Kainova Therapeutics doses first European patient in the Phase I/II DOMISOL trial evaluating DT-7012, a Treg-depleting anti-CCR8 antibody, alone and with pembrolizumab in advanced solid tumors.
Written By: Dr. Anuja Badgujar, BDS
Reviewed By: Pharmacally Editorial Team
Kainova Therapeutics has dosed the first patient in the European expansion of the Phase I/II DOMISOL clinical trial (NCT06819735) evaluating DT-7012, a Treg-depleting anti-CCR8 monoclonal antibody, in patients with advanced solid tumors. The move extends the study beyond its initial launch in Australia in October 2025 and marks a new step in the global development of the company’s lead immuno-oncology program.
The European expansion includes oncology centers in France, with early-phase investigators leading enrollment. Participating institutions include Hôpitaux Universitaires de Strasbourg, Institut Gustave Roussy in Paris, and Institut Bergonié Bordeaux. The study is designed to explore targeted regulatory T-cell (Treg) depletion and its potential to reshape the tumor microenvironment.
Professor Antoine Italiano, Head of Precision Medicine at Institut Gustave Roussy, stated that the study combines clinical expertise with translational research capabilities. He noted that DT-7012 represents a differentiated approach to targeting CCR8 biology and evaluating whether selective Treg depletion can produce meaningful benefit in advanced solid tumors.
The DOMISOL trial (NCT06819735) is a Phase I/II multicenter, open-label study assessing DT-7012 as monotherapy in a Phase I dose-escalation stage and in combination with the immune checkpoint inhibitor pembrolizumab in a Phase Ib dose-escalation. A Phase II component will evaluate clinical efficacy in selected tumor types. Primary objectives include determining the maximum tolerated dose or maximum administered dose and assessing safety and tolerability, both alone and in combination.
The study also incorporates a translational research program using paired tumor biopsies to measure intratumoral Treg depletion. This approach aims to directly demonstrate the mechanism of action of DT-7012 and evaluate its ability to convert an immunosuppressive tumor microenvironment into an immunocompetent one.
Jean-Marie Cuillerot, Chief Medical Officer of Kainova Therapeutics, said that dosing the first European patient represents an important step in advancing the company’s flagship program. He emphasized that the study is designed to generate both clinical and biological data across monotherapy and combination settings, supporting dose selection and future development.
Sean A. MacDonald, Chief Executive Officer of Kainova Therapeutics, described DT-7012 as central to the company’s strategy focused on GPCR-modulating therapies in immuno-oncology and inflammation. He added that expansion into Europe positions the program for multiple development milestones anticipated during 2026.
Reference
Kainova Therapeutics Expands Phase I / II Trial of DT-7012, a Treg-depleting Anti-CCR8 Antibody, with First Patient Dosed in Europe, 09 April 2026, https://www.kainovatx.com/en/press-releases/kainova-therapeutics-expands-phase-i-ii-trial-of-dt-7012-a-treg-depleting-anti-ccr8-antibody-with-first-patient-dosed-in-europe/
Study of DT-7012 as a Single Agent and in Combination with an Immune Checkpoint Inhibitor in Participants with Advanced Solid Tumors (DOMISOL), ClinicalTrials.gov ID NCT06819735, https://clinicaltrials.gov/study/NCT06819735
About the Writer
Dr. Anuja Badgujar, BDS is a dentist with expertise in US healthcare data and medical data annotation. With four years of experience handling US healthcare datasets, she brings strong domain knowledge and precision to her work. She is also deeply passionate about medical writing, with a focus on translating complex medical information into clear and structured content.