eligibility_summary
Eligibility—Inclusion: Female ≥18, HER2+ (IHC1–3+, 2+ needs FISH) R/M cervical cancer after ≥1 platinum, not surgery/RT candidates, PD‑L1 confirmed, RECIST measurable, ECOG 0–1, adequate organ function incl LVEF ≥50%, negative pregnancy/contraception. Exclusion: CNS mets, recent therapy/surgery/live vaccine, unresolved ≥G2 AEs, active HBV/HCV/HIV/TB or severe infection, HF ≥3, recent GI perforation or major thrombosis/CVA, lung disease, uncontrolled illness, autoimmune disease, other cancer <5 y, prior allo‑HSCT/ADC, hypersensitivity, nonadherence.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II, single-arm study in HER2-expressing recurrent/metastatic cervical cancer after ≥1 platinum line failure tests: 1) Disitamab vedotin (RC48-ADC): an antibody-drug conjugate targeting HER2 (ERBB2). Mechanism: the anti-HER2 mAb binds HER2 on tumor cells, is internalized, and releases MMAE (a microtubule inhibitor) to disrupt microtubules, causing cell cycle arrest/apoptosis, can also induce ADCC and bystander killing. 2) Zimberelimab: an anti–PD-1 monoclonal antibody immune checkpoint inhibitor that blocks PD-1 to restore T-cell antitumor activity by preventing PD-1 interaction with PD-L1/PD-L2. Targeted cells/pathways: HER2-positive tumor cells, microtubule polymerization within tumor cells, PD-1 pathway on T cells and PD-L1/PD-L2 on tumor/immune cells, aiming to combine direct cytotoxicity with immune reactivation.