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Safety and Diagnostic Efficacy of 177Lu-AF03 in Patients With Solid Tumors
Sponsor: Yong He
Summary
This study evaluates 177Lu-AF03, a bispecific heterodimeric peptide targeting both FAP and integrin αvβ6, for safety, biodistribution, radiation dosimetry, and preliminary diagnostic efficacy in patients with malignant solid tumors. Preclinical studies showed enhanced tumor uptake, prolonged retention, and low uptake in non-target organs. Eight patients with confirmed malignant solid tumors will receive a single intravenous injection of 177Lu-AF03, followed by SPECT/CT imaging at multiple time points. Safety will be monitored until Day 7 post-injection.
Official title: A Single-Arm, Open-Label, Exploratory Clinical Study to Evaluate the Safety, Biodistribution, Radiation Dosimetry, and Preliminary Diagnostic Efficacy of a Novel SPECT Tracer 177Lu-AF03 in Patients With Malignant Solid Tumors
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
8
Start Date
2026-10-20
Completion Date
2028-12-31
Last Updated
2026-10-19
Healthy Volunteers
No
Conditions
Interventions
177Lu-AF03
177Lu-AF03 is a bispecific heterodimeric peptide radiolabeled with Lutetium-177, targeting both integrin αvβ6 and fibroblast activation protein (FAP). It is prepared by the Department of Nuclear Medicine, Zhongnan Hospital of Wuhan University, as an investigational agent and is not approved by any regulatory authority.
Locations (1)
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China