eligibility_summary
Key eligibility: Women 18–75, ECOG 0–1, ≥6‑mo life expectancy, biopsy‑proven cervical (squamous/adeno/adenosquamous/small cell), measurable disease (RECIST 1.1), adequate organ function, HER2 IHC ≥1+, negative pregnancy test and contraception. Exclude: other malignancy <5y (except certain in situ/skin), prior allogeneic/solid transplant, systemic therapy <4w or unresolved >G1 AEs, live vaccine <4w (COVID‑19 allowed), immunodeficiency, prior ADCs, not recovered from surgery, drug allergy, NYHA ≥III, active serious infections (HIV/HBV/HCV/TB), uncontrolled comorbidities.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Single-arm Phase II trial in recurrent HER2-expressing cervical cancer tests RC48 (disitamab vedotin) plus tislelizumab. RC48 is a HER2-targeted antibody–drug conjugate (ADC) carrying MMAE, it binds HER2 on tumor cells, is internalized, releases MMAE to disrupt microtubules, causing cell-cycle arrest/apoptosis (with potential bystander effect). Tislelizumab is a humanized IgG4 anti–PD-1 immune checkpoint inhibitor that blocks PD-1/PD-L1 signaling to restore cytotoxic T-cell activity. Targets/pathways: HER2 on cervical cancer cells, intracellular microtubules (via MMAE), PD-1 on T cells and the PD-1/PD-L1 checkpoint in the tumor microenvironment.