Phase 1/2 DT-7012 anti-CCR8 monoclonal antibody (Treg-depleting immunotherapy) in solid tumors.

This first-in-human, multicenter, open-label Phase 1/2 study (DOMISOL; DT-7012-CLI-001) evaluates DT-7012, a CCR8-targeting monoclonal antibody designed to deplete CCR8+ intratumoral regulatory T cells (Tregs) and relieve tumor immune suppression, as monotherapy and combined with an approved immune checkpoint inhibitor (ICI). Part 1A escalates DT-7012 alone; Part 1B escalates DT-7012 + ICI after safety review; Phase 2 expands into indication-specific cohorts to look for efficacy signals alongside continued safety/PK/PD characterization (total planned ~125 participants). Domain Therapeutics Australia Pty Ltd sponsors the trial; the company has since rebranded to Kainova Therapeutics, which has discussed European expansion activities. Eligible patients have selected recurrent, locally advanced/metastatic solid tumors that progressed after ≥1 prior systemic line; current care in this setting is sequential systemic therapy by tumor type (chemo, targeted therapy when biomarker-matched, and PD-1/PD-L1–based immunotherapy in responsive histologies), and this tests whether CCR8+ Treg depletion can deepen or restore ICI activity.