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177Lu-NI-FAPI
- Development stage
- Phase 2
- Lead developer
- Peking Union Medical College Hospital
- Modality
- Antibody-Radionuclide Conjugates → Antibody Conjugates → Antibody-Based Therapeutics, Beta-minus Emitters → Radiopharmaceuticals, Gamma Emitters → Radiopharmaceuticals, Small Molecules
- Administration
- Intravenous
01
Overview
177Lu-NI-FAPI (also known as 177Lu-DOTA-NI-FAPI-04) is a novel dual-targeting therapeutic radiopharmaceutical developed by Peking Union Medical College Hospital. It consists of a fibroblast activation protein (FAP)-targeting quinoline-based ligand (FAPI-04) conjugated to a hypoxia-sensitive nitroimidazole (NI) moiety and labeled with the beta-emitting radionuclide lutetium-177 (177Lu) via a DOTA chelator. The drug is designed to target both FAP-expressing cancer-associated fibroblasts (CAFs) in the tumor stroma and hypoxic regions within the tumor microenvironment. Upon binding to FAP, the nitroimidazole moiety undergoes bioreductive trapping in hypoxic areas, enhancing tumor retention and accumulation. The beta radiation emitted by lutetium-177 then delivers localized cytotoxic radiation to destroy tumor cells. 177Lu-NI-FAPI is being evaluated in clinical trials for the treatment of advanced solid tumors and fibroblast activation-related tumors.
- Other names
- [177Lu]Lu-DOTA-NI-FAPI-04[177Lu]Lu-NI-FAPI[177Lu]Lu-NI-FAPI-04lutetium (177Lu) DOTA-NI-FAPI-04lutetium Lu 177 DOTA-NI-FAPI-04
02
Targets
DNAFAP (Fibroblast activation protein alpha)
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