FL-261 Imaging for Cancer Diagnosis and Staging

c-MET is a receptor tyrosine kinase overexpressed in multiple malignancies and associated with tumor progression, therapeutic resistance, and poor prognosis, while showing limited expression in normal tissues, making it an attractive imaging and therapeutic target. Current assessment relies on invasive biopsy and is limited by tumor heterogeneity and sampling bias. FL-261 is a novel c-MET-targeting ligand with high affinity and specificity, favorable tumor uptake and retention, rapid background clearance, and good preclinical safety. It can be radiolabeled for both diagnostic imaging and potential theranostic applications. This first-in-human study will evaluate \[68Ga\]Ga-FL-261 PET or \[111In\]In-FL-261 SPECT imaging in patients with advanced malignancies, including non-small cell lung cancer, colorectal cancer, and head and neck cancer. The study aims to assess safety, biodistribution, and tumor-targeting capability, and to explore its diagnostic value by correlating imaging findings with histopathological c-MET expression.

NCT Number	NCT07510321
Lead Sponsor	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Conditions	Non-Small Cell Lung Cancer, Colorectal Cancer, Head & Neck Cancer, Advanced Solid Tumors
Enrollment	12 participants
Start Date	2025-11-27
Primary Completion	2026-06-30 (estimated)
Study Completion	2026-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-04-03