eligibility_summary
Eligible: Adults (≥18) with consent, advanced/metastatic or unresectable solid tumors after SOC failure or not candidates, measurable disease, ECOG 0–1, adequate organs, contraception. Exclude: recent therapy/surgery/radiation, unresolved ≥G2 tox, prior PD‑1/PD‑L1 stopped for toxicity, symptomatic CNS mets, leptomeningeal disease or cord compression, recent other malignancy, severe hypersensitivity, active HIV/HBV/HCV/TB/COVID (controlled HIV ok), live vaccines, cardiovascular disease, autoimmune needing systemic treatment, ILD, immunodeficiency/steroids >10 mg, prior transplant, pregnancy/breastfeeding.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
A first-in-human Phase 1 trial tests DM919 (intravenous anti-MICA/MICB monoclonal antibody) alone and with pembrolizumab (intravenous anti–PD-1 monoclonal antibody) in advanced solid tumors. DM919 targets tumor-expressed MICA/MICB, stress ligands for the NKG2D receptor, and is designed to maintain/restore MICA/B on the tumor surface and opsonize tumor cells, enhancing: NKG2D-driven cytotoxicity by NK and CD8+ T cells, and Fc gamma receptor–mediated ADCC/ADCP by NK cells and macrophages. Pembrolizumab blocks the PD-1/PD-L1 checkpoint to reinvigorate exhausted T cells. Cells/pathways targeted: tumor cells expressing MICA/B, NK and CD8+ T cells via the NKG2D–MICA/B axis, Fc gamma receptor pathways (NK cells, macrophages), and the PD-1/PD-L1 inhibitory pathway. Primary aim: identify a safe, active dose and signal of efficacy across solid tumors.