Safety and efficacy of ¹⁷⁷Lu-FAPI-XT radioligand therapy in patients with advanced sarcoma and other cancer entities: first-in-human, dose-escalation study.

ABSTRACT: ‌PURPOSE‌: This phase I, first-in-human study evaluated the safety, dosimetry, and preliminary efficacy of ¹⁷⁷Lu-FAPI-XT, a novel fibroblast activation protein (FAP)-targeted radioligand, in patients with advanced solid tumors refractory to standard therapies. ‌METHODS‌: This open-label, non-randomized, dose-escalation, investigator-initiated trial had a "accelerated titration" and "3 + 3" design involved a 6-week ¹⁷⁷Lu-FAPI-XT treatment cycle in patients with advanced-stage solid tumors at 3.7GBq initially, with subsequent cohorts receiving an incremental 1.85GBq dose increase until dose limiting toxicity (DLT) was observed. ‌RESULTS‌: ¹⁷⁷Lu-FAPI-XT was well tolerated and no DLT or grade ≥ 3 treatment-related adverse events (TRAE) were observed. The whole-

SUBMITTER: Liu H 

PROVIDER: S-EPMC12860811 | biostudies-literature | 2026 Feb

REPOSITORIES: biostudies-literature