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Clinical Trial · NCT07299253
Preclinical Safety Evaluation and First-in-Human Translational Study of [177Lu]Lu-TEFAPI-06
Overview
This study aims to systematically evaluate the safety, biodistribution, dosimetry, and preliminary therapeutic potential of \[177Lu\]Lu-TEFAPI-06 through an exploratory first-in-human (FIH) trial.
Drug / Compound
TEFAPI-06
Isotope(s):
LUTETIUM-177
Radioisotope: Lu-177
Theranostic Role: Therapeutic Agent & SPECT Imaging
T1/2 (Half-Life): 6.7 Days
Decay Mode: BETA, GAMMA
Energy: Eβeta max 497 keV, Gamma 113-208 keV
Range: In Tissue: 0.25-2mm
Decay Daughters: Hf177
Status: FDA Approvals: PLUVICTO® (2022), LUTATHERA® (2017)
Target(s):
- FAP
Ligand Class: Small Molecules
Chelator: DOTA
Linker: 4-(p-iodophenyl)butyric acid
Eligibility
Inclusion
- At least one FAP-avid lesion confirmed by baseline \[18F\]-FAPI PET/CT
- Life expectancy \> 3 months
- Adequate organ and bone marrow function prior to the first dose
- Histologically confirmed advanced metastatic solid tumors refractory or intolerant to standard therapies
- ECOG performance status 0-2
Exclusion
- Severe hepatic or renal dysfunction
- Chemotherapy, radiotherapy, or targeted therapy within 4 weeks
- Uncontrolled active infection or severe comorbidities
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