eligibility_summary
Adults ≥18 with recurrent/metastatic solid tumors after standard tx, ECOG 0–1, ≥3‑mo life expectancy, adequate labs, prior AEs ≤G1 (alopecia ≤G2), consent. Contraception, no gamete donation or breastfeeding (for 6 mo post‑tisotumab vedotin). Exclude: bleeding/cardiac risks, CNS AVM/aneurysm/stroke, cicatrizing ocular disease or transplant, recent surgery (major <4 wks, minor <7 d), neuropathy ≥G2, prior MMAE, immunodeficiency/recent immunosuppression, any unsafe condition.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Tisotumab vedotin—an antibody-drug conjugate (ADC) comprising a human monoclonal IgG1 targeting tissue factor (TF/CD142) linked via a protease-cleavable linker to the cytotoxic payload monomethyl auristatin E (MMAE), a microtubule inhibitor. Mechanism: Binds TF on tumor cells, is internalized, and releases MMAE intracellularly to inhibit tubulin polymerization, causing G2/M arrest and apoptosis, membrane-permeable MMAE can produce bystander killing, the IgG1 may also engage Fc-mediated effector functions. Cells/pathways targeted: TF-overexpressing tumor cells across solid malignancies, TF/FVIIa/PAR-2 signaling axis on tumor and stromal compartments, intracellular microtubule dynamics. Trial focus: PK, immunogenicity, safety, and preliminary efficacy of IV tisotumab vedotin 2.0 mg/kg Q3W in Chinese patients with metastatic/recurrent solid tumors.