eligibility_summary
Inclusion: ≥18, unresectable advanced solid tumor (e.g., lung, H&N, esophageal, cervical, breast, bladder, gastric, biliary, skin SCC, liver, basal cell), progressed after ≥1 therapy with no standard options, measurable disease, ECOG 0–1, ≥3‑mo survival, adequate organs, contraception, tumor tissue available. Exclusion: prior Top1‑ADC, CNS mets, active skin/ocular disease, >G1 residual AEs, recent chemo/RT/surgery, major cardiac disease, ILD, recent TE/CVA, serious infection incl HBV/HCV/HIV, live vaccine, strong CYP3A4 meds, mAb allergy/IMP intolerance, other trials, substance abuse, pregnant/breastfeeding, unable to consent/comply, other cancer <5 y.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: AMT-116, an antibody–drug conjugate (ADC) given as monotherapy. Mechanism: a tumor‑antigen–binding monoclonal antibody delivers an intracellular cytotoxic payload, based on the exclusion of prior Top1‑inhibitor ADCs, AMT‑116 likely carries a topoisomerase I inhibitor. After receptor‑mediated internalization and lysosomal release, the payload inhibits Top1, causes DNA damage, and induces apoptosis, with potential bystander effects. Targets: malignant cells expressing the (unspecified) surface antigen, key pathways impacted are DNA replication/repair via topoisomerase I and S‑phase cell‑cycle progression. Trial: Phase 1/2 dose‑escalation/expansion in advanced solid tumors post‑standard therapy.