eligibility_summary
Adults ≥18, consent, ECOG 0–1, RECIST‑measurable. Coh A: untreated PD‑L1+ (TPS≥1%) stage IIIB/IV NSCLC, EGFR/ALK/ROS1−. Coh B: HCC BCLC B/C not LRT‑amenable/refractory, Child‑Pugh A, progressed/intolerant to sorafenib/lenvatinib or atezo+bev. Exclude: recent investigational Rx, prior anti‑CTLA‑4, severe prior IO AEs, pneumonitis/ILD, steroids/immunosupp., autoimmune, CV/QTc, active HBV/HCV/HIV/TB/COVID. B: variceal bleed, liver tumor ≥60%, Vp4/IVC/heart invasion, encephalopathy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Study: Open-label, single-arm Phase 2 (withdrawn) of YH001 plus toripalimab in advanced PD-L1+ NSCLC (1st line) and previously treated HCC (2nd line). Drugs/interventions: • YH001: investigational monoclonal antibody immune checkpoint inhibitor targeting CTLA-4 (likely IgG1). Mechanism: blocks CTLA-4 to enhance CD28/B7 costimulation and T-cell priming, Fc-enabled activity may deplete intratumoral regulatory T cells (Tregs) via ADCC. • Toripalimab: humanized IgG4 monoclonal antibody checkpoint inhibitor targeting PD-1. Mechanism: blocks PD-1/PD-L1 interaction to reinvigorate exhausted effector T cells and boost antitumor cytotoxicity. Cells/pathways targeted: CD8+ and CD4+ T cells (activation/effector function), Tregs (depletion), APC–T cell synapse, CTLA-4 and PD-1 checkpoints (CD28/B7 and PD-1/PD-L1 signaling) in the tumor microenvironment.