Kainova Therapeutics Expands Phase I / II Trial of DT-7012, a Treg-depleting Anti-CCR8 Antibody, with First Patient Dosed in Europe

Montreal, Canada – Strasbourg, France – Boston, United States, April 9, 2026: Kainova Therapeutics ( “the Company” ), a key player for breakthrough treatments in immuno-oncology and inflammation, today announced dosing of the first patient in the European expansion of its DOMISOL Phase I / II clinical trial evaluating DT‑7012, a proprietary Treg‑depleting anti‑CCR8 monoclonal antibody, in patients with advanced solid tumors.

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 ( NCT06819735 ) 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, MD PhD, 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. These data will be essential to inform dose selection and support the next phases of development.”

The Phase I / II multicenter, open‑label DOMISOL clinical study is evaluating DT‑7012 as monotherapy in a Phase I dose-escalation, in combination with the immune checkpoint inhibitor pembrolizumab in a Phase Ib dose-escalation in patients with advanced solid tumors, and in selected tumor types in a Phase II component focused on clinical efficacy. The primary objectives include determining the maximum tolerated dose ( MTD ) or maximum administered dose ( MAD ) of DT‑7012 as monotherapy and assessing the safety and tolerability of DT‑7012 in combination with pembrolizumab.

The study also includes a translational research program with paired tumor biopsies to evaluate intratumoral Treg depletion induced by DT‑7012, providing a direct demonstration of DT-7012’s mechanism of action to turn the immunosuppressive tumor microenvironment into an immunocompetent one.

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.”

ENDS

For more information, please contact:
Optimum Strategic Communications
Mary Clark, Zoe Bolt, Elena Bates, Nellie Stephens
+44 (0) 203 882 9621
kainova@optimumcomms.com

For French media:
communication@kainovatx.com

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