eligibility_summary
Eligibility: ECOG 0–1, confirmed advanced/metastatic/unresectable solid tumor, ≥1 measurable lesion (RECIST 1.1), archived tumor tissue, adequate organ function, contraception (F ≥7 mo, M ≥4 mo post‑treatment). Exclude: prior B7H3 therapy, prior topo‑I ADCs (Part B/Phase 1b), active CNS disease (cord compression, leptomeningeal, uncontrolled brain mets), other cancer <2 y, ILD/≥Gr2 pneumonitis, O2 sat <92%/oxygen, uncontrolled diabetes or >Gr1 electrolytes ≤14 d, infection ≤14 d.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1, first-in-human trial testing: 1) BGB-C354, a B7-H3 (CD276)–targeted antibody-drug conjugate (ADC). Mechanism: the monoclonal antibody binds B7-H3 on tumor cells, is internalized, and releases a cytotoxic payload to induce tumor cell death. ADC type: targeted cytotoxic immunotherapy. 2) Tislelizumab, an anti–PD-1 monoclonal antibody (checkpoint inhibitor). Mechanism: blocks PD-1 on T cells to restore/exhaustion-reverse T-cell antitumor activity. Targets/pathways: B7-H3–expressing tumor cells (and potentially tumor-associated vasculature/stroma) via ADC-mediated killing, PD-1/PD-L1 immune checkpoint on T cells to enhance adaptive antitumor immunity. The study evaluates BGB-C354 alone and combined with tislelizumab in advanced solid tumors.