eligibility_summary
Inclusion: unresectable/metastatic HLA‑G+ solid tumors lacking effective therapy, measurable disease (RECIST 1.1), ECOG 0–1, life ≥12 wks, adequate organ function, contraception Exclusion: untreated CNS/leptomeningeal mets, threatening disease, recent other malignancy, uncontrolled HTN, ILD/pneumonitis or high pulmonary bleed risk, PE <3 mo, major CV disease, active infection incl HBV/HCV/HIV, indwelling line/drain, active autoimmune disease, surgery/therapy/steroids/live vaccine <28 d, prior T‑cell engager/adoptive therapy, drug hypersensitivity
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Interventions and mechanisms: RO7515629 is an investigational bispecific T‑cell–engaging monoclonal antibody (IV) designed to bind HLA‑G on tumor cells and CD3 on T cells, redirecting T‑cell cytotoxicity and overcoming HLA‑G–mediated immune suppression. Tocilizumab (Actemra/RoActemra), an anti–IL‑6 receptor monoclonal antibody, is used as rescue therapy for cytokine release syndrome. Cells/pathways targeted: HLA‑G–positive tumor cells, CD3+ T cells (T‑cell activation and killing). The study aims to counter the HLA‑G immune checkpoint axis that suppresses anti‑tumor immunity via inhibitory receptors (e.g., LILRB1/ILT2, LILRB2/ILT4, KIR2DL4) and to modulate IL‑6 signaling during CRS. Indications include RCC, NSCLC, pancreatic, colorectal, and ovarian cancers.