Study of 177LuLu-XT117 Injection to Assess Safety and Effectiveness in Patients With Advanced FAP-positive Solid Tumors

What this Trial Is About

Researchers are evaluating the safety, tolerability, dosimetry, and early effects of 177LuLu-XT117 injection in patients with advanced solid tumors that test positive for fibroblast activation protein FAP. This Phase 1, single-center, single-arm study focuses on dose escalation to find the dose that limits toxicity, determine the highest tolerated dose, recommend a dose for further study, and understand dosimetry characteristics of the treatment. Participants will receive fixed dose levels of 177LuLu-XT117, a radiopharmaceutical therapy combining a beta-emitting radioactive element with XT117. Doses will be given every 6 weeks. The study includes a dose escalation phase to evaluate safety and dosing limits. During the study, participants will be closely monitored for treatment-related side effects, dose-limiting toxicities, and the maximum tolerated dose up to 6 weeks after treatment. Researchers will assess response rates, disease control, progression-free and overall survival every 6 weeks for up to 2 years. Radiation dosimetry will be measured at multiple time points after the first dose. Participation may last up to 2 years with ongoing safety and efficacy evaluations.

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