Phase 1/2 UI-102 cholesteryl-pullulan nanoparticle TLR7/8 agonist immunostimulant in solid tumors.

This first-in-human, open-label Phase 1/2 trial evaluates UI-102, a small-molecule Toll-like receptor 7/8 (TLR7/8) agonist formulated in a cholesteryl pullulan (CHP) nanoparticle for IV infusion, sponsored by United Immunity, Co., Ltd. The study uses dose escalation plus dose optimization/backfill and cohort expansion to define safety/tolerability, pharmacokinetics/pharmacodynamics, and early anti-tumor activity in selected locally advanced or metastatic solid tumors (2nd line+). The core scientific angle is systemic innate-immune activation with a delivery system intended to bias exposure toward myeloid cells (macrophages/dendritic cells), including immunosuppressive M2-like tumor-associated macrophages, to help “reprogram” the tumor microenvironment and potentially improve responses to standard agents in combination cohorts. Today’s care for most advanced solid tumors after progression is sequential systemic therapy (tumor-type–specific chemotherapy, targeted therapy when actionable alterations exist, and checkpoint inhibitors/IO combinations when indicated), but many patients become refractory, creating space for a broadly applicable myeloid-targeting immunotherapy backbone.