a key step in the company’s global development strategy.
The study, which began in Australia in October 2025, is now enrolling patients at leading oncology centres in France, including Hôpitaux Universitaires de Strasbourg, Institut Gustave Roussy in Paris and Institut Bergonié Bordeaux.
The programme is being led by early‑phase investigators Dr Lauriane Eberst, Professor Antoine Italiano and Dr Maxime Brunet.
Professor Antoine Italiano, Head of Precision Medicine at Institut Gustave Roussy, said: “This study brings together strong clinical expertise and advanced translational capabilities, creating an important opportunity to explore how targeted Treg depletion may translate into meaningful benefit for patients with advanced solid tumours. DT 7012 offers a novel, differentiated approach to precisely address CCR8 biology and reshape the tumour microenvironment.”
Dr Jean Marie Cuillerot, Chief Medical Officer at Kainova Therapeutics, explained: “Dosing of the first patient in Europe marks an important step in the clinical maturation of our flagship program, DT 7012. The DOMISOL study has been designed to generate a comprehensive clinical and biological profile for DT 7012 across both monotherapy and combination settings, including paired biopsies to directly assess the intra tumoral Treg depletion. These data will be essential to inform dose selection and support the next phases of development.”
The multicentre, open‑label trial is assessing DT 7012 as monotherapy in a phase 1 dose‑escalation, in combination with pembrolizumab in a phase 1b dose‑escalation, and in selected tumour types in a phase 2 component focused on clinical efficacy. Primary objectives include determining the maximum tolerated or maximum administered dose and evaluating safety in combination therapy.
A translational research element will analyse paired tumour biopsies to measure intratumoral Treg depletion and demonstrate DT 7012’s mechanism of action.
Sean A MacDonald, Chief Executive Officer of Kainova Therapeutics, added: “As our flagship program, DT 7012 is central to Kainova Therapeutics’ strategy and reflects our commitment to advancing breakthrough GPCR modulating therapies in immuno oncology and inflammation.
“With multiple high value milestones ahead, 2026 is a pivotal year for Kainova Therapeutics. We are excited to expand the DOMISOL trial into Europe and we look forward to sharing compelling data in the coming quarters.”
