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Study of 177LuLu-XT117 Treatment in Adults With Advanced Solid Tumors Showing FAP Positivity Evaluating Safety, Dosage, and Early Effectiveness
Led by Xinlu Wang · Updated on 2024-01-09
20
Participants Needed
1
Research Sites
52 weeks
Total Duration
AI-Summary
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.
CONDITIONS
Brief Title
A Clinical Study of [177Lu]Lu-XT117 Injection in Patients With Advanced Solid Tumors
Research Team
R
Ruiyue Zhao
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