eligibility_summary
Adults ≥18 with advanced/metastatic solid tumors post failure/intolerance or no standard therapy. Washout: ≥28 d systemic/other trial drugs, ≥14 d endocrine/TCM. Prior AEs ≤G1. Need measurable disease, ECOG 0–1, life ≥12 wks, adequate organs, negative pregnancy, contraception to 6 mo. Exclude: recent other cancers, transplant, uncontrolled effusions, unstable brain mets, major CV disease, ILD/pneumonitis, HIV/HBV/HCV/TB, autoimmune/immunosuppression, recent infection/surgery/live vaccines, prior ICI/4‑1BB, mAb allergy, pregnancy, substance abuse.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: HLX35 (recombinant humanized bispecific IgG antibody targeting EGFR and 4-1BB/CD137) plus HLX10 (recombinant humanized anti-PD-1 monoclonal IgG). Mechanisms: HLX35 binds EGFR on tumor cells to localize activity and agonizes 4-1BB on activated T cells/NK cells, delivering TNFRSF9 costimulatory signals that boost cytotoxicity and memory responses. HLX10 blocks the PD-1 immune checkpoint on T cells, reversing exhaustion and restoring effector function. Targets/pathways: EGFR on tumor cells (EGFR signaling), 4-1BB on activated T cells and NK cells (costimulatory pathway), and the PD-1/PD-L1 inhibitory axis on T cells. Aim: synergistic T-cell activation and antitumor immunity in advanced/metastatic solid tumors.