Domain Therapeutics Doses First Patients in Phase I / II Trial of DT-7012 Targeting CCR8 in Solid Tumors

DT-7012 is a proprietary, differentiated Treg-depleting anti-CCR8 monoclonal antibody
Differentiated binding capacities and competitive properties position it as a promising therapeutic to boost anti-tumor immunity, overcoming immunosuppression

Strasbourg, France – Montreal, Canada – Boston, United States, October 28, 2025: Domain Therapeutics ( “Domain” or “the Company” ), the GPCR experts harnessing deep receptor biology to develop breakthrough treatments for patients, today announced that the first patients have been dosed in its Phase I / II DOMISOL clinical study of DT-7012, a differentiated Treg-depleting anti-CCR8 monoclonal antibody for the treatment of solid tumors.

The DOMISOL study is an open-label, multicenter Phase I / II, first-in-human dose-escalation and cohort-expansion trial evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of DT-7012 in adult patients with selected advanced solid tumors. The trial is being conducted in Australia, with initial clinical sites including Peninsula and Southeast Oncology ( PASO ) and Cabrini Health in Melbourne. Additional centers are expected to come online in the coming months. For more information on the trial, visit: NCT06819735.

Stephan Schann, Chief Scientific Officer of Domain Therapeutics, said: “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, commented: “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.”

“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”, added Sean A. MacDonald, Chief Executive Officer of Domain Therapeutics. “Initiating this trial in Australia aligns with our strategy to accelerate clinical development and strengthens momentum behind our pipeline of drug candidates. As we continue to advance our programs and deliver value for stakeholders, we are proud to contribute to the introduction of a potentially groundbreaking therapeutic solution that could transform lives of cancer patients worldwide.”

ENDS

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

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