drugset / Trial / NCT05410821

Evaluation of 177Lu-DOTA-EB-FAPI in Patients With Metastatic Radioactive Iodine Refractory Thyroid Cancer

NCT05410821 ↗

Non-randomizedSingle-groupOpen-labelTreatment

Summary

Increased fibroblast activation protein expression is positively correlated with the dedifferentiation and aggressiveness of thyroid cancer. Radiolabeled fibroblast activation protein inhibitor therapy, also known as radioligand therapy has become a novel treatment for patients with radioactive iodine refractory thyroid cancer and disease progression after first-line treatment. However, a major problem in the therapeutic use of 177Lu-DOTA-FAPI has been its short half-life and fast rate of clearance. This study was designed to evaluate the safety, tolerability, and maximum tolerated dose of a long-lasting radiolabeled fibroblast activation protein inhibitor 177Lu-DOTA-EB-FAPI in mRAIR-TC patients with PD after TKIs treatment.

Timeline

Start
2022-06-15
Primary completion
2024-06-15
Completion
2025-03-27

Drugs

EvaluationDrugModalityDoseRoute
Subject 177Lu-DOTA-EB-FAPI Other / unclassified 2220 mbq Intravenous
Subject 177Lu-DOTA-EB-FAPI Other / unclassified 3330 mbq Intravenous
Subject 177Lu-DOTA-EB-FAPI Other / unclassified 4990 mbq Intravenous