Study of 177LuLu-XT117 Treatment in Adults With Advanced Solid Tumors Showing FAP Positivity Evaluating Safety, Dosage, and Early Effectiveness

What this Trial Is About

Researchers are evaluating the safety, tolerability, dosimetry, and preliminary efficacy of 177LuLu-XT117 injection in patients with advanced solid tumors that express fibroblast activation protein FAP. This is a Phase 1, single-center, single-arm clinical study focusing on patients who have FAP-positive tumors and have failed or lack standard treatments. Participants will receive doses of 177LuLu-XT117, a radiopharmaceutical therapy combining the beta emitter Lu-177 with XT117. The treatment is administered every 6 weeks. The study monitors radiation dosimetry at specific time points after the first dose and continues evaluations throughout the treatment period. During the study, participants will be regularly assessed for treatment-emergent adverse events for up to 6 months after the last dose. Researchers will also evaluate tumor response and survival outcomes every 6 weeks for up to 2 years, including overall response rate, duration of response, disease control rate, progression-free survival, and overall survival. Radiation exposure to the whole body and organs is measured at multiple intervals after treatment to understand distribution and safety.

A Clinical Study of [177Lu]Lu-XT117 Injection in Patients With Advanced Solid Tumors