eligibility_summary
Adults ≥18 with advanced/metastatic solid tumors refractory/intolerant to standard therapy, measurable (RECIST 1.1), ECOG ≤2, archival tumor for EpCAM IHC, adequate organ function. Exclude: recent local/systemic therapy, immunotherapy or immunosuppression, major cardiac/pulmonary disease, thromboembolism ≤6 mo, prior EpCAM therapy, active TB, HIV, high HBV, HCV RNA+, recent live vaccine/other IP, severe allergy to antibodies/AM-928, uncontrolled CNS mets/effusions, prior transplant.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: AM-928, a humanized anti-EpCAM monoclonal antibody (biologic), administered by weekly IV infusion (0.1–15 mg/kg) in dose escalation for advanced solid tumors. Mechanism of action: Specifically binds epithelial cell adhesion molecule (EpCAM) on tumor cells, intended to inhibit EpCAM-mediated cell adhesion/signaling and flag EpCAM+ cancer cells for immune effector clearance via Fc-dependent mechanisms (e.g., ADCC/CDC), leading to tumor cell death. Targets: EpCAM-expressing epithelial-derived solid tumor cells, key pathways include EpCAM-driven adhesion/signaling on tumor cells and Fc receptor–mediated immune cytotoxicity. Primary aims: safety, tolerability, PK, and preliminary efficacy.