eligibility_summary
Adults ≥18 with unresectable/metastatic melanoma progressing on anti‑PD‑1/L1 (uveal exempt), ≥1 measurable lesion, ECOG 0–1, adequate labs, life expectancy ≥12 wks, prior BRAF/MEK allowed, biopsy required. Exclude: prior anti‑CTLA‑4/LAG3, severe irAEs, recent chemo/IO/radiation/surgery/live vaccine/other trials, immunodeficiency/immunosuppression, active CNS mets/autoimmune/pneumonitis, active infection/CV disease, pregnancy, hypersensitivity, HIV/amyloidosis, confounding conditions.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions and type: BI-1607 (Fc‑engineered monoclonal antibody against FcγRIIB/CD32B), ipilimumab (anti‑CTLA‑4 IgG1 monoclonal antibody), pembrolizumab (anti‑PD‑1 IgG4 monoclonal antibody). Mechanisms of action: BI-1607 blocks the inhibitory FcγRIIB receptor on B cells and myeloid cells (macrophages, dendritic cells), shifting FcγR signaling toward activation to enhance antibody effector functions, antigen presentation, and potentially intratumoral Treg depletion by Fc‑competent antibodies, it is intended to boost the activity of CTLA‑4/PD‑1 checkpoint blockade. Ipilimumab blocks CTLA‑4 to enhance T‑cell priming and can deplete tumor Tregs via FcγR‑mediated ADCC/ADCP. Pembrolizumab blocks PD‑1 to reinvigorate exhausted T cells. Cells/pathways targeted: FcγRIIB ITIM signaling on B/myeloid cells, CTLA‑4/CD28 costimulation axis, PD‑1/PD‑L1 inhibitory axis, CD8+ T cells, Tregs, tumor‑associated macrophages, dendritic cells.