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NOT YET RECRUITING
NCT07879547
EARLY_PHASE1

Safety and Diagnostic Efficacy of 177Lu-AF03 in Patients With Solid Tumors

Sponsor: Yong He

View on ClinicalTrials.gov

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

Interventions

DRUG

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