eligibility_summary
Eligibility: Arm1—advanced/metastatic solid tumors after all beneficial therapy. Arm2—advanced/metastatic NSCLC (non-surgical), EGFR/ALK/ROS1 not indicated, PD-L1 TPS ≥50%. All: measurable disease, archival/biopsy tissue, ECOG 0–1, life ≥3 mo. Key exclusions: symptomatic effusions, ≥Grade 2 neuropathy, severe ocular disease, IBD, major CV/CVA disease, prior TROP2 or topo‑I ADCs, prior PD-(L)1/systemic NSCLC therapy (Arm2), active CNS mets, ILD/pneumonitis, serious infection, HIV, active HBV/HCV, recent therapy/vaccines, strong CYP3A4 meds.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1 (Japan) testing: 1) Sacituzumab tirumotecan (MK-2870/SKB264) monotherapy—an antibody-drug conjugate (ADC) targeting TROP2 that delivers a topoisomerase I inhibitor (tirumotecan). Mechanism: antibody binds TROP2 on tumor cells, internalizes, releases topo‑I inhibitor to cause DNA damage and cell death (possible bystander effect). 2) Combination of sacituzumab tirumotecan with pembrolizumab (MK-3475)—a monoclonal antibody immune checkpoint inhibitor that blocks PD‑1 on T cells, preventing PD‑1 interaction with PD‑L1/PD‑L2 and enhancing antitumor T‑cell activity. Targets/pathways: TROP2 on epithelial tumor cells, DNA replication/repair via topoisomerase I, PD‑1 checkpoint on T cells and PD‑L1/PD‑L2 on tumor/immune cells. Carboplatin combo arm was discontinued.