Kainova Therapeutics has dosed the first patient with its Treg-depleting monotherapy. 

The biopharmaceutical company dosed the patient in a Phase I/II clinical trial of DT-7012, a proprietary Treg depleting antiCCR8 monoclonal antibody, in patients with advanced solid tumours. 

The study is evaluating DT7012 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 tumours, and in selected tumour types in a Phase II component focused on clinical efficacy.  

The trial will determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) of DT7012 as monotherapy and assess its safety and tolerability in combination with pembrolizumab. 

The announcement represents the European expansion of Kainova Therapeutics’ DOMISOL trial, following the study’s initiation in Australia. 

“Dosing of the first patient in Europe marks an important step in the clinical maturation of our flagship programme, DT7012,” said Dr JeanMarie Cuillerot, Chief Medical Officer of Kainova Therapeutics. 

“The DOMISOL study has been designed to generate a comprehensive clinical and biological profile for DT7012 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.” 

“As our flagship programme, DT7012 is central to Kainova Therapeutics’ strategy and reflects our commitment to advancing breakthrough GPCR modulating therapies in immuno–oncology and inflammation,” added Sean MacDonald, Chief Executive Officer of the company. 

“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.”