eligibility_summary
Inclusion: 18–75, ECOG 0–1, life expectancy ≥3 mo, advanced unresectable/metastatic/recurrent TNBC (ER/PR<1%, HER2−), Cohort2 PD‑L1 CPS≥1. C1: ≥1 prior metastatic line or relapse ≤6 mo post‑adjuvant. C2: no prior metastatic therapy, relapse ≥12 mo. Baseline tissue, RECIST measurable, adequate labs, LVEF≥50%, QTcF≤470/450. Exclusion: prior CCR8 (±eribulin/nab‑paclitaxel per cohort), therapy <2 wks, AEs>G1, unstable brain mets, uncontrolled effusion, ≥G3 antibody allergy, immunosuppression, autoimmune disease, ILD/pneumonitis.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06387628 (Phase II) tests LM-108 + toripalimab with chemotherapy (eribulin or nab‑paclitaxel) in recurrent/metastatic TNBC. Drugs and mechanisms: • LM-108: anti-CCR8 monoclonal antibody, targets CCR8 on tumor-infiltrating regulatory T cells (Tregs) to deplete/suppress Tregs and relieve immunosuppression. • Toripalimab: anti–PD-1 IgG4 checkpoint inhibitor, blocks PD-1 to reinvigorate exhausted effector T cells. • Eribulin: non-taxane microtubule dynamics inhibitor, causes mitotic arrest/apoptosis. • Nab-paclitaxel: albumin-bound taxane, stabilizes microtubules, causing mitotic arrest. Cells/pathways targeted: CCR8+ Tregs in the tumor microenvironment, PD‑1/PD‑L1 checkpoint on T cells, and microtubules in proliferating tumor cells.