eligibility_summary
Eligible: ≥21, advanced solid tumor lacking options, RECIST-measurable, FAP+ on 68Ga-FAPI PET/CT, ECOG 0–1, adequate organs, AEs ≤G1, surgery ≥4 wk prior, contraception. Exclude: pregnant/breastfeeding, allergy, recent chemo/RT/immunotx, prior radiopharm or renal/extensive BM EBRT, unrecovered surgery or life expectancy <6 mo, liver >80% or marrow >25%, QTcF>470, active HBV/HCV/HIV, brain mets unless treated/stable, uncontrolled illness/DM, incontinence, other cancers, noncompliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase I, open-label dose-escalation of 177Lu-LNC1004, a fibroblast activation protein (FAP)-targeted radiopharmaceutical (Lu-177 beta-emitting radioligand). Single IV dose every 6 weeks for 2 cycles at 30/60/80/100 mCi to assess safety, dosimetry, and MTD in adults with FAP-positive advanced solid tumors (by 68Ga-FAPI-46 PET). Mechanism: LNC1004 binds FAP on cancer-associated fibroblasts, the Lu-177 payload delivers localized beta radiation, inducing DNA damage and cell death with cross-fire/bystander effects on nearby tumor cells. Targeted cells/pathways: FAP-expressing stromal fibroblasts in the tumor microenvironment involved in extracellular matrix remodeling, antigen-directed radioligand therapy rather than enzymatic pathway inhibition.