Kainova Therapeutics Expands Phase I/II Trial of DT-7012 Antibody to Europe

First patient dosed in France as part of global DOMISOL study evaluating Treg-depleting anti-CCR8 therapy

Apr. 9, 2026 at 7:49am

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A ghostly, translucent X-ray photograph revealing the intricate web-like structures of a human lymph node, conceptually representing the immune cell interactions within the tumor microenvironment.An X-ray view into the complex immune landscape of the tumor microenvironment, where Kainova's DT-7012 antibody aims to selectively deplete immunosuppressive regulatory T cells.Boston Today

Kainova Therapeutics, a clinical-stage biopharmaceutical company, has dosed the first patient in Europe as part of the 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. The European expansion includes leading oncology centers in France, led by renowned early-phase clinical investigators.

Why it matters

DT-7012 is Kainova's lead immuno-oncology program, designed to selectively deplete highly immunosuppressive regulatory T cells (Tregs) within the tumor microenvironment by targeting CCR8. This approach aims to restore immune competence and potentially benefit patients unresponsive to existing immunotherapies.

The details

The Phase I/II DOMISOL study is evaluating DT-7012 as monotherapy in a dose-escalation phase, in combination with the immune checkpoint inhibitor pembrolizumab, and in selected tumor types in a Phase II component focused on clinical efficacy. The study also includes a translational research program with paired tumor biopsies to evaluate intratumoral Treg depletion induced by DT-7012.

  • The DOMISOL study was first initiated in Australia in October 2025.
  • The European expansion (NCT06819735) has now begun with the dosing of the first patient in France.

The players

Kainova Therapeutics

A clinical-stage biopharmaceutical company headquartered in Montreal, Canada, driving a robust pipeline of breakthrough therapies that precisely modulate G protein-coupled receptors (GPCRs) with a focus on immuno-oncology and inflammation.

DT-7012

Kainova's clinical-stage, differentiated immunotherapy candidate designed to selectively deplete highly immunosuppressive regulatory T cells (Tregs) within the tumor microenvironment by targeting CCR8.

Professor Antoine Italiano

Head of Precision Medicine at Institut Gustave Roussy and member of Kainova Therapeutics' Scientific Advisory Board.

Dr. Jean-Marie Cuillerot

Chief Medical Officer of Kainova Therapeutics.

Sean A. MacDonald

Chief Executive Officer of Kainova Therapeutics.

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What they’re saying

“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.”

— Professor Antoine Italiano, Head of Precision Medicine at Institut Gustave Roussy and member of Kainova Therapeutics' Scientific Advisory Board

“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.”

— Dr. Jean-Marie Cuillerot, Chief Medical Officer of Kainova Therapeutics

“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.”

— Sean A. MacDonald, Chief Executive Officer of Kainova Therapeutics

What’s next

The DOMISOL Phase I/II study will continue to enroll patients at leading oncology centers in France, with data expected to be shared in the coming quarters.

The takeaway

Kainova Therapeutics' expansion of its DOMISOL trial for the Treg-depleting antibody DT-7012 into Europe represents a significant milestone in the development of this novel immuno-oncology therapy, which aims to restore immune competence and benefit patients unresponsive to existing treatments.