Domain Therapeutics has announced the first patients have been dosed in its phase 1/2 DOMISOL clinical trial of DT-7012, a differentiated Treg-depleting anti-CCR8 monoclonal antibody designed to treat solid tumours.
The open-label, multicentre trial is being conducted in Australia, with initial sites including Peninsula and Southeast Oncology (PASO) and Cabrini Health in Melbourne. The study will assess safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumour activity in adults with selected advanced solid tumours.
Stephan Schann, Chief Scientific Officer of Domain Therapeutics, explained: “CCR8 has rapidly emerged as a highly competitive target, drawing significant interest across the industry, including from leading pharmaceutical companies.
“DT-7012 stands out with its unique and differentiating properties, offering unprecedented selectivity in depleting intratumoral Tregs while simultaneously improving overall immune system function. These features are critical for effective cancer immunotherapy, positioning DT-7012 as a promising candidate to overcome immune resistance and bring hope to patients with limited treatment options.”
Professor Vinod Ganju, Principal Investigator at PASO, said: “Immune checkpoint inhibitors (ICIs) have revolutionized cancer treatment, yet a significant unmet need remains as Tregs suppress immune response, driving resistance to ICIs and limiting their effectiveness.
“We are excited to participate in this important trial and offer patients access to a highly promising therapeutic candidate that could make Treg depletion a reality in cancer therapy. DT-7012 adds to the growing momentum around CCR8, complementing another CCR8-targeting asset currently undergoing significant patient expansion.”
Sean A MacDonald, Chief Executive Officer of Domain Therapeutics, added: “Dosing of the first patients in the DOMISOL trial represents a significant milestone, as DT-7012 becomes our second fully proprietary asset to enter the clinic, underscoring our proven ability to translate cutting-edge GPCR biology into high value differentiated products.”
