Kainova Therapeutics expands phase I/II trial of antibody drug
pharmafile | April 7, 2026 | News story | Research and Development |
Kainova Therapeutics has announced that the first patient in the European expansion of its DOMISOL phase I/II clinical trial evaluating DT‑7012 has been dosed.
Kainova focuses on breakthrough treatments in immuno-oncology and inflammation, and DT‑7012 is a proprietary Treg‑depleting anti‑CCR8 monoclonal antibody for patients with advanced solid tumours.
This dosing follows the initiation of the DOMISOL phase I/II study in Australia, announced in October 2025, marking a significant milestone in the global clinical development of DT‑7012, Kainova Therapeutics’ lead immuno-oncology program.
The European expansion includes leading oncology centers in France, led by renowned early-phase clinical investigators, including Dr Lauriane Eberst at Hôpitaux Universitaires de Strasbourg, Professor Antoine Italiano at Institut Gustave Roussy in Paris, and Dr Maxime Brunet at Institut Bergonié Bordeaux.
Professor Antoine Italiano, Head of Precision Medicine at Institut Gustave Roussy and member of Kainova Therapeutics’ Scientific Advisory Board, 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. DT‑7012 offers a novel, differentiated approach to precisely address CCR8 biology and reshape the tumor microenvironment.”
Dr Jean‑Marie Cuillerot, Chief Medical Officer of Kainova Therapeutics, commented: “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. This data will be essential to inform dose selection and support the next phases of development.”
The phase 1/2 multicentre, open‑label Domisol clinical study is evaluating DT‑7012 as monotherapy in a phase 1 dose-escalation, in combination with the immune checkpoint inhibitor pembrolizumab in a phase 1b dose-escalation in patients with advanced solid tumors, and in selected tumor types in a phase 2 component focused on clinical efficacy.
