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

Summary

This is a single-center, single-arm clinical study to evaluate the safety, tolerability, dosimetry and preliminary efficacy of \[177Lu\]Lu-XT117 injection in patients with FAP-positive advanced solid tumors. Dose escalation will be conducted to determine the Dose Limiting Toxicity (DLT), Maximum Tolerated Dose (MTD), Recommended Phase 2 Dose (RP2D), and to assess dosimetry characteristics.

Timeline

Start

2024-01

Primary completion

2025-12

Completion

2026-12

Publications

• Liu H, Guo R, Zhang X, Ji H, Sun S, Sun S, Liu J, Yang Z, Wang R. Safety and efficacy of 177Lu-FAPI-XT radioligand therapy in patients with advanced sarcoma and other cancer entities: first-in-human, dose-escalation study. Eur J Nucl Med Mol Imaging. 2026 Feb;53(3):1869-1880. doi: 10.1007/s00259-025-07617-0. Epub 2025 Oct 15.

Drugs

Indications