Phase 1 Study of 225AcAc-FAPI-XT Injection for Treating Advanced Solid Tumors in Adults

What this Trial Is About

Researchers are evaluating the safety, tolerability, dosimetry, and preliminary effectiveness of 225AcAc-FAPI-XT injection in patients with advanced solid tumors that express fibroblast activation protein FAP. This early-phase clinical study focuses on patients whose cancer has progressed despite standard treatments or who lack effective standard options. The trial aims to better understand how this targeted therapy behaves in the body and its potential impact on tumor control. Participants will receive doses of 225AcAc-FAPI-XT also called XT117 given every 6 weeks. This is a single-arm study, meaning all participants receive the same investigational drug without a comparison group. The treatment targets FAP-positive tumors and involves monitoring for any side effects and measuring tumor response over time. The study treatment is administered under careful medical supervision to assess tolerance and possible benefits. Throughout the study, participants will undergo regular evaluations including scans, laboratory tests, and clinical assessments to monitor safety and tumor response. Researchers will track side effects and dose-limiting toxicities for up to two years following treatment. They will also measure outcomes such as overall response rate, duration of response, disease control rate, and progression-free survival. This comprehensive monitoring helps understand the treatments profile and guides future development. Total participation duration varies based on individual response and study timelines.

A Clinical Study of [225Ac]Ac-FAPI-XT(XT117) Injection in Patients With Advanced Solid Tumors