eligibility_summary
Eligibility: ECOG 0–1, survival ≥3 mo, measurable disease (RECIST 1.1), tumor tissue available, adequate organ/marrow function, recovered from prior therapy. Cancers: recurrent/metastatic cervical/urothelial/ovarian, metastatic prostate, advanced endometrial. Exclude: active/untreated CNS mets, major CV disease/uncontrolled illness, active HBV/HCV/TB or uncontrolled HIV, allergy to pembrolizumab/SKB264, prior TROP2 therapy, recent live vaccine, other trials, investigator concern.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2, open-label basket trial testing SKB264 plus pembrolizumab in cervical, urothelial, ovarian, prostate, and endometrial cancers. Drugs and mechanisms: - SKB264: antibody-drug conjugate (ADC) targeting TROP2 on tumor cells, after binding and internalization, releases a topoisomerase I inhibitor payload that causes DNA damage and tumor cell death (with potential bystander effect). - Pembrolizumab: monoclonal antibody immune checkpoint inhibitor that blocks PD-1 on T cells, restoring antitumor T-cell activity. Cells/pathways targeted: - TROP2-expressing epithelial tumor cells, topoisomerase I/DNA replication machinery leading to apoptosis. - PD-1/PD-L1 immune checkpoint on T cells and tumor/immune cells to enhance cytotoxic T-cell responses. Rationale: ADC-mediated tumor killing and antigen release may synergize with PD-1 blockade to amplify antitumor immunity.