Kainova Therapeutics has dosed the first European patient in its Phase 1/2 DOMISOL study of DT-7012, a Treg-depleting anti-CCR8 antibody being developed for advanced solid tumours, expanding the trial beyond its initial start in Australia.

The first European dosing took place in France, marking the expansion of the global clinical programme evaluating DT-7012 both as a monotherapy and in combination with pembrolizumab in patients with advanced cancers.

The DOMISOL study, which began in Australia in 2025, is a multicentre Phase 1/2 trial designed to assess safety, tolerability and early signs of efficacy for DT-7012 across multiple tumour types. The programme also includes a Phase 2 expansion component focused on selected indications.

Sites in France include Hôpitaux Universitaires de Strasbourg, Institut Gustave Roussy in Paris, and Institut Bergonié in Bordeaux, with early-phase investigators involved in patient recruitment and trial oversight.

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 tumors.”

The trial includes both dose-escalation and combination cohorts, with DT-7012 being evaluated alongside the PD-1 inhibitor pembrolizumab. Primary endpoints include determination of maximum tolerated dose or maximum administered dose, alongside safety and tolerability assessments.

A translational research component is also embedded in the study, using paired tumour biopsies to assess intratumoural regulatory T cell depletion and explore changes in the tumour microenvironment.

Jean-Marie Cuillerot, chief medical officer at Kainova Therapeutics, said: “Dosing of the first patient in Europe marks an important step in the clinical maturation of our flagship program, DT-7012.”

He added that the study is designed to generate both clinical and biological data to support dose selection and future development decisions.

DT-7012 is part of a broader immuno-oncology strategy at Kainova focused on modulating the tumour immune environment through CCR8 targeting, with the aim of enhancing anti-tumour immune responses.

Sean A MacDonald, chief executive officer of Kainova Therapeutics, said: “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.”

He added that 2026 will be a key year for clinical readouts from the programme as the trial expands geographically.

The company is positioning DT-7012 as part of a next-generation immunotherapy approach targeting regulatory T cells within tumours, with early-stage clinical work now extending across multiple regions.