eligibility_summary
Inclusion: adults (>=18) with ECOG 0-1, histologically confirmed solid tumor with measurable disease, failed/no standard therapy, FAP-positive PET/CT, adequate marrow/organ function. Exclusion: unsuitable high off-target uptake, recent anticancer therapy, uncontrolled diabetes, major cardiovascular disease or long QTc, recent VTE, major surgery, severe GI disease, active infection, ILD/severe lung disease, active CNS disease (stable/asymptomatic allowed), uncontrolled effusions.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: [177Lu]Lu-XT117, a FAP-targeted radiopharmaceutical (177Lu-labeled small-molecule FAPI ligand). Mechanism of action: selectively binds fibroblast activation protein (FAP), a membrane serine protease highly expressed on cancer-associated fibroblasts (CAFs) in the tumor stroma, delivers β-emitting lutetium-177 to induce localized DNA double-strand breaks and cell death, with crossfire irradiation of adjacent tumor cells. Targets: FAP-expressing CAFs and the tumor microenvironment/stromal compartment, FAP protease pathway implicated in matrix remodeling, tumor growth, and invasion. Trial: Phase 1, single-arm, assessing safety, tolerability, dosimetry, and preliminary efficacy in FAP-PET–positive advanced solid tumors, dosing every 6 weeks.