eligibility_summary
Eligibility: Unresectable locally advanced/metastatic HCC, AFP+ gastric cancer, germ cell tumors (incl. extragonadal yolk sac, non-dysgerminomas), or GPC3+ squamous NSCLC, ≥1 evaluable/measurable lesion (RECIST 1.1), ECOG ≤1, adequate organ function, tumor tissue available. Exclude prior anti‑GPC3/4‑1BB, active leptomeningeal/untreated brain mets, active/relapsing autoimmune disease, recent steroids/immunosuppression, other recent cancers, and serious lung/heart/bleeding/infections.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06427941 tests BGB-B2033 (IV) alone and with tislelizumab in advanced GPC3-positive tumors (HCC, AFP-producing gastric cancer, extragonadal yolk sac tumors, GPC3+ squamous NSCLC). BGB-B2033 is an investigational immunotherapy antibody designed to target glypican-3 (GPC3) on tumor cells and provide 4-1BB (CD137) costimulation to T cells (likely a GPC3-targeted 4-1BB agonist/bispecific), aiming to activate tumor-infiltrating T cells locally while limiting systemic toxicity. Tislelizumab is an anti–PD-1 IgG4 monoclonal antibody (checkpoint inhibitor) that restores T-cell function by blocking PD-1 signaling. Targeted cells/pathways: GPC3+ tumor cells, T-cell 4-1BB costimulatory pathway, PD-1/PD-L1 inhibitory pathway. Phase 1 assesses safety, PK/PD, and preliminary antitumor activity, and defines RP2D.